Biotechnology Scale Up & Scale Down
What our customers say:
We were able to go directly from the lab to clinical production! Thanks to the excellent scalability and the models developed, we no longer see a problem for validation and transfer to the CDMO!
What are the challenges of your project?
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Biotechnology Scale Up
The most important step in technology transfer!
Scale up & technology transfer
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.
Optimisation of production
A continuously optimised process delivers products of consistent, good quality and "in time". This is where the manufacturing costs are decided
Aseptic processes (Fill & Finish)
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.
Analytical method transfer, validation
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.