Biologics Drug Product: Strategies for Formulation, Tech Transfer and Delivery System
Summary: This webinar covers the key considerations for formulation screening of therapeutic proteins with a focus on maintaining protein stability and avoiding aggregation.
How to Commercially Scale T-cell Allogeneic Therapies
Summary: Jesse Trekker, PhD, Business Development Director at Catalent Cell & Gene Therapy, discusses an innovative manufacturing methodology and fill/finish approaches to accelerate T-cell therapies to the commercial readiness phase.
Accelerating Manufacturing for Investigational COVID-19 Therapeutic Candidate Lenzilumab
Summary: Catalent Biologics presents a case study on the investigational COVID-19 therapeutic candidate, lenzilumab, and its development from gene to late stage clinical trials.
The Faster Path to Self-Administration: Moving from Pre-Filled Syringe to Auto-Injector
Summary: Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more.
Technology Integrators in Cell and Gene Therapy: Powering Innovation
Summary: Julien Meissonnier, Catalent’s Vice President and Chief Scientific Officer, discusses innovative approaches, technology disrupters, and more in this webinar.
Getting Your Biologic to Clinic Faster and More Efficiently
Summary: Catalent experts Ann McMahon and Pamela Barton share examples where integrated drug product and clinical supply services enabled a client to expedite timelines or avoid costly errors.
Disease Prevention & Control Summit 2020: Manufacturing Drugs & Vaccines Panel
Summary: This webinar discusses the challenges associated with pandemic drug manufacture and the extent to which vials that store vaccines could become a constraint, as well as the requirements that are needed in delivery systems and cold chain logistics.
Delivering Speed and Results through Advanced Technology and Collaboration
Summary: Enzymes can be challenging to express and scale up to become biologic therapies. In order to develop their optimized tissue plasmigen activator (tPA) to treat patients with hemorrhagic stroke…
The Future of Orphan Drugs: Insights on the Current Market, Trends & Strategic Partnerships Driving Innovation
Summary: In this report, we will highlight the trends shaping the orphan-drug market, with a particular focus on expedited drug development. Expert insights on navigating development and manufacturing challenges with…
Endpoints 11 Awards: Startups to Watch
Summary: Which 11 biotech startups stand out from the pack that have launched in 2020? Watch the Endpoints 11 – Startups to Watch Awards, a virtual event celebrating innovative science and entrepreneurship.
Creating Commercial-ready & Scalable Solutions for Gene Therapy Development & Manufacturing
Summary: Learn about the complexities from raw material supply through drug product manufacturing, including planning early for a commercial-ready process.
Overcoming Scalability Challenges with Autologous Therapies
Summary: In this webinar, Catalent presents a clinical-to-commercial perspective on autologous therapies and the various solutions available for commercial scale-up of advanced therapeutics
Keys To A Successful Rapid Commercial Launch
Summary: Learn how to invest adequate time and resources in strategic planning and preparation activities to ensure the best chances for a successful commercial launch.
How COVID-19 Is Bending the Curve on Vaccine Development and Manufacturing Norms
Summary: Hear Catalent Biologics Region President, address challenges in manufacturing scale-up and discuss how partnerships are enabling pharma companies of all sizes to meet unprecedented timelines as they race toward delivering vaccines to patients worldwide.
N-Glycosylation Analysis Using MassLynx, BiopharmaLynx, and UNIFI™
Summary: Download this webinar to hear various approaches to generate batch comparability results for a biosimilar glycoprotein and vaccine candidate
Novel SMARTag® Bioconjugation Technology Enables Better-Tolerated ADCs
Summary: Download this webinar to learn how our RED-106 noncleavable maytansine linker-payload is well-tolerated, offering wider therapeutic windows compared to other technologies.
Cell Line Development Using the Beacon® Platform
Summary: Learn why speed and efficiency are top priorities for companies looking to develop a clonal cell line for drug substance manufacturing.
Overcoming Commercialization Challenges for Cell & Gene Therapies
Summary: This panel discussion highlights technical and regulatory hurdles associated with development and manufacturing steps, and strategies and solutions to facilitate development through commercialization.
GPEx® Boost: A Novel Approach for High-Expressing CHO Cell Line Engineering
Summary: This webinar describes GPEx Boost technology in detail and discusses case study comparisons.
