Author Archives: Patrick Nieuwenhuizen

Managing Complex Considerations with Pharmaceutical Facility Design

Delivering safe and effective therapies starts in facilities that are built and maintained with safety and compliance in mind. US Food and Drug Administration (FDA) and European Commission (EC) regulations often are presented as broad guidelines that describe what manufacturers need to account for, but they are not always prescriptive because facilities have unique needs. In a September “Ask the Expert” webinar, Gerardo Gomez and Patrick Nieuwenhuizen of PharmaLex Solutions demystified the guidelines that bioprocessing companies should follow. The Presentation…

Focus on Aseptic Processing: A Report from the September 2022 PDA Annex 1 Event in Amsterdam

The European Medicines Agency (EMA) was true to its word in 2022. While pharmaceutical companies involved in manufacturing sterile products were assessing the text of Draft Revision 12 of Annex 1 to the European Union’s good manufacturing practice (GMP) regulations, the final approved revision was published on 25 August 2022 (1), bringing an end to speculations about what it would include. The Parenteral Drug Association (PDA) has organized a series of four workshops, the third of which took place in…

Aseptic Considerations in Formulation, Fill and Finish: Choosing Between Barrier and Isolator Technologies

Biological drug substances are constituent in a wide range of medicinal products with an even broader spectrum of applications. Those include autoimmune-disease treatments (e.g., for arthritis), vaccines, and recombinant therapeutic proteins (e.g., for cancer treatment). What such products all have in common is that they are manufactured using biotechnology and other cutting-edge technologies. Biologics are not as physically robust as their small-molecule counterparts. Hence, during biomanufacturing processes, these complex molecules present a number of challenges. Some of the typical shared…