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
Biologics Analytical Services Fact Sheet
Summary: Stand-alone GMP & non-GMP analytical solutions for large molecules.
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…
Biologics Analytical Services
Summary: Stand-alone GMP & non-GMP analytical solutions for large molecules.
OneBioSM
Summary: OneBioSM 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...
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’s packaging operations in Bloomington, IN, Brussels, Belgium, and soon to include Anagni, Italy offer state-of-the-art, high-speed, automated equipment as well as integrated packaging solutions to support both…
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 & Parental 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…