Technology Transfer and Scale up of Large Scale bio-processes

Many innovative start up’s have neither the experience nor capital to invest in an own bio-manufacturing plant. Before commercial launch product is required for application testing, pre-clinical testing, clinical trials or market sampling. Often it is required to produce this by a representative process. A sound manufacturing approach can be an essential part of the valuation of a startup company.

Often the only way to develop such an approach is to build a relation with a CMO (custom manufacturing organization), which can be a risky and expensive process.

Critical parts of CMO fit assessment are fermenter sizing, down-stream fit, cGMP and food grade qualifications and professional capabilities.

The general project phases in the relation with a CMO will be described.

Success of this CMO relation may make or break a startup company. Adequate resources, Stage gate project management, risk management are essential for success.

In this process “scale up from lab” meets with “scale down from full scale”. An overall technology process package needs to be developed. Process design may be adapted based upon time line and capital constraints.

Individual unit operations require more than lab development such as: fermentation, most cell separation technologies, membrane processes and drying. Examples will be provided.

A pilot plant organization can be an essential intermediate step providing: Proof of concept for new funding, independent and critical know how, better economics of intermediate project phases, faster timelines, and more flexibility in possible unit operations.