Biopharmaceutical Product Development

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Catalent is your strategic partner for biologic drug development success. We create smart, tailored solutions with our novel SMARTag™ antibody–drug conjugation (ADC) technology, our market-leading GPEx® cell line expression system, expanded biomanufacturing capabilities, and integrated development services to help you get better products to market faster.

New SMARTag ADC Technology for Development of Optimized Antibody–Drug Conjugates — Superior Technology for Treatments in Development: Catalent has entered into an exclusive license and comarketing agreement with Redwood Bioscience to offer customers SMARTag advanced site-specific conjugation technology and linker–toxin combinations to develop optimized antibody–drug conjugates. SMARTag technology is a proprietary approach to help develop improved antibody–drug conjugates. It allows for very precise conjugation and optimal release of the therapeutic agent, providing advantages over existing technologies with precise site-specific drug placement and enhanced potency and stability. It provides better safety, efficacy, and regulatory compliance with increased scalability and manufacturability.

Biomanufacturing Center of Excellence

Increasing Flexibility and Manufacturing Scale for Customized Solutions: Our state-of-the-art facility (with single-use systems) offers increased flexibility and manufacturing scale for our customers and expanded mammalian cell line engineering. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in biologics. Key services include

  • Process development focus with extensive non-GMP and GMP experience, laboratories, and support functions

  • Solutions for difficult-to-express proteins

  • Flexible non-CGMP production up to 250 L and CGMP production scale from 10 L to 1,000 L

  • Tailored process development for all mammalian cell lines

  • Expanded GPEx cell line engineering capacity

  • Offerings in biosimilar cell lines

  • Integrated development services to solve your most difficult biologic challenges

  • Extensive implementation of single-use technologies to eliminate cross contamination.

GPEx (Gene Product Expression) Technology

Progressing Your Pipeline Faster: Catalent’s proprietary GPEx technology enables genetic engineering of highly stable, high-yielding mammalian cell lines with unmatched speed and efficiency. Our proven technology has been expressed in more than 400 cell lines, and our clients have products in clinical trials in both the United States and Europe, with manufacturing occurring at either our Madison, WI site or the client’s site. GPEx technology is distinguished by several important benefits.

Efficiency: GPEx technology uses a vector technology that ensures stable transduction of targeted cells, approaching 100% efficiency — eliminating the need for selectable markers and saving time and cost.

Versatility: Almost any cDNA can be packaged into the GPEx® technology retrovector.

Speed: The process results in high-expressing clonal mammalian lines within five months or less

Flexibility: GPEx® technology can deliver non-cGMP protein, clones, or cGMP protein.

Expertise with a Broad Range of Integrated Development Services

Our unique technologies, deep expertise, and proven track record of global regulatory and commercialization execution provides the support to solve your most difficult drug development challenges. Development services include formulation development, custom bioassay development and management, pharmacokinetics/pharmacodynamic and immunogenicity services, assay qualification, biosafety testing services, viral clearance studies, stability studies, biostructural characterization, biosafety analysis, and clinical supply services.

A Strategic Partner for Biologic Development

From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. With over 75 years of experience, we have the deepest expertise, the broadest offerings, and the most innovative technologies to help you get more molecules to market faster; to enhance product performance; and to provide superior, reliable manufacturing and improved results.

Catalent. More products. Better treatments. Reliably supplied.™

About the Author

Author Details
Stacy McDonald is group product manager, biologics, at Catalent Pharma Solutions, 1-888-765-8846; stacy.mcdonald@catalent.com; www.catalent.com.

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