Webinar: Large-Scale Peptide Manufacturing

Edition 6 / November 2019
Peptides, Lipids & Carbohydrates Platform > Webinar: Scale-up Considerations for Large-Scale Peptide Manufacturing

Edition 6 / November 2019

Dr. Matthieu Giraud, Director, Global Peptides, Lipids & Carbohydrates Platform,
CordenPharma International, headshot

Author
Dr. Matthieu Giraud

Director, Global Peptides, Lipids & Carbohydrates Platform,
CordenPharma International


Webinar: Scale-up Considerations for Large-Scale Peptide Manufacturing

CordenPharma Colorado (US): 50’000L tank in green chemistry approach (solvent recovery) and large scale manufacturing concept

50’000 L tank farm to support our Green Chemistry approach (solvent recovery) and large-scale manufacturing concept in CordenPharma Colorado (US).

Register Here for our Upcoming Webinar
Scale-up Considerations for Large-Scale Peptide Manufacturing
by Dr. Robert Topping, Distinguished Scientist, CordenPharma Colorado
Wednesday, November 20 at 8 MST / 10 EST / 16:00 CET

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.

Figure 1: Top Sales April 2018 – March 2019 (Peptide Volumes [kg])

Graph Pictured: April 2018 - March 2019 Sales of Peptide by Volume [KG] for large scale peptide synthesis.

*12 months rolling as of 31st of March 2019, Source: Thomson Reuters, September 2019

Webinar: Scale-up Considerations for Large-Scale Peptide Manufacturing > Factors & Parameters to Address for Implementing Large-Scale Peptide Processes

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.

As a participant, you will:

  • >> Learn how large is large-scale peptide manufacturing.
  • >> What are the factors that change on large-scale manufacturing which could impact product quality & process operations?
  • >> What are the areas of risk encountered when scaling up?
  • >> Review safety, health & environmental considerations.

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