BFS Solutions for Inhaled and Biologic Therapies
Summary: In this eBook, learn about the development of respiratory and ophthalmic therapies and considerations for container types, with a focus on complex and biologic formulations.
How COVID-19 Is Reshaping Vaccine Development: Innovations in Technology & Manufacturing Partnership
Summary: Experts provide an update on their partnership to enable and expedite scale-up to large-scale manufacturing and how it can be applied to future vaccine development.
Enabling Success in Biologic Drug Substance Development and Biomanufacturing
Summary: Biologic drug substance development and biomanufacturing is a critical step in the long, complex pathway to approval. There are many considerations to be made around…
Clinical Readiness – Practical and Innovative Solutions for AAV Development and Manufacturing
Summary: Learn about specific case studies for neuromuscular degenerative indications, AAV technology and manufacturing, strategies for navigating the current regulatory environments.
Allogeneic T-Cell Therapies: Efficient Commercial Manufacturing Readiness Using “Manufacturing by Design” Methodology
Summary: Allogeneic T-cell therapies are moving towards having breakthrough therapies available for market launch.
Catalent Cell & Gene Therapy, the Journey
Summary: Learn about Catalent’s journey into the Cell and Gene therapy space, overcoming challenges, and the company’s commitment to its partners.
R&D Leadership During the Pandemic
Summary: R&D execs discuss how they’ve reorganized global teams, tapped new programs to fight COVID-19 and plan for the future after the pandemic.
Endpoints Cancer R&D Summit: The Outlook for Cancer Gene Therapies
Summary: What hurdles need to be overcome before gene therapy is the new modality in the cancer therapy arsenal? We’ll look at manufacturing, viral vectors, and the most promising approaches coming to the clinic.
ASCO Postview: Highlights from the 2020 Virtual Conference
Summary: Experts and executives break down the biggest data that came out during the American Society of Clinical Oncology (ASCO) virtual conference 2020.
Radiance® Label-Free Monitoring of AAV Transfection in HEK293 Cells Using Laser Force Cytology™
Summary: Catalent and LumaCyte experts collaborate to compare AAV production with three different transfection reagents.
TRPH-222 Interim Phase 1 Data: Enhancing Safety with SMARTag® Technology
Summary: Maximizing the therapeutic window and manufacturing well-defined ADCs are major challenges in the clinical development of ADCs. During this webinar, experts from Triphase Accelerator and…
Achieving Faster Timelines and Higher Titer in Antibody Expression When Combining GPEx® Cell Line Development Technology with the Beacon® Platform for Clonal Cell Line Selection
Summary: This case study explores Catalent’s unique GPEx® technology for stable gene product expression with Berkeley Lights, Inc.’s (BLI) Beacon® instrument for clonal selection.
Achieving Integrated Biologics Development: Challenges and How to Tackle Them
Summary: A comprehensive end-to-end solution from biologics development, clinical to commercial-scale manufacturing and finished product supply has the potential to provide higher…
Drug Manufacturing in a Time of Coronavirus
Summary: The COVID-19 pandemic has roiled R&D plans, created new priorities overnight and generally forced a major shift in many global manufacturing operations. This is an unprecedented…
How to Accelerate Early Drug Development in Oncology For Small Molecules and Biologics
Summary: Get an insight into what it takes to move a pre-clinical drug candidate to a Phase 1 clinical trial. The presentations will provide guidance on non-clinical and regulatory considerations…
Re-engineered Tubing Assembly for iCELLis® Nano Bioreactor
Summary: To minimize off-line manipulations with aseptically-closed bioreactor system, iCELLis® Nano tubing assemblies were designed to use on-line bio-welding technology for each step from…
Comparison Oxygen Mass Transfer Coefficient (kLa) of iCELLis® Nano and iCELLis® 500 Bioreactors
Summary: kLa estimations were performed for the iCELLis® Nano and iCELLis® 500 bioreactors with equivalent packed-bed size and compaction (4m2 and 500m2).
Biologics Analytical Services Stand-alone GMP and Non-GMP Analytical Solutions for Large Molecules
From pre-clinical testing through post-approval release and stability, Catalent provides customized, stand-alone solutions throughout the drug development process.
