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Methodenentwicklung

Method Development and Validation

The development and validation of a new method often seems to be hard and complex. Prior to the start, a lot of facts have to be considered. Beneath the availability of qualified personal the performance of the new method has to meet internal and general quality guidelines and should be suitable for everyday use.
Especially with biotherapeutics, you are forced to follow new analytical paths, as new synthetic pathways are explored continuously.

Save time, money and own resources, which might be used more efficiently elsewhere. Take advantage of the know-how and the capacity of the GBA Laboratory Group

In the field of human and veterinary drugs, biologic therapies and herbal medicines we offer:

Development and validation of new analytical methods for
  • APIs and raw materials used for pharmaceutics and biotherapeutics
  • chemically defined substances
  • Medical devices
Development and validation of impurity testing
  • Degradation products in finished formulations
  • By-products resulting from synthesis of active substances made for pharmaceutics and biotherapeutics
  • Trace components and detergents (Tween, Pluronic, Triton, ect.)
Development and validation of testing methods:
  • Genotoxic substances
  • Extractables and Leachables in primary packaging materials such as plastic containers for liquid dosage forms or plastic-coated tubes for ointments
Characterization of new medical plants and plant
  • Creation of mass balances, identification of lead compounds and determination of toxic by-products
Isolation, purification and characterization of impurities, degradation and other by-products

 

 

GBA PHARMA GMBH