PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange.
Global Network and Resources
We operate six cGMP-compliant manufacturing sites strategically located across the United States, Europe, and India. This footprint gives our partners flexibility, security of supply, and access to region-specific expertise. Our facilities feature advanced technology platforms for both solid-phase peptide synthesis (SPPS) and liquid-phase synthesis, allowing us to meet a wide range of production needs — from small clinical batches to high-volume commercial supply.
Expert Support for Tox and Phase I Projects
PolyPeptide delivers high-quality GMP production for toxicology studies and Phase I clinical programs, where timelines are often compressed, and quality expectations are non-negotiable. We specialize in meeting these accelerated schedules without compromising on regulatory compliance, technical robustness, or long-term scalability.
Our approach for early clinical production includes:
- Rapid GMP manufacturing aligned with ICH, FDA, and EMA guidelines.
- 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.
Clinical and Commercial Manufacturing
We support 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. Our commercial infrastructure offers significant capacity, delivering consistent quality and cost efficiency for global supply.
Regulatory Expertise
Our regulatory affairs team has deep experience with submissions to health authorities worldwide, including the FDA, EMA, and PMDA. We provide complete documentation packages, manage updates throughout the product lifecycle, and guide 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
We maintain multiple qualified suppliers and long-standing partnerships for critical raw materials, securing supply resilience and regulatory compliance. - Complex and Long Peptides
Our technical teams excel at producing challenging molecules, including long sequences, cyclic structures, and post-translationally modified peptides. We use advanced synthetic strategies — such as hybrid SPPS/liquid-phase approaches and orthogonal protection schemes — to achieve the highest quality outcomes. - Scalable Manufacturing Processes
We design processes with scalability in mind, reducing the need for redevelopment as products progress from early trials to commercial supply.
Commitment to Quality and Innovation
We invest continuously in process intensification, manufacturing automation, and analytical technologies. Our quality systems comply with ICH standards and the requirements of leading regulatory agencies, ensuring that every product meets or exceeds specification.
Partnering for Success
PolyPeptide’s collaborative approach ensures that clients benefit from tailored solutions, open communication, and the full capabilities of our global network. Whether delivering Phase I materials under tight timelines or supplying large-scale commercial volumes worldwide, we bring the infrastructure, expertise, and insight required to deliver success.
By combining our global footprint, deep technical knowledge, commitment to talent acquisition, and proven track record in solving manufacturing challenges, PolyPeptide is positioned as the partner of choice for peptide and related therapeutics from early clinical production to commercial reality.
