Start your journey in the Karolinska Pre-GMP facility

Whether you’re a researcher, clinician, or industry professional, Pre-GMP core facility in Ana Futura provide the necessary tools and expertise to advance your ATMP development journey.

The Pre-GMP core facility at ANA Futura is located in Campus Flemingsberg and offers a seamless transition from research to production, focusing on the safe translation of Advanced Therapy Medicinal Products (ATMPs) from the laboratory to the clinic.

Pre-GMP encompasses process development conducted from the research laboratory to production in a Good Manufacturing Practice (GMP) facility. At the Pre-GMP facility, you can:

  • Learn the basics of GMP production
  • Transform research protocols into standardized operational procedures (SOPs) under GMP-like conditions
  • Develop SOPs and procedures that can be transferred to a GMP facility
  • Do validation runs that do not require GMP standards
  • This is also a resource for academia, health care and industry

 

 

” A pre-GMP facility facilitates the transition from making a discovery in the research lab to developing it for drug production, i.e., according to Good Manufacturing Practice (GMP). In the pre-GMP facility, techniques can be tested and protocols developed, which are then transferred to a GMP unit. This makes development easier and cheaper”, – Matti Sällberg, Professor at the Department of Laboratory Medicine at Karolinska Institutet.

Read the article here >

 
Continue your journey to GMP Production >