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Experimental design (QbD)
Optimisation on a laboratory scale
Scale up parameters
Transfer to production
Verification in production plant
Including tendering for outsourcing partners, project management, all GMP documentation, qualifications and validations.
Our trade fair dates 2022
We shall propose an implementation to you!
Thank you very much! We will get back to you shortly.
We offer you the entire processing for your production. From finding the right CMO with price negotiation, scale up, technology transfer, all GMP documents, to process validation at the manufacturer.
Scale up is the first and most important step in production. Especially in the case of biopharmaceutical products, this is where the subsequent costs over the entire product life cycle are decided.
A continuously optimised process delivers products of consistent, good quality and "in time". This is where the manufacturing costs are decided.
We are familiar with aseptic manufacturing processes often used for biopharmaceutical products: We consider freeze-drying, sterile manufacturing and filling to be the most important techniques.
The more precisely the raw materials, APIs and the manufacturing process are characterised, the easier it is to prove the conformity of the products to specifications and regulations. We offer you method transfer incl. validations.