Peptides for diagnostics and medical devices

Peptides for in-vitro diagnostics & medical devices

Peptides play a vital role in advancing medical devices and in‑vitro diagnostics, offering precision, reliability, and performance. Bachem is your partner for high‑quality peptide solutions tailored to your application needs.

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Your trusted partner

Production of peptides as critical raw materials for medical devices, with enhanced quality controls and traceability tailored to diagnostics.

Support across stages – from defining specifications to establishing robust, reproducible manufacturing processes for future commercial supply.

Medical device files (MDF), master production records, specification sheets and quality agreements; readiness for audits and regulatory inspections.

Controlled, documented management of changes to processes, materials, or equipment to protect assay performance and compliance.

Manual and automated dispensing with custom vial formats, volumes and mixture preparation to match kit assembly needs.

State-of-the-art analytical testing and stability studies to qualify peptides for IVD use and support shelf-life claims.

Capacity for parallel campaigns and scale ranges suitable for diagnostics (mg to multigram), enabling reliable kit component supply.

Long-term supply backed by experience in large-scale production and global, inspected facilities.

We developed a great partnership with Bachem AG since 2017. Real-time professional communication with Bachem specialists provided us with critical support for our products and allowed us to develop novel diagnostics solutions. High level of service and customer centricity are just a few of the great qualities we experienced with Bachem team. R-Biopharm is looking forward to strengthening this collaboration and, without any doubt, recommends Bachem as a reliable and trustable partner!

Yanis Tolstov

Chief Medical Officer, R-Biopharm AG

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Enquiry

The sequence is supplied by the customer. We identify specific customer needs within a thorough evaluation.

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Process development

We develop 2 to 3 independent research grade batches and define additional services. A simple, clear process aligned with customer goals is established.

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Specifications

To define specifications, a customer specification dossier is developed, as well as a Bachem technical specification sheet, a master production record and a quality agreement.

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Commercial supply

Customers can review the batch production record on-site. Critical change control is implemented. Peptides provided based upon purchase order of supply agreement according to specified quality.

Our Awards

ISO 13485 Certificate

Why choose Bachem

Accelerate IVD development

End-to-end support from R&D to commercialization shortens timelines and reduces risk.

Ensure certified quality

ISO 13485-certified manufacturing guarantees consistent, traceable peptides for in-vitro diagnostics with Research Grade Plus.

Meet regulatory demands with confidence

Robust documentation, change control, and audit readiness safeguard compliance throughout the product lifecycle.

Customized to your workflow

Tailored vialing, dispensing, and packaging solutions align with kit assembly and automation needs.

Leverage experience for complex peptides

Advanced capabilities in challenging sequences and large-scale production ensure a reliable supply.

Partner for long-term success

Dedicated technical and business teams provide proactive support and sustainable supply chain solutions.

The perfect fit for Peptide-based IV-diagnostics

Our Center of Excellence for Custom Synthesis in St. Helens, UK, is ISO 13485 certified to manufacture Peptides as critical raw materials for medical devices. Learn more about how we ensure that our Peptides for IVD applications meet regulatory requirements in our webinar.

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High-level service