Strategies for Testing Host Cell Protein
Summary: The FDA requires that host cell proteins (HCPs) be reduced to low levels because they can affect the safety and efficacy of a drug. Pharmaceutical Technology recently spoke with…
A Novel HER2-Targeted Antibody-Drug Conjugate Offers the Possibility of Clinical Dosing at Trastuzumab-Equivalent Exposure Levels
Summary: Trastuzumab and the related antibody-drug conjugate (ADC), ado-trastuzumab emtansine (T-DM1), have treatment indications in both early-stage and metastatic settings for…
Conversion of a Potency Assay from Cell-Based Binding to AlphaLISA
Summary: A relative potency assay was based upon inhibition of a mAb binding to a cell-surface expressed antigen on viable cells and assessed via flow cytometry.
Gene Therapy – Unprecedented Growth and Challenges
Summary: Gene therapy is a rapidly growing area in healthcare but, now the promise has been shown, we must focus on improving the manufacturing process and reducing…
Frontiers in Binding Assays and Bioassays
Summary: Bioassays and binding assays play a critical role in ensuring product quality, safety and efficacy.
The Do’s and Don’ts of Managing a Pivotal Gene Therapy Trial
Summary: Gene therapies have been exploding in popularity and lining up new programs looking to create a new standard of care models for a wide variety of diseases.
From Basics to Best Practices: Exploring Bioassays and Binding Assays
Summary: Analytical testing for biologics is evolving rapidly as new protocols become available and companies seek to expedite current methodologies.
Strategies for Testing Host Cell Proteins
Summary: The FDA requires that host cell proteins (HCPs) be reduced to low levels because they can affect the safety and efficacy of a drug. Pharmaceutical Technology recently spoke…
Infographic: Bioassays and Binding Assays
Summary: Download the infographic to learn more about the latest cell-based bioassays and binding assays with an emphasis on their applications in the industry.
Strategies for Successful Transition of a Biologic Assay
Summary: Patient centricity has always been at the heart of the pharmaceutical industry. With rising costs of drugs and healthcare, there has been…
Quantification and Characterization of Polysorbate-80 in Protein Formulations
Summary: In this article, Luke Deters, Director of Biologics, discusses an appropriate method for quantification and characterization of polysorbate-80 (PS-80), a commonly-used, but highly-heterogenous, surfactant…
Regulatory Support
Summary: Our regulatory team completes over 150 agency submissions each year, supporting all stages of the product lifecycle. We assign a dedicated regulatory professional to each of our clients…
Biologics Development Overview | Why Catalent?
Summary: Our mission is to enable better biologic therapies to get to patients. Through our suite of proprietary technology platforms and range of integrated development, manufacturing and…
Biosimilars | Why Catalent?
Summary: As your strategic partner for Biosimiliar development, our unique technologies and integrated services will help you to get more and better products to clinic, faster…
SMARTag™ Antibody Drug Conjugate Technology | Why Catalent?
Summary: The SMARTag™ Antibody Drug Conjugate technology platform offers ADC developers a new toolkit to develop optimized bioconjugates. Developed by Redwood Bioscience…
SMARTag Technology: Better Conjugates
Summary: Jennifer Mitcham describes how Catalent’s SMARTag technlogy combines the targeted binding specificity and half-life benefits of monoclonal antibodies with the potency advantages…
What are the latest developments for SMARTag ADC technology?
Summary: Antibody drug conjugates (ADCs) combine the targeted binding specificity and half-life benefits of monoclonal antibodies with the potency advantages of small molecule…
Catalent Biologics | Cell Line Development
Summary: Your Strategic Partner for Biologics Development & Supply. As your trusted partner for tailored biologic solutions, we can help to bring your product…
Catalent Biologics | Downstream Processing
Summary: Your Strategic Partner for Biologics Development & Supply. As your trusted partner for tailored biologic solutions, we can help to bring your product…
Catalent Biologics | Analytical
Summary: Your Strategic Partner for Biologics Development & Supply. As your trusted partner for tailored biologic solutions, we can help to bring your product…
Catalent Biologics | Upstream Development
Summary: Your Strategic Partner for Biologics Development & Supply. As your trusted partner for tailored biologic solutions, we can help to bring your product…
Careers at Catalent Biologics
Summary: Catalent Biologics is a rapidly growing piece of our business. Learn what our employees are saying about what it’s like to work at Catalent Biologics.
