The time-to-market constraints associated with modern drug development restricts the methodologies and reactions that can be used to make an API. In addition, there are also health and safety issues coupled with environmental factors to consider. An ideal reaction would use an innocuous catalyst to convert all of the substrate to the desired product. However, we are far from this ideal situation. A catalytic reaction has many advantages compared with one that uses a stoichiometric reagent: one molecule of catalyst can produce many molecules of product. This decreases the amount of reagent needed, which can have positive consequences for waste and cost.

The scale-up of manufacturing processes to clinical production can be complicated and expensive, with many issues to consider. This article describes some of the common and less obvious pitfalls encountered by biopharmaceutical companies when scaling up protein production processes, and how to avoid them.

Is consolidated distribution the key to combating counterfeit drugs and parallel imports?

A checklist of how to achieve regulatory compliance by validation of laboratory information management systems. Validation costs and cost-effective validation strategies are considered for pharmaceutical manufacturers to validate their systems and maintain a validated state for continued compliance.

Improved feedstream titres are driving a demand for increased downstream processing productivity as manufacturers seek to lower the costs of monoclonal antibodies (MAbs). The unique selectivity of protein A has enabled platform technologies for MAb purification. Platform technologies and chromatography resin improvements can help manufacturers achieve rapid and economical process development and scale-up. A multiprong approach can enable downstream process scientists to enhance productivity.

Understandably, the thought of implementing a closed-loop PAT strategy throughout the global enterprise and for all products can keep pharmaceutical executives awake at night.

While single-use technologies can be used for filtration, storage and at connection points in egg-based vaccine production, their use multiplies in cell-based applications.

Over the past decade, disposable technologies have become a reality in biotech processes. The use of disposables in research and manufacturing allows high flexibility.