By Bachem AG
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Bachem video focuses on manufacturing complex peptide API generics
Bubendorf, Switzerland: – Peptide technology specialist Bachem has released a video interview with one of its specialists that explores the complexities of manufacturing complex peptide-based active pharmaceutical ingredients (APIs), including those used in generics.
The video ‘Generic Active Pharmaceutical Ingredients – Liraglutide and other GLP-1 analogues’ is hosted on YouTube (see Resources) and features a ‘guided tour’ from Bachem Group Leader Sales, Generics Sergey Malashikhin on the technical and analytical capabilities and innovations, involved in the manufacture of complex synthetic peptides.
Leading edge technologies
He focuses on the synthetic Active Pharmaceutical Ingredient (API) liraglutide and Bachem portfolio of GLP-1 analogues as remarkable examples of the process efficiencies and leading edge manufacturing and purification technologies required to deliver large volumes at a competitive price.
‘There is more to creating APIs for generics than simply following a recipe,’ says Mr. Malashikhin, explaining that a whole multidisciplinary approach is required, including development expertise and support services around the molecule that accompany customers from manufacturing to regulatory approval and delivery.
The full Bachem package for generic APIs includes production capabilities from mg to tonne scales, in-house manufacturing of source materials, an extensive and evolving catalog of molecules and DMF drug dossiers, comprehensive documentation, and regulatory know-how.
Move to SPPS
Sergey also identifies Bachem’s move beyond traditional recombinant methods to adopt SPPS solid-phase peptide synthesis, combined with quality by design approach and efficient purification methods, as key factors in ensuring efficient and high-quality production of GLP-1 analogs like liraglutide and semaglutide.
“Using this process, we obtain these APIs with high purity and minimized batch-to-batch variation, ensuring a strict control of every individual impurity and aggregation behaviour. Then, the similarity of the generic API with the original drug substance is proved with a combination of multiple sophisticated orthogonal analytical methods. It allows us to make detailed comparison with the reference listed drugs followed by immunogenicity and toxicological studies for individual impurities,” he explains.
Innovation as strategic pillar
Sergey Malashikhin recognizes the role of Bachem Innovation in ensuring technological leadership and international competitiveness.
“We are constantly assessing and developing 2nd generation processes for our generics, along with increasing process efficiency, implementing the latest manufacturing and purification technologies to deliver large-scale quantities at competitive prices, yet without jeopardizing product quality and continuing to stay in line with the strictest regulatory guidelines,” he notes.
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company, which has over 50 years of experience and expertise, provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services.
Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.
For further information, see www.bachem.com.
Click on Generic Active Pharmaceutical Ingredients – Liraglutide and other GLP-1 analogues to watch YouTube video.
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