Technology Transfer

Transfer of biologics manufacturing processes is a challenge with complexity and high risk. A solid and experienced CDMO partner with efficient procedures and proven workflow is crucial to ensure a smooth and successful technology transfer.

Wacker Biotech has experience in transfer of processes at different stages of the product lifecycle. Depending on the stage of your product and your current needs, we perform transfer and further development of early stage processes or transfer of commercial products to one of our 5 GMP facilities.

We transfer processes at any development or lifecycle stage of your clinical or commercial product. We are able to:

Transfer and further develop early stage products
Mirror production of commercial products to extend your manufacturing capacity
Establish a backup strategy for production to ensure an adequate market supply
Scale up to increase manufacturing batch sizes with enhanced efficiency
Scale down depending on your needs

A dedicated and experienced team with members from all involved areas is crucial. The core team including MSAT, process development, production, quality control and quality assurance coordinates and executes together with a dedicated project manager all transfer activities.

The ultimate goal is to achieve state-of-the-art processes with regulatory compliance, minimized risk, and short timelines, while keeping within cost projections.

Selected case studies

Transfer of an approved product

Customer: Chiesi
Product: Retavase® for treatment of acute myocardial infarction
Scope: Wacker Biotech has successfully transferred and implemented the entire commercial manufacturing process for reteplase from Roche to its GMP plant in Halle/Saale (Germany).

It also covered the validation of the analytical methods for process control and release testing of the drug substance. In close cooperation with customer Chiesi, Wacker Biotech established the supply of this high-quality drug substance for Chiesi's relaunch of Retavase® in the US market. It obtained approval from the European Medicines Agency (EMA) in 2012 and from FDA in 2018.

"WACKER is a proven leader in microbial technology. The collaborative effort and partnership have been outstanding.”

Alan Roberts, Senior Vice President of Scientific Affairs at Chiesi

Transfer of clinical Phase III vaccine

Customer: MinervaX ApS
Product: Prophylactic Vaccine Targeting Group B Streptococcus
Scope: MinervaX seeked to scale up supply of its novel GBS vaccine, ahead of phase III studies.

Wacker Biotech performed the technology transfer, process validation and process characterization of the manufacturing process for the active ingredients. Subsequently, Wacker Biotech will perform all key functions critical to ensure stable commercial supply at its site in Amsterdam, The Netherlands.

Wacker Biotech is a robust manufacturing partner with a strong track record in late clinical and commercial supply and we look forward to collaborating with the team ahead of commencing Phase III studies.

Per Fischer, CEO of MinervaX

Transfer of clinical stage product

Customer: Ascendis Pharma
Product: TransConTM CNP, a transiently conjugated peptide for treatment of achondroplasia, also known as dwarfism
Scope: The process for making the candidate based on Ascendis Pharma’s proprietary TransConTM technology was transferred successfully to Wacker Biotech GmbH in Jena at the start of this partnership.

TransCon™ CNP is manufactured there in compliance with pharmaceutical GMP requirements to ensure the high quality necessary for the approval of clinical trials or for market approval by the FDA or EMA. Wacker Biotech made the material both for the successful phase 1 trial and for the phase 2 trial that has been applied for.

Transfer, optimization and scale up

Customer: Fresenius Medical Care Adsorber Tec (Fresenius group)
Product: scFv-class antibody used in apheresis products for selective dialysis
Scope: Fresenius needed material in GMP quality. Low costs for antibody fragment were the key for this project.

WACKER improved the manufacturing process using its proprietary FOLDTEC® technology leading to reduction of the buffer volumes, increased yields and boosted purity. Transfer and scale up to 1,500 L facility led to successful GMP manufacturing.