Fill&Finish: Technology transfer to GMP

A strong network of expertise: Formulation. Lyophilization. Process. Primary Packaging. Technology Transfer. Manufacturing. Fill&Finish.

As state-of-the-art development experts we are teamed up with state-of-the-art contract manufacturing experts to provide high-quality parenterals from pre-clinical to clinical and large commercial scale.

Competence, excellence, know-how, trust and a good network is key to every service provider in the pharmaceutical industry. Seldomly pharmaceutical development is executed by one single one-stop shopping partner. Often several CROs, CMOs and other partners are involved in streamlined pharmaceutical development, implying a high need on coordinating timelines, equipment, technologies and synergies. By building a competence network, we have understood early on the vast importance of seamless technology transfers from one partner to the other, thus mutually combining the features, advantages and benefits of each of the experts in the development chain. This way, research and development comes from us as development experts, and manufacturing and batch supplies come from our partnered manufacturing experts.

Further, members of our team have worked in all sectors of the Drug Discovery and Development pipeline, from API development to drug product contract manufacturing. We as a CRO for formulation and process development position our company in between drug substance development and drug product manufacturing – we transform drug substance (DS) into a stable drug product (DP). As we know what it needs to have a stable DS, we do aid in the DSP process as well to help design a stable DS formulation – harm (e.g. aggregates) that is done to the DS can never be made up in the DP (!) but stays with the molecule through its lifetime. As we know what it needs to manufacture a stable DP, we do aid in aligning the DP development to the challenges of contract manufacturing (e.g. slim formulation, slim process, modern but robust lyo cycle, appropriate primary packaging, process mock-up, etc.). Our processes can easily and smooth be transferred into contract manufacturing because we develop a quality product with foresight.

Our services to facilitate technology transfer: