The GMP requirements for ATMPs are very special
Advanced therapy medicinal products, (ATMPs) need special directives due to the huge heterogeneity of the products and the extreme variable development and manufacturing environments.
ATMPs are produced in small batches for personalized therapies only and even the manufacturing process is mostly still in development.
For this reason european regulating agencies under the hat of the EMA discussed a special GMP for ATMP guideline, which accommodates the features of manufacturing ATMPs.
The „Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products” was adopted by the European Commission at 22th of november 2017.
Valicare GmbH is well versed with the actual directives and offers accompanying consulting at the highest professional stage.
We transfer your specific lab protocol into GMP-compliant manufacturing processes and work out the specifications for your ATMP.
Additionally we prepare or support you with the preparation of the manufacturing documentation and the master documents, offer ATMP trainings and audit & inspection service.
Innovations of the new EU ATMP guideline
The production of medicinal products is a highly regulated process in accordance to the EU GMP guideline. While primary ATMP developers mainly do not have applied the crucial pharmaceutical quality system, the responsible european authorities adapted the „Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products” published at 22 th of november 2017, to the specific characteristics of ATMPs.
- Implemented flexibility which is necessary for the ATMP manufacturing process to guarantee quality, safety and efficacy of the product using a risk based approach
- Approval of continuous improvement of the manufacturing processes and production routines up to clinical trial Phase I/II
- Reduced administrative burden of the centralized marketing authorization with special exemptions of national authorities
- Safeguarding of market supply by permitting an automated production of ATMPs probably with particular clean room classification
Call us if you have any questions to the EU ATMP guideline.
Special characteristics of ATMP production
Between 2009 and 2016 about 500 clinical trials were registered using ATMPs. Mainly academic research institutes occasionally in hospital environments are the driving force. The increasing number of the promising ATMP development projects will hopefully create new therapies for actually irremediable or hardly treatable serious diseases.
ATMPs won’t be produced in big batches like conventional drugs. The small batches of customized products require very special and individualized manufacturing processes.
Overview about some special characteristics of ATMP production:
- Production is performed for individual therapy options and for small collectives in maximum
- Aseptic conditions are usually essential for ATMP production
- Small batch sizes (limited availability of the starting material)
- Inherent variability of the starting material (result in high demands on incoming inspection)
- Higher flexibility of manufacturing processes (due to variability of the raw and starting material)
- Very short shelf life of the product (require controls of on-going stability and quality)
Call us if you have any questions regarding the ATMP production.