Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Biopharmaceutical production

Project manager for a medium sized biotech

The services of BioVentures Consulting Limited were requested by the Managing Director of a dedicated biological manufacturing plant, following a successful prior working relationship at a previous company. The re-engaged services were to manage the tech transfer of the primary manufacturing process from an off-site facility into an in-house dedicated biological products manufacturing plant. Activities included gap analysis, characterisation, development, IQ, OQ, PQ and validation studies necessary to define a consistent API production process; and secondary manufacturing for a biological neurotoxin product. The result of the 14-month assignment was a successful tech transfer process and establishment of a consistent in-house manufacturing capability.

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