Take Your Biologic to Clinic or Market, Faster
Summary: Biologic therapies are transforming the treatment of disease and improving the lives of millions. We have the passion to help you accelerate, simplify and de-risk…
GPEx® Boost: The Next Generation of Cell Line Development
Summary: GPEx® Boost is the next generation of cell line development, designed to improve productivity by leveraging proven GPEx® technology with multiple enhancements, including utilization of a glutamine synthetase…
OneBio Suite: Integrated Biologics Development, Manufacturing and Supply
Summary: OneBio™ Suite provides integrated biologics development, manufacturing and supply with a single solution from cell line development through clinical supply. OneBio Suite is designed…
A Brief Evaluation of the Impact of Thermal, Shear, and Light Stress on Adalimumab
Summary: The propensity of a protein to degrade under stress can vary widely among proteins and is important to understand in pharmaceutical development. A model protein, adalimumab, was tested by a limited…
Multidimensional Evaluation of mAb Degraded Under Light, Shear and Thermal Stress Conditions
Summary: This poster evaluates the degradation of a therapeutic mAb, Adalimumab, resulting from light, shear and thermal stress. Degradation was evaluated using a combination of Sedimentation…
You’ve got that coveted accelerated regulatory pathway. Now what?
Summary: While everyone wants a Breakthrough Therapy Designation (BTD), Fast Track or PRIME, these designations also add to the pressure of getting a drug to the clinic under tight timelines….
GPEx® Boost – A Novel Approach for High-Expressing CHO Cell Line Development
Summary: Pharma companies are always examining ways to increase efficiencies and reduce cost of drug development. While cost of goods sold (COGS) can be…
Planning a Rapid Commercial Market Launch for Your Biologic
Summary: Planning a commercial launch of a biologic into the market is key to its success. In certain instances, there may be a need to get to market much faster than…
GPEx® Boost Technology
Summary: Achieve higher titers by leveraging the power of proven GPEx® Technology with a glutamine synthetase knockout CHO cell line.
High-Throughput Preformulation Development Platform for Biologics
Summary: Typically, in early development, the quantity of protein available for studies is limited, and a dataset is required to expedite Tox- and IND-enabling stability studies. In this study, a high-throughput formulation development…
Rapid Global Characterization of Immunoglobulin G1 Following Oxidative Stress
Summary: While peroxide and leachable metal-induced chemical modifications are among the most important quality attributes in bioprocess development, there is no mainstream characterization method covering all common…
Analytical Quality by Design Using Design of Experiments
Summary: At the center of analytical Quality by Design (QbD) is Design of Experiment (DoE). Using DoE, assay development begins with the creation of an analytical target profile to define method objectives including critical method…
Embarking Upon the Commercial Manufacturing Journey For a Biologic: Strategies to Achieve Successful Approval & Launch
Summary: There are several key considerations to how sponsor companies should approach commercial-scale manufacturing that may aid the success of their product’s commercial launch. In some cases, there is a need to identify…
A Strategy to Standardize Process Characterization & Late Phase Development – Cell Culture Optimization
Summary: Process characterization is an important step in the overall journey of product development. For therapies that have had early success in the clinic and are progressing toward commercial
From Basics To Best Practices: Exploring Bioassays And Binding Assays
Summary: Biologics analytical testing is rapidly evolving as new testing protocols become available and companies seek to expedite current methodologies. Learn about the latest cell-based…
How to Choose the Best Partner for Biologics Development and Manufacturing
Summary: Biologic development is complex, requiring a significant amount of time and resources to ensure the best chance of success. Consequently, there are numerous aspects…
Biologics Brochure
Summary: Explore our suite of proprietary technology platforms and range of integrated development, manufacturing and clinical supply services. Catalent Biologics partners with leading biologic and…
Early Phase Solutions Brochure
Summary: Explore the advanced drug development services to get you products to market faster. A toolkit of superior technologies to overcome all your molecule’s challenges…
OneBio® Suite
Summary: OneBio™Suite is a single solution integrating development through complete clinical and commercial supply to simplify, accelerate and de-risk…
How to Choose the Best CDMO Partner for Your Biologic Development
Summary: Many, if not most, small and midsized biopharma companies choose to partner with outside vendors—contract development and manufacturing organization, or CDMOs—to handle their end-to-end biologic…
Development Of An Intensified Fed-Batch Process Utilizing N-1 Perfusion And Ambr®15
Summary: While traditional fed-batch bioreactor process development has been well defined using methods such as shake flasks and bench-scale bioreactors, there is a desire to intensify…
Strategies For Speeding Time To Clinic For Biotherapeutics
Summary: As the need for accelerated biopharmaceutical development around the world continues to grow, companies are facing complex challenges that need to be overcome to remain competitive for increasing process productivity…
Beating the Clock – Case Studies in Expediting Biologic Development
Summary: Biologic drug development is complex, requiring broad capabilities and expertise to ensure the highest likelihood of regulatory approval and commercial success. The journey from cell line development…
Avoiding Delays on the Pathway to Clinic
Summary: Time is of the essence in the biopharmaceutical industry. How can developers ensure they get to the clinic as efficiently and smoothly as possible?
