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The crux of penicillin application in cell culture for ATMP manufacturing, 13th of March 2019

The group of Advanced Therapy Medicinal Products (ATMPs) enclose gene therapy medicinal products, somatic cell therapy medicinal products and biotechnological treated tissue products. Manufacturing of these medicinal products to the compliance of legal requirements of Good Manufacturing Practice (GMP) guidelines is a major challenge. Patient individual manufacturing, with marginal batch sizes and not completely standardized or rather not standardizable processes originated from university research, need a higher flexibly in the interpretation of GMP compared to the manufacturing of classic medicinal products. The new GMP guideline for ATMPs, valid since May 2018, incorporates the complexity of the manufacturing process. However, some questions concerning ATMP manufacturing, for example application of antibiotics, remain open.

Patient individual manufacturing requires autologous cells or tissues, whereas extraction in clinical institutes represents a concrete risk for contamination. To reduce bacterial contamination, antibiotic cocktails of penicillin/streptomycin are often added at an early stage of ex vivo culturing of cells or tissues.

This is in contradiction to the GMP guidelines comprising strict demands on the application of highly active substances like penicillin during pharmaceutical manufacturing. The application of penicillin is prohibited through manufacturing process of medicinal products and, to exclude a possible cross-contamination with penicillin or other substances of the beta-lactamases, the final product has to be analyzed for the absence of rather those compounds. The real challenge here is the establishment of an adequate detection system with equivalent validation.

Cultivation without antibiotics is also an alternative strategy, but in some cases, application of penicillin in ATMP manufacturing process cannot be avoided. The impact of contamination of the starting material used for production of the valuable ATMP and the risk for it’s unusability, must be considered. Finally , the loss of the medical product for patient´s therapy justifies the application of antibiotics preventing contamination.

But which options exist for ATMP manufacturer and how can the guidelines concerning the application of antibiotics be handled?

This is where Valicare can advise you and offer risk-based solutions. If you have further questions on this or other ATMP-related topics, please do not hesitate to contact us. Call us (0049 (0)69 7909 350) or send your question by email (info@valicare.com). We will forward you or your question to our ATMP specialists Dr. Claudia Papewalis and Dr. Hans-Georg Eckert.

 

Further information


 
Dr Claudia Papewalis is giving a GMP for ATMP training

GMP for ATMPs

If you want to know more about the regulatory requirements requested for manufacturing ATMPs, contact our experts or take part at one of our internal GMP training courses.

A scientist is looking at t-cells visible at a computer screen

GMP-compliant manufacturing process

Valicare supports start-ups like polybiocept in transferring cell-culturing methods developed at the laboratory into a GMP-compliant manufacturing process. Check the press release and get an overview about our GMP for ATMP services.

cell culture, ATMPs

„Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products”

On 22th of November 2017 the European Commission adopted the "Guidelines on Good Manufacturing Practices (GMP) specific to Advanced Therapy Medicinal Products".