Biopharmaceutical Product Development July 2008

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.

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. It has been used around the world to produce material for clinical trials and offers many important benefits including:

Expanding Capacity to Support Worldwide Demand: Catalent plans to more than double our bioreactor capacity by the end of 2009 to support increased production for clinical trials across Asia, Australia, Europe and the United States.

Custom Bioassay Development and Management: Catalent’s bioassay scientists are recognized industry experts with extensive regulatory expertise (including the recent revision of USP 111). With unparalleled clinical proficiency and advanced technological resources, we can custom-design an optimized bioassay for every type of biologic product — and expedite the validation.

Pharmacokinetics/Pharmacodynamic and Immunogenicity Services: Catalent offers a diverse range of PK/PD and immunogenicity methods in complex biological matrices, 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 non-recombinant 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 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 1 Sterile Clinical Supply: With more than 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, vial and syringe filling, sterile liquid product and lyophilized product services.

A Full Spectrum of Innovative Biopharmaceutical Solutions: Catalent is truly a full service provider. We offer unmatched expertise across a full spectrum of services and technologies, from conceptual design and development to drug delivery, manufacturing and packaging.

Catalent provides the biotechnology industry with an unparalleled range of integrated product development services — with a commitment to better healthcare backed by the intellectual capital and infrastructure of our organization.