A GMP for R&D?

The World Health Organisation published a new draft guideline on Good Manufacturing Practice (GMP) for development batches. WHO indicates that this will become the first GxP guidance for R&D.



The main focus of the document is on pharmaceutical formulation and development, general research and development, production of investigational medicinal products (IMPs) and pilot scale batches.



The guidance also covers process validation; cleaning procedure development; cleaning validation studies; as well as stability studies, in relation to development batches. Also, development, validation and transfer of manufacturing processes and analytical procedures.



 

The document also indicates that:

1. The validation of R&D processes (which comes under “process design”), needs to cover the design of experiments (DoE), process development (ICH Q8), the manufacture of products for use in clinical trials, pilot-scale batches and transfer. 
   
2. Analytical R&D procedures should be appropriately recorded and validated (ICH Q14). As the procedures are usually intended to be transferred to QC units in manufacturing facilities of commercial batches, procedures and records should be sufficiently detailed to ensure that transfer will be successful.

Here is the link: https://www.who.int/docs/default-source/medicines/norms-and-standards/current-projects/qas20-865-gxp-for-research-and-development-facilities.pdf?sfvrsn=ae6d0bb8_2



Consultation ends on 6th January, 2021.



Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

First stem-cell therapy recommended for approval in EU

The European Medicines Agency (EMA) has recommended Holoclar, the first advanced therapy medicinal product (ATMP) containing stem cells, for approval in the European Union (EU). Holoclar is a treatment for moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns to the eye(s) in adults. It is the first medicine recommended for LSCD, a rare eye condition that can result in blindness.

For further details see EMA

Posted by Tim Sandle

SeaBioTech project

Spotlight on a new area of microbiology and antimicrobials: the SeaBioTech project.

The SeaBioTech project, started in 2012, is intended to close some of these knowledge gaps by looking in the seas and oceans around the globe for life forms with novel properties. The aim is to find raw material for the world's biotechnology industry, with a particular emphasis on antibiotics and other medical compounds.

The plan is for the project to sample organisms from a wide range of marine environments, ranging from the cold Atlantic sea off Scotland to the volcanically-active region near the Mediterranean island of Santorini.

Posted by Tim Sandle