About Silke Bolte

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So far Silke Bolte has created 2 blog entries.

May 2018

Top 5 tips & Interview in “In focus” of RegMedNet

Are you well prepared for large-scale commercial manufacturing?

Interview – Raw materials considerations for GMP manufacturing

In this interview, Bernd Leistler, Vice President Development & Production, CellGenix GmbH, discusses how raw or ancillary materials can affect cell therapy development and manufacturing. Read the interview here.

Infographic – Top 5 tips to prepare you for large-scale commercial manufacturing

Discover how you can ensure your GMP grade raw material supply chain is prepared for commercial manufacturing. Check out the Top 5 Tips infographic here.

 

Read the entire In focus on cell therapy development from RegMedNet

March 2018

Technote – Consistency Studies

New Technote – Batch-to-Batch Consistency of CellGenix® GMP Cytokines

We confirmed that the batch-to-batch consistency of our CellGenix® GMP cytokines is very high

Inconsistent product performance of raw materials causes deviations in the cell therapy manufacturing process. It is unlikely that you will be able to use the same raw materials batch during all stages from early clinical studies to commercial manufacturing. It is therefore crucial to choose GMP raw materials with a high and reliable batch-to-batch consistency. This will allow you to plan your manufacturing process as accurately as possible and save time and cost of goods on incoming controls and revalidations.

To make sure your manufacturing process is not influenced by using different batches of GMP cytokines, we have performed batch-to-batch consistency studies for our key CellGenix® GMP cytokines. These studies demonstrate that our batch-to-batch consistency is very high over the full range of production.

Please download the Technote to have a detailed overview of our batch-to-batch consistency studies.

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