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…
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...
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’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…
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…
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…