Rapid Global Characterization of Immunoglobulin G1 Following Oxidative Stress
Summary: In this whitepaper, we describe a method for rapid and consistent global characterization of leachable metals- or peroxide-stressed immunoglobulin (Ig) G1 monoclonal antibodies (mAbs).
Biophysical Characterization of a Therapeutic mAb and its Associated Antigen-Binding Fragments
Summary: Changes during purification, formulation, fill-finish, and distribution can affect protein stability and practically all steps in the manufacturing process may perturb the higher-order structure and heterogeneity of the molecule…
Development Strategies for Difficult to Express Proteins
Summary: Biopharmaceutical products in development continue to increase in complexity. These include numerous multi-specific antibody platforms, proteins that require cleavage, or other additional post-translational modifications…
Achieving a Successful Drug Product Technology Transfer
Achieving a Successful Drug Product Technology Transfer Summary: Technology transfer is a challenging and multi-faceted endeavor, with multiple variables that must be carefully considered. Get insights on key considerations for a successful process transfer for...
Getting Your Biologic To Clinic Faster And More Efficiently
Summary: There are multiple opportunities for companies to speed time to clinic, which impacts the speed to…
Achieving Unique Synergies In Antibody Expression
Summary: Shortening timelines to generate more productive, stable and high expressing cell lines is the goal of any cell line development…
How To Get The Most Out Of Your Phase I Biologic Study
Summary: A new wave of biologics in the clinic has forced companies to rethink how they execute Phase I studies. In this webinar, a panel of…
Case Studies in Expediting Biologic Development
Summary: Biologic drug development is complex, requiring broad capabilities and expertise to ensure the highest likelihood of regulatory approval and…
Accelerated Development Through Strategic Analytical Partnerships
Summary: Learn about the new strategy model for outsourcing – When two or more parties begin with a candid, transparent, and well thought-out process to full…
ADCS – The Dawn Of A New Era?
Summary: The technology behind antibody-drug conjugates (ADCs) has been around for many years, but key learnings in the clinic have furthered our understanding…
Complex Protein Production
Summary: Download the eBook to learn about innovative products and techniques for scale-up of complex biologics, get optimal cell culture medium and feed to maximize…
Planning Successful Launches Of Complex Drug Products
Summary: Developing and bringing a new drug to market is a long, expensive, and uncertain process. It’s even more complicated when it comes to complex products…
Integrated Solutions for Biologics Formulation and Drug Product Development
Summary: There are many challenges to conduct thorough drug product formulation development at early stage drug substance process development. Those challenges include…
Evaluation of the 3M™ Emphaze™ AEX Hybrid Purifier
Summary: The 3M™ Emphaze™ AEX Hybrid Purifier is a novel purification tool that utilizes a Q-functional hydrogel and 0.2 μm membrane to reduce impurities…
A Strategy to Remove Formulation Development from the Critical Path
Summary: During this Q&A, Dr. Jun Lu, Director, Analytical Development at Catalent discusses how Catalent utilizes automation, specifically the UNcle® platform*, during formulation development…
Biologics Development Infocard
Summary: Catalent Biologics provides comprehensive services to meet complex biologic development needs. Click to see our global locations and services…
Critical Steps For A Successful Tech Transfer
Summary: Contract development and manufacturing organizations (CDMOs) occupy a unique position in the pharmaceutical industry. They have the great opportunity of being able to…
Biomanufacturing Infocard
Summary: Catalent Biologics’ two state-of-the-art facilities have been designed to provide integrated bulk drug substance for clinical trials and commercial launches.
