Christopher Phillips Email & Phone Number

Process Development Direct the activities of for fermentation, purification and pegylation process development, scale up, technology transfer, validation and cGMP manufacturing of the API starting materials and API for Oncaspar® and Adagen®. Successfully developed, scaled up, transferred to European CMO, characterized and validated modernized fermentation, purification and pegylation processes for L-asparaginase in < 3 years. Primarily responsible for design, qualification and management of multiproduct facility (fermentation, cell culture, purification, pegylation, cytotoxics, kilo lab, fill and finish in liquid/lyophilized vials) and equipment for process development, scale up, technology transfer and Phase 1 GMP manufacturing of clinical supplies. Support in house and CMO GMP clinical manufacturing of oligonucleotide API and drug product. Perform due diligence for acquisition candidates and CMO qualification/audits.

Senior Director, Process Development: direct fermentation, cell culture, process development, process characterization, scale up, pegylation and formulation of Enzons existing and new natural and recombinant products. Primarily responsible for third party contract manufacturing activities for approved and clinical products.

manufacturing operations for Adagen® (Pegylated Adenosine Deaminase) and Oncaspar® (Pegylated L-Asparaginase) and NCE's in clinical trials. Direct the activities of Manufacturing Operations, Process Engineering & Validation, Maintenance and Materials Control. Manage site renovations/qualification/validation, contractor and supplier operations for raw materials, intermediates, API and fill and finish manufacturing operations for biologics and small molecule clinical supplies and commercial products. Perform CMC due diligence for acquisition candidates.

Responsible for commercial contract manufacturing of Periostat® 20-mg Doxycycline Hyclatecapsules and tablets for the treatment of periodontal disease. Maintain the supply of commercialproduct in the US and UK. Periostat® project team leader: US and UK commercial capsulemanufacturing and tablet dosage form development, process validation, method validation andcontractor management. Synthesis and scale up of NCE's for clinical trials, contractorqualification, process and analytical method validation; US NDA CMC Section filing andapproval; UK MAA CMC Section filing and approval; successful USP Petition.

Responsible for manufacturing of Periostat capsules/tablest and the development of NCEs

Development, scale up and cGMP manufacturing of drug product for clinical trials. Direct allthird party technical development, synthesis, process development, scale up, formulationsdevelopment, validation, cGMP manufacturing, analytical testing and release, stability and drugdelivery activities for the Company's small molecule (oral solid dosage and lipid encapsulated

Consulting services for small molecules and biologics. Focus on process development, processoptimization, cGMP manufacturing, analytical characterization, formulations (liquids and freeze-dried), stability and drug delivery. Co-developed parenteral liquid formulation for natalizumab(Tysabri®; treatment of multiple sclerosis; annual sales: > $1 billion

Directed the process development and manufacturing activities for the scale up and cGMPmanufacturing of recombinant protease inhibitors isolated from E. coli. Pilot plant design,construction, timelines, budgets and personnel. Head technology transfer and scale up of thepurification/formulation processes from the US pilot plant to cGMP contractors for bulk drug andfinal product manufacturing.

, Immunoconjugates Directed activities of Process Development Group (8 scientists) responsible for the bulk drug purification, radiolabeling, formulation, scale up and cGMP manufacturing process for 90Y-

Supervised the development of processes and formulations for recombinant proteins and pegylated conjugates and radioimmunoconjugates in liquid and lyophilized forms. Developed various lyophilized formulations for protein and small molecules.

Developed purification, conjugation, radiolabeling processes and formulations for therapeutic andin vivo diagnostic monoclonal antibodies for liquid and lyophilized preparations. Development ofpurification, conjugation radiolabeling processes, formulation and analytical methods forMyoscintTM (Fab-DTPA-111In) for in vivo diagnostic imaging in humans.

Supervised the cGMP production of therapeutic monoclonal antibodies for clinical trials. Process scale up/optimization and parenteral formulation development.

Synthesis of acrylic fluorescent nanospheres for cell sorting device applications. Solution phase synthesis of peptide protease substrates and purification and characterization of

Physiological, biochemical and enzymological research on the secondary metabolism of variousplant cell cultures in solid and liquid phases. Thesis title; "The Effect of Nutrient Concentrationson Growth and the Production of Secondary Metabolites in Plant Tissue Cultures."

Supervised the development, scale up, production and purification of - Interferon in 300 literbioreactors and roller bottle facility. Development and optimization of growth andsuperinduction of human fibroblast cells (FS-4) on microcarriers.

Ms, Biology

Bs, Biology