Biopharmaceutical Product Development July 2010

Catalent Pharma Solutions offers a total solution for the development and manufacture of biopharmaceutical and sterile products. Our proprietary technology — and expertise in working with proteins, peptides, and other biotechnology-derived active materials and small molecules — helps to maximize the potential of your API and accelerate your product’s speed to market. From cell line engineering to manufacture of API and drug product for clinical trials, our team of highly experienced protein chemists, biochemists, pharmacists, and pharmaceutical scientists provide the exceptional service, focus and expertise that your project needs.

GPEx® Technology

Setting a New Standard in Mammalian Cell Line Engineering and CGMP Manufacturing: Catalent’s proprietary GPEx® (Gene Product Expression) technology enables genetic engineering of highly stable, high-yielding mammalian cell lines with unmatched speed and efficiency. More than 150 different antibodies and antibody fusions and more than 40 different recombinant proteins have been produced using the GPEx® technology. Proteins expressed by cell lines produced using the GPEx® technology are in phase 1 and/or phase 2 clinical trials in Asia, Australia, South America, the United States, and Europe with the manufacturing occurring at either Catalent’s Middleton, WI biomanufacturing facility or at the client’s site.

The GPEx® technology is distinguished by several important benefits including efficiency (GPEx ® technology uses a retrovector technology that ensures the 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 (results in high expressing, clonal mammalian lines in five months or less), and flexibility (can deliver non-CGMP protein, clones, or CGMP protein).

Catalent’s new proprietary codon optimization technology, Triplet-Fix™ technology, improves mammalian cell line production and subsequent antibody and protein yield. the triplet-Fix™ technololgy eliminates problems observed in traditional codon optimization technologies by using “natural” DNA sequences spliced together to create a final optimized expression sequence. GPEx® and triplet-Fix™ technologies work together to provide the most efficient and high-quality approach to mammalian cell line development.

GPEx® Technology Biosimilar Feasibility Program: Under this new program, Catalent offers clients a portfolio of cell lines for expressing biosimilar recombinant proteins or the option of contract development of high-producing mammalian cell lines for expressing biosimilars, together with expanded characterization capabilities.

Other Services

Custom Bioassay Development and Management: Catalent’s bioassay scientists are recognized industry experts with extensive regulatory expertise (including USP <1033> and <1034 > ). We can custom-design and optimize a bioassay for almost every type of biologic product — then expedite the validation.

Pharmacokinetics/Pharmacodynamic and Immunogenicity Services: Catalent offers a diverse range of PK/PD and immunogenicity methods in complex biological matrices along with our extensive experience in recombinant proteins, stem cells, and therapeutic viruses. Our skilled scientists adhere to GLPs and closely follow Crystal City/EMEA/FDA guidelines and industry white paper recommendations from preclinical through all phases of clinical evaluation.

Biosafety Testing: Catalent’s biosafety testing services bring added value to every phase of biopharmaceutical development, including custom viral clearance studies for recombinant and nonrecombinant protein therapeutics.

End-to-End Formulation Development: Catalent understands that successful development is a combination of good science, GMP compliance, and regulatory know-how. We offer full service and support for almost every aspect of the process, including method qualification and validation; container/closure selection; lyophilization cycle development; evaluation of aseptic processes; identity, toxicity, and immunogenicity of degradation species; and accelerated stability.

Phase 1 Sterile Clinical Supply: With >25 years of industry- leading experience manufacturing clinical trial materials, Catalent can respond quickly to client needs around the world. We offer complete project management services to ensure precise handling of small- or large-scale batches, facilitating rapid entry into clinics for earlier phase 1 trials. in addition, we provide aseptic processing and filling, including prefilled syringes, vials, and blow/fill/seal.

A Full Spectrum of Innovative Biopharmaceutical Solutions: Catalent provides the biotechnology industry with an unparalleled range of integrated product development services — with a commitment to better health care backed by the intellectual capital and infrastructure of our organization.

About the Author

Author Details
Philip Pratten is director of business development in bio-technology for Catalent Pharma Solutions, Frankland Road, Blagrove, Swindon, SN5 8YG; [email protected]