Trending topics at PolyPeptide
Expert views
We are proud of our colleagues who regularly present at industry conferences to share their latest expert insights and experience in peptide manufacturing. Four of them recently presented at TIDES USA 2024, and we are happy to share the video recordings. Their topics document our continuous innovation efforts to meet evolving quality requirements and to improve sustainability for growing manufacturing volumes.
- Eran Benjamin, Global Director QC/AD: “Tailoring Control Strategies to Meet Specific Peptide Drug Substance Complexity, Customer Needs and Regulatory Requirements” Process analytical control strategies are built from the incoming starting material supply, process and purge capabilities, analytical control strategies, risk assessment tools and state of the art analytical methods. Different customers and regulatory agencies are requiring different levels of risk management and control. This presentation will showcase several peptide drug substance examples of managing customer and regulatory expectations, while assuring supply chain capabilities.
- Jean-Marc Proudel, Head of Regulatory Affairs at PolyPeptide SA: “High-end Analytical Tools to Meet the Latest Regulatory Requirements for Generic Peptides – A Case Study” While regulatory requirements for generic peptides applications are becoming more and more demanding, the existing analytical tools and techniques are pushed to their limits to deliver the appropriate performance (resolution, sensitivity, precision). This presentation will go through a recent case study for a synthetic generic peptide of recombinant origin, where several high-end analytical techniques have been used to overcome the challenges of the most recent FDA guideline in this area.
- John Lee, Associate Director Innovation: “Novel Branching Method for Solid Phase Peptide Synthesis” At present, Polystyrene resin based solid phase peptide synthesis (SPPS) is the “go to” method for both research and industrial scale peptide syntheses. At industrial scale however, the current SPPS introduces major drawbacks; large reactor requirements and enormous amount of chemical wastes generated making synthetic peptides one of the most expensive molecules to produce. We report highly effective “multiple dendrimeric” constructs for the use in SPPS. With the novel branching arrangements with “spacers”, we demonstrated product yield up to 8-fold increased compared to traditional method of SPPS. Peptide size up to 50 amino acid long in length with comparible purity to conventional peptide synthesis has been demonstrated. Furthermore, we show that this approach reduces reactor size which gives signficant application advantages to industry for reducing wastes and facility size.
- Brad Grossman, Head of Manufacturing, PolyPeptide Inc.: “Study for the Novel Energy Efficient Approach for Reclaiming Acetonitrile in Peptide Manufacturing” In the past, acetonitrile has primarily been recovered by multistage distillations. While these can be effective, they also come with some processing limitations and challenges. An alternative pilot scale system has developed which demonstrates a new approach to recovering this critical solvent for peptide manufacturing and greening processes.
Building on our deep knowledge and innovative approaches, we strive to be your preferred partner for development and manufacturing.