From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. With over 80 years of experience, we have the deepest expertise, broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and improved results. Catalent is your strategic partner for biologic drug development success.

SMARTag™ ADC Technology for the Development of Optimized Antibody–Drug Conjugates: Catalent has 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 proprietary technology can help the development of improved ADCs. It allows for precise conjugation and optimal release of the therapeutic agent, and can provide

• precise, site-specific drug placement
• enhanced potency and stability
• better safety, efficacy, and regulatory compliance
• increased scalability and manufacturability.

Biomanufacturing Center of Excellence: Our state-of-the-art facility uses single-use systems to increase flexibility and manufacturing scale for customers, as well as expanded mammalian cell line engineering. We offer a broad range of integrated formulation and analytical services to solve your most difficult biologic development challenges. 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-GMP production up to 250 L and GMP production scale from 10 L to 1,000 L
• tailored process development for any mammalian cell line
• expanded GPEx® (gene product expression) cell line engineering capacity
• biosimilar cell lines
• integrated development services for difficult biologic challenges
• extensive single-use technologies to reduce cross-contamination risk.

GPEx Technology: 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 over 400 cells lines, and our clients have products in clinical trials in the United States and Europe, with manufacturing occurring at Catalent’s Madison site or at the client’s site. GPEx technology is distinguished by several important benefits.

Efficiency: GPEx technology uses a vector approach to ensure stable transduction of targeted cells, approaching 100% efficiency, thereby eliminating the need for selectable markers, which saves time and cost.

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

Speed: Use of GPEx technology can result in high-expressing, clonal mammalian lines in five months or less.

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

ADVASEPTâ„¢ Advanced Aseptic Processing is an advanced aseptic filling solution for parenteral products. It provides a glass-free primary packaging container that reduces and even eliminates some of the concerns associated with traditional glass vials. ADVASEPT technology eliminates glass particulates and surface delamination. It reduces foreign particulates by orders of magnitude and decreases protein surface interaction while reducing breakage and container weight for transportation/disposal with an ultrapure plastic design.

Expertise with a Broad Range of Integrated Development Services: Our unique technologies, deep expertise, and proven track record of global regulatory commercialization execution provide 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
• clinical supply services, including cold chain.

Catalent. More products. Better treatments. Reliably supplied.â„¢

Stacy McDonald is group product manager, biologics, at Catalent Pharma Solutions,14 Schoolhouse Road, Somerset, NJ 08873; 1-888- SOLUTION (765-8846), solutions@catalent.com, www.catalent.com.