Edition 6 / November 2019
The growing number of therapeutic peptides in clinical trials and a significant increase of therapeutic indications for peptides are the key drivers for capacity expansion by leading CDMOs (Contract Development & Manufacturing Organizations) in the global peptide API market. Although the early peptides were hormones, therapeutic peptides are now being developed for almost every therapeutic category ranging from anti-inflammatory to cancer therapeutics.
Under CordenPharma’s Peptides Lipids & Carbohydrates Platform, we aim to support you, leading pharmaceutical & biotechnology customers, with Delivered in Full & On Time (DIFOT) products & services. Our ultimate stakeholders and beneficiaries are naturally the patients, in critical need of the sophisticated medications we produce.
At CordenPharma Colorado, we have multiple years of experience producing Enfuvirtide (FUZEON®) at ton scale, thanks to our large 10’000 L SPPS vessel and our 80 & 100 cm columns. As a reference, Liraglutide and Glatiramer will reach the ton scale in 2019 (see figure 1), while other diabetes peptides are showing the same trend to extremely high volumes.
The chemical and operational challenges and risks of peptide synthesis are magnified when considering the transition from lab-scale preparation to large-scale plant manufacturing. Scaling a process can compound the economic and quality risks of not having complete understanding and control of the critical elements that influence the quality, operability and safety of a successful peptide production program.
Many factors have evolved to increase the need for large-scale peptide API manufacturing. The very growth, diversity and evolution of peptide therapeutics that creates the need for large-scale peptide manufacturing also drive the complexity & variability of the synthetic approaches, scale-up strategies and controls that need to be applied. The variability encountered with each new peptide product presents a myriad of challenges during scale-up of not only the synthesis, but can also impact the stability, purity & processability during down-stream processing.
The synthesis, purification and isolation of a peptide product all have interdependent impacts on the quality of the product. In addition to the science of scale-up manufacturing, the support roles and strategies around equipment, campaign management, raw material procurement, waste management and safety also have changing impacts when applied to large-scale.
Register now for this webinar, which will identify aspects of scale-up peptide manufacturing that the
CordenPharma Colorado manufacturing site has focused on for large-scale development and implementation of commercial peptide APIs. These aspects, along with their associated benefits & challenges, will be presented as topics that an organization needs to consider, identify and manage in order to prepare & develop successful manufacturing strategies and process controls.
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