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.
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.
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.
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…
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.
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.
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…
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…
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…
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…
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…
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…
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…
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…
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...
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…