Step-wise strategy to address process characterization and late phase development – toward the definition of a standardized approach
Summary: In this poster, scientists at Catalent Biologics propose a stepwise approach for the definition and execution of process characterization for the…
Developing a High-Throughput Formulation Development Platform for High-Concentration, Therapeutic Monoclonal Antibodies
Summary: In this poster, scientists at Catalent Biologics outline a method utilizing a high-throughput, micro-well plate platform to economically screen a mAb in 96 formulations…
ICP-MS Analysis of Multiple Trace Elements in Industrial Cell Lines
Summary: In this poster, Catalent Biologics outlines a strategy using inductively coupled plasma-mass spectrometry (ICP-MS) to conduct trace-level multiple analysis…
Trends in Biologics Manufacturing from Drug Substance to Fill/Finish
Summary: The biologics industry is growing rapidly with an estimated 40% of biopharmaceuticals in the industry pipeline. Consequently, pharmaceutical companies are strategically…
Systematic LC/MS/MS Investigations for the IND-Enabling Extended Characterization of Antibody–Drug Conjugate Modifications
Summary: ADCs are an important class of biologic drugs that are well-represented in clinical trials for oncology and other indications. These medicines harbor both…
Implementing the Beacon Platform for the Next Generation of Cell Line Development
Summary: Pharma companies are looking for ways to speed up their biologics to market in order to meet the patients’ needs. During this webinar…
Insights into Process Characterization: Implementation Strategies and Industry Trends
Summary: Watch this webinar to see an overview and case study of process characterization performed by Catalent…
Improving Efficiencies In Biomanufacturing With Formulation Development And Continuous Processing
Summary: Pharma companies are constantly looking for ways to save money within their operations. One way of doing this is to improve upon efficiencies within its manufacturing…
A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations
Summary: Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability…
Comparing Continuous And Batch Processing In Downstream Purification
Summary: Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities…
Continuous Processing in Biomanufacturing: Considerations for Adoption and Case Studies in Biologic Development and Manufacturing
Summary: Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including…
New Techniques for Analytical “Bioassay” Cell Banking
Summary: The creation of a reliable bioassay requires dependable master and working analytical cell banks. In this interview with Pharmaceutical Technology, Michael Sadick, Ph.D., principal scientist at Catalent Biologics, explains…
Drug Product Manufacturing Infocard
Summary: Catalent can formulate and fill your product into vial, syringe, or cartridge injectable formats that are ready-to-use (RTU) for the patient or healthcare professional.
Device Assembly & Packaging Infocard
Summary: Catalent Biologics’ secondary packaging operations in Belgium, Italy, and the United States offer state-of-the-art, high-speed, automated equipment as well as integrated…
Ensuring Success In Early Biopharmaceutical Formulation Development
Summary: Discover how a pilot formulation study at the early drug substance development stage can make things considerably easier at the manufacturing stage.
Prefilled Syringes & Parenteral Manufacturing
Summary: The global prefilled syringe and parenteral packaging markets are gaining momentum and growing quickly. Key players within the market are focusing their efforts to ensure products are of the highest quality, safe, and easy to use…
Continuous Processing In Biomanufacturing
Summary: As the biologics industry continues to grow, biopharmaceutical companies are evaluating continuous processing as a potential means to improve efficiencies. There are many factors to consider when determining whether continuous processing should be adopted, and if so, what adoption strategy should be used…
Advances in Analytical Technology for Biopharmaceuticals
Summary: As the biologics industry grows, new analytical techniques are being developed to meet changing needs. This ebook discusses advances in analytical techniques for biopharmaceuticals.
