Do Stringent Quality Guidelines Drive BioProcess Design?

The biopharmaceutical industry is, by some definitions, the industry surrounding bioprocessing and the discovery, development and production of small-molecule drugs. These drugs are derived from living organisms as opposed to being chemically synthesized using traditional methods of pharmaceutical companies. Examples of these drugs are proteins such as antigens used for vaccines, or nucleotide oligomers such as the "primer" vaccine for AIDs developed by GeoVax. In March 2008, bioprocessing was said, by jounalists for BioProcess International, to be embarking on a "new era", driven by new "high-level ICH and FDA quality guidelines". The authors also proposed that "the emerging field of systems biology may have arisen at exactly the right time to provide the significant process understanding demanded for" the realization of concepts such as continuous quality verification and real-time release – two procedures that are made extremely complicated by the use of cell cultures for production of small-molecule drugs.

According to BPI, the biopharmaceutical industry is moving, by necessity, towards more efficient operation, meaning companies are striving for process intensification and implementing what is called Operational Excellence (Op Ex). One means of achieving Op Ex is through process analytical technology (PAT). By incorporating in-line, real-time quality testing which gives a definitive indication of product quality, as opposed to testing parameters which are not necessarily directly related (e.g. pH, DO, temperature), companies can expect to significantly reduce process and product variability. This could mean less product being discarded because it doesn't meet specs, translating into significant monetary gains. In that respect, smart business managers can anticipate long-term savings resulting from reduced waste of energy, raw materials and resources. As can also be said for ISO certification, which is not mandatory but has been demonstrated to save companies money in the long run, the benefits derived from pursuing Op Ex are likely more significant factors for driving change than voluntary government guidelines.

_Sources:

Whitford, W. and Julien, C. Toward better biopharmaceutical process design and control. BioProcess International, March 2008. p 4.

Julien, C. and Whitford, W. The biopharmaceutical industry's new operating paradigm. BioProcess International, March 2008. p 6-14.