Company insight
End-to-end peptide manufacturing
PolyPeptide is a specialised contract development and manufacturing organisation (CDMO) for peptide- based active pharmaceutical ingredients (APIs) or intermediates in therapeutic products. By supporting its customers in pharma and biotech, it contributes to the health of millions of patients across the world.
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olyPeptide operates six cGMP-certified manufacturing sites strategically located across the US, Europe and India. This footprint provides its customers with more flexible options to support their supply chain and growth strategies. The facilities feature advanced technology platforms for both solid-phase peptide synthesis (SPPS) and liquid-phase synthesis, allowing PolyPeptide to meet a wide range of production needs – from small clinical batches to high-volume commercial supply. With close to 1,300 employees worldwide as of the end of June 2025, PolyPeptide brings together chemists, engineers, analysts and regulatory specialists who collaborate to solve complex manufacturing challenges. Recruitment is a continuous strategic focus, ensuring PolyPeptide maintains expertise and capacity to meet evolving market demands.
Expert support for phase I projects PolyPeptide delivers high-quality GMP production for toxicology studies and phase I clinical programmes, where timelines are often compressed, and quality expectations are non-negotiable. The CDMO focuses on efficiently meeting these accelerated schedules without compromising on regulatory compliance, technical robustness or long-term scalability. PolyPeptide’s approach for early clinical production includes: ■
rapid GMP manufacturing in line with ICH, FDA and EMA guidelines
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scalable process design to support smooth transition to later phases and commercial production
regulatory insight to help anticipate requirements and avoid delays during clinical advancement
supply chain planning that considers commercial requirements from the outset, reducing the risk of future disruptions
www.worldpharmaceuticals.net
PolyPeptide’s collaborative approach ensures that clients benefit from tailored solutions.
Clinical manufacturing PolyPeptide supports manufacturing through all clinical phases, moving seamlessly from small-scale batches for early-stage trials to large-scale production for pivotal studies and market launches. Its commercial infrastructure offers significant capacity, delivering consistent quality and cost-efficiency for global supply.
Regulatory expertise
The regulatory affairs team has deep experience with submissions to health authorities worldwide, including the FDA, EMA and PMDA. PolyPeptide provides complete documentation packages, manages updates throughout the product life cycle and guides clients through complex regulatory processes to ensure market readiness.
Addressing industry challenges The peptide industry faces a variety of technical and logistical hurdles. PolyPeptide addresses these with proven strengths: ■
Strategic raw material sourcing: The company maintains multiple qualified suppliers and long-standing
partnerships for critical raw materials, securing supply resilience and regulatory compliance.
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Complex and long peptides: Its technical teams excel at producing challenging molecules, including long sequences, cyclic structures and post- translationally modified peptides. It uses advanced synthetic strategies – such as hybrid SPPS/liquid-phase approaches and orthogonal protection schemes – to achieve the highest quality outcomes.
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Scalable manufacturing processes: PolyPeptide designs processes with scalability in mind, reducing the need for redevelopment as products progress from early trials to commercial supply.
Commitment to quality PolyPeptide invests continuously in process intensification, manufacturing automation and analytical technologies. Its quality systems comply with ICH standards and the requirements of leading regulatory agencies, helping to ensure that every product meets or exceeds specification. ●
www.polypeptide.com 73
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