The fields of analytics, bioanalytics, and microbiology continue to be characterised by important developments. Regulatory changes and innovations will either have a direct impact – as with ICH Q14 “Development of Analytical Procedures” or Q2(R1) “Analytical Validation” – or an indirect impact, as with ICH Q12 “Life Cycle Management” or Annex 1 of the GMP Guide. The requirements for data integrity also represent a challenge in the laboratory sector. For cell- and tissue-based products and gene therapeutics, the number of relevant guidelines and guides is also continuously increasing. So far this year, the FDA alone has published six final guidelines and one draft guideline for gene therapeutics. Yet, in the field of microbiology, developments are also continuing to move forward, as, for example, in the pyrogen test with monocyte activation tests (MAT), instead of rabbit tests, or in the field of low endotoxin recovery. Also, many companies are advancing the establishment of alternative microbiological test methods for monitoring, in-process controls, and release tests. This is especially true with regards to the development and production of modern active ingredients and therapeutics on a biological basis. They also provide the foundation for laboratory optimisation, for which the congress will also offer a track.
Together with an exhibition of around 40 suppliers and service providers, PharmaLab offers the unique opportunity to learn about the latest developments, to discuss them with experienced colleagues, and to benefit from the experience of some 60 speakers.