Kent has written CMC sections of IND, CTX, MAA and BLA submissions and pre-submission briefing documents. In addition to supporting the drafting of these documents, Kent offers CMC planning support, including:

• Identification and assessment of CMC composition requirements and strategic options
• Process validation planning and assessment
• Participation in communications with FDA and other regulatory authorities

Kent has developed and implemented global supply plans for development-stage and commercial biopharmaceuticals. Kent offers planning and assessment services including:

• Identification and comparative assessment of process format and sourcing alternatives
• Projected capital and operating costs and timelines
• Production capacity and inventory planning
• Identification of risks and opportunities regarding regulatory compliance, operating costs and process robustness and reliability

Kent has participated in the design, construction management and commissioning of 8 biopharmaceutical production facilities, 3 of which are licensed by FDA for commercial production. Kent's services regarding biopharmaceutical facility design and construction include:

• Development of process models and Process Flow Diagrams
• Specification and selection of bioprocess equipment; development of Requests for Proposal
• Development of facility layout, flow and operation concepts
• Support of Factory Acceptance Testing, Site Acceptance Testing and equipment validation
• Start up support, troubleshooting and procedural optimization (steam sterilization, clean in place, fermenter and tangential flow filtration processes)

Kent has led contract manufacturing relationships as a senior representative of a contract manufacturer and as a senior representative of client companies. Kent led Immunex's brief, but successful foray into contract manufacturing in 1995; during the first full year of the program, $6.5MM of new business was generated. Kent has led the development and management of contract manufacturing relationships from the client side as well, working with CMOs in Canada, the US and Europe to support clinical and commercial biopharmaceutical production. Kent offers the following services in support of contract manufacturing:

• Strategic guidance and assessment regarding the structure of contractual terms in contract manufacturing agreements
• Selection of CMOs
• Optimization of contract manufacturing operations and pricing
• Conflict resolution in contract manufacturing relationships

Kent's main areas of technical experience are in fermentation and recovery process optimization and troubleshooting. Kent has experience with the following types of bioprocesses:

• Recombinant mammalian cell culture (up to 10,000 L)
• Recombinant yeast (Pichia and Saccharomyces) fermentation (up to 2,000 L)
• Recombinant bacterial fermentation (E. coli and other; up to 10,000 L)
• Radiolabeling of antibodies
• Clarification by centrifugation and tangential flow filtration

• Resolution of N-terminal heterogeneity in S. cerevisiae-expressed recombinant protein via fermentation media development
• Identification and implementation of viral inactivation step for product sensitive to low pH
• Implementation of tangential flow filtration step in place of centrifugation to increase yield of soluble intracellular E. coli-expressed protein
• Optimization of purity of E. coli-expressed protein via implementation of improved clarification step
• Increase in yield of CHO-expressed protein via implementation of higher performance seed train

Kent also has experience with process chromatography, formulation and filling, and biopharmaceutical analysis and characterization.

Kent has supported due diligence assessments regarding CMC and supply issues as part of biopharmaceutical licensing transactions, and corporate mergers and acquisitions. Kent has served as a technical leader and senior representative in inter-organizational joint development partnerships and post-merger integration planning teams. Kent has experience in the following areas of product licensure and corporate merger support:

• Assessment of CMC development status and projection of costs and timelines to commercialization
• Projection of cost of goods
• Post merger integration and restructuring of manufacturing and process development functions
• Structuring and implementing partnering agreements regarding CMC responsibilities and third party interactions