An Emerging Playbook For Antibody Drug Conjugates: Lessons From The Laboratory & Clinic Suggest A Strategy For Improving Efficacy And Safety
Summary: Antibody drug conjugates (ADCs) have become de rigueur for pharmaceutical oncology drug development pipelines. There are more than 40 ADCs undergoing clinical trials and many more in preclinical development…
The Next Step In Homogeneous Bioconjugate Development
Summary: Bringing a new biologic drug to the market is a long and expensive process with R&D cycles that can span more than 15 years and cost over a billion dollars. Nonetheless the pharma industry is increasingly shifting efforts to focus on these types of compounds…
ADC Development Using SMARTag™ Technology
Summary: Bioconjugates are an emerging class of biologics that combine the favorable properties of proteins, such as specificity and the ability to target distinct protein interfaces, with the advantages of synthetic small molecules, such as potency, bioavailability, and synthetic tractability. Early examples of bioconjugates include proteins linked to…
Reconstitution Of Formylglycine-generating Enzyme With Copper(II) For Aldehyde Tag Conversion
Summary: To further our aim of synthesizing aldehyde-tagged proteins for research and biotechnology applications, we developed methods for recombinant production of aerobic formylglycinegenerating enzyme (FGE) in good yield…
Innovative Strategies To Maintain Product Integrity In Biologic And Biosimilar Clinical Studies
Summary: Delays encountered during clinical studies can have a serious impact on competitive advantage, speed to market and the availability of lower-cost alternatives for patients. Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and…
Designing Optimized, Site-Specific ADCs
Summary: Antibody-drug conjugates have provided a breakthrough in targeted medicines but ways of increasing their stability and efficacy are still required. Historically, the technologies used to build these two approved products result in a heterogeneous milieu of conjugates…
Viral Clearance For Biopharmaceutical Downstream Processes
Summary: Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals. These studies are a key component of risk mitigation to reduce the potential for iatrogenic transmission of pathogenic viruses. This paper reviews regulatory guidance and practical strategies for designing viral clearance studies…
Generating Aldehyde-Tagged Antibodies
Summary: This article is a selection of articles published in BioMed Central Ltd., giving overview on the ability to site-specifically conjugate a protein to a payload of interest has found widespread application in basic research and drug development…
New Ideas For Antibody-Drug Conjugate Design
Summary: This article is a selection of articles published in The Scientist, giving overviews on new ideas for antibody-drug conjugates designs so oncologists can aim a chemical payload at any cell for which they can identify a specific antigen, such as the HER2 receptor on breast cancer cells…
Enabling Higher Post Protein A Product Purity Using Novel Chromatographic Clarification
Summary: In the recent years, multiple optimizations and advances have been made to the classic antibody generation process to make it scalable, reproducible, and commercially viable. This article describes a strategy to get consistent highly pure products…
What Role Do Biologics Play In The Fight Against Disease?
Summary: Jennifer Mitcham, SMARTag™ business development, Catalent Biologics, offers insight into the new generation of antibody drug conjugates and the increasing importance biologics play in the fight against disease…
Optimizing Titer And Use Of A Specific Enzyme For Generating A Fully Processed Antibody
Summary: In Biologics, the market climate requires increasing speed to move the product to the next phase of development. Even before a product is proven effective in clinical trials, several decisions must be made…
Get To Clinic Faster: Navigating Complex Biologics Through Development And Manufacturing
Summary: In Biologics, the market climate requires increasing speed to move the product to the next phase of development. Even before a product is proven effective in clinical trials, several decisions must be made…
Novel Analytical Techniques For Monoclonal Antibodies
Summary: With the rising interest in biopharmaceuticals, drug developers need to quickly understand and evaluate the binding of therapeutic antibodies to Fc receptors. In this interview with Pharmaceutical Technology, Michael Sadick, Ph.D., and Dan Papa, Ph.D., of Catalent Biologics, talk about a new analytical testing panel…
Biopharma Manufacturing Trends
Summary: As pharma companies look more and more to biologics for their next potential blockbusters, they must face the challenges surrounding these products’ scientific complexity and sophisticated development…
Antibody-Drug Conjugates – Where Are We Now?
