Biopharmaceutical Product Development July 2009

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 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 provides 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 I and/or Phase II clinical trials in Asia, Australia, South America, the USA, and Europe with the manufacturing occurring at either Catalent’s Middleton, WI biomanufacturing facility or at a 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™ technology 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 that relating to the recent revision of USP 111). 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 extensive experience in recombinant proteins, stem cells, and therapeutic viruses. Our skilled scientists adhere to GLP and closely follow Crystal City guidelines from the preclinical stage through all phases of clinical evaluation.

Biosafety Testing Services: 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/immunogenicity of degradation species, and accelerated stability.

Phase I Sterile Clinical Supply: With over 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 I trials. In addition, we provide aseptic processing and filling, including prefilled syringes, vials, and blow/fill/seal.

A Full Spectrum of Innovative Solutions

Catalent provides the biopharmaceutical 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.