Summary: In October 2015, during CPhI World Wide in Madrid, Spain, Oncology Tube from InPress Media Group, LLC. asked experts from Piramal Pharma Solutions, Carbogen Amcis and Catalent Biologics about challenges in the manufacturing of ADCs and how they see the market for ADCs evolve…
Accelerating Method Transfer: Effective Automation Of Biological Assays
Summary: Bioassay automation offers ergonomic relief for scientists, consistent method execution, increased throughput, and reduced full-time equivalent expenditure. Importantly, successful automation programs allow unparalleled efficiency in method transfer to receiving laboratories. oderated Q&A roundtable…
The Ever-increasing Attraction of Biologics
Summary: The field of biologics promises targeted treatments for a range of conditions. For the promise of many of these therapies to become a reality, however, technological challenges must still be overcome, with many exciting novel treatments currently on, or making their way to, the market. This article published in Chemistry World discusses…
Contractors Take On The Challenge Of Complex Molecules
Summary: The global pharmaceutical analytical testing outsourcing market could reach ~$10 billion in the next decade. Read the latest Drug Development & Delivery report highlighting how the leading service providers are prepared to provide analytical and bioanalytical methods that address the growing market…
Moving A Complex Protein From Development To Large-Scale Clinical Production
Summary: The number of more complex biopharmaceuticals in development continues to increase. These include molecules like virus-like particle vaccines, proteins that require cleavage, or other additional post-translational modifications not typically performed by CHO cells, and more recently, numerous different multi-specific antibody platforms…
Single-Use Bioreactors Pose E&L Challenges
Summary: Read the recent roundtable Q&A published in BioPharm International featuring biopharma executives discussing the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process…
Accelerating Biologics And Biosimilar Development
Summary: Get to know how Catalent’s scientists have utilized ambr 15® as a micro-scale model for a synergistic clonal and process screen to identify the master cell bank candidates. Using this multi-layered approach, early in the development process significantly improves selection of top clones while shortening the overall timeline…
Biosimilars: Getting Cheaper Biologics To The Market
Summary: The opportunity for new antibody biosmilar products is clear. By the end of this decade key patents currently protecting five monoclonal antibodies, each with sales in the neighborhood of a billion dollars a year will have expired, and companies are queuing up for a piece of the market…
Get To Clinic Faster: Navigating Complex Biologics Through Development And Manufacturing
Summary: With the increasing complexity of biologics and growing competition with players ranging from small start-ups to large pharma, an aggressive development timeline is required to bring your biologic drug to clinic faster…
Biopharmaceuticals/ Biosimilars Roundtable, APR 2017
Summary: The biopharmaceutical market has seen incredible growth. American Pharmaceutical Review conducted industry round table with experts to share their opinion on the market drivers for growth, limiting factors and critical issues. Read the article to get insights on developing and marketing biopharmaceutical…
Developing Site-Specifically Modified ADCs Using A Chemoenzymatic Approach
Summary: Antibody-drug conjugates (ADCs) have become de rigueur for pharmaceutical oncology drug development pipelines. There are more than 40 ADCs undergoing clinical trials and many more in preclinical development. This webinar hosted by Elsevier’s Drug Discovery Today presented novel protein modification platform and its application…
Accelerating Biological Assay Method Transfer Through Effective Automation
Summary: Bioassay automation offers ergonomic relief for scientists, consistent method execution, increased throughput, and reduced full-time equivalent expenditure. Importantly, successful automation programs allow unparalleled efficiency in method transfer to receiving laboratories…
Evolution Of Biomanufacturing Facilities
Summary: Advances in single-use bioreactor technologies offer rapid development pathways when combined with creative upstream process development strategies. When aggressive program timelines are required, the application of multiplexed conditions coupled with smart CMC decisions that maximize yields…
Virus Safety Of Biopharmaceuticals: Risk Mitigation During Upstream And Downstream Operations
Summary: From a virological safety standpoint, biopharmaceuticals have had an excellent safety record. This can be attributed to regulatory and industry initiatives that have worked synergistically…
The Challenges And Solutions For Non-invasive Macromolecule Delivery
Summary: Biologic therapy has revolutionized the medical treatment landscape. However, simplicity and ease of administration remains a challenge to achieve long-term patient compliance and optimal therapeutic outcomes. Given the high cost of biologic therapies…
Clinical Trial Supply Strategies For Biosimilar Studies
Summary: The use of biosimilars in clinical trials is on the rise. Often tightly controlled or in short supply, sourcing the necessary drugs can be challenging. Given the variability of biosimilars, studies using these products are particularly at risk for supply-related delay and cost overruns unless proactively managed from the beginning…
Recent Developments In ADC Technology: Preclinical Studies Signal Future Clinical Trends
Summary: The antibody-drug conjugate (ADC) field is in a transitional period. Here, experts from Catalent discuss how pre-clinical work is driving rapid evaluation of how we strategize to improve efficacy and reduce toxicity towards better therapeutic outcomes…
The Perfect Partnership — Looking At The Growing Need For Strategic Partnerships
Summary: Strategic analytical partnerships are important in the development of new pharmaceutical products, especially biologics. Here, Michael Merges, Catalent Biologics, and Brian Fahie, Biogen, discuss the growing need for partners who can provide niche technologies to accelerate development projects…
Optimized Antibody Drug Conjugate Development
Summary: One of the current challenges with existing ADCs is the difficulty in creating conjugates with a uniform drug to antibody ratio and consistent payload placement on the antibody, both aspects which are paramount in creating consistent and predictable therapies…