Research Grade Production

Research Grade Production

Whatever your needs for non-GMP products, Bachem can prepare compounds according to your specifications in any scale – from milligram to kilogram and ton quantities. We are experts in producing complex peptides with a wide range of modifications using our well developed and proficient peptide synthesis techniques in combination with high capacity and state-of-the-art automated production equipment.

 

State of the art automated equipment

  • Solid Phase Peptide Synthesis (SPPS) using fully automated single / multi-channel peptide synthesizers including microwave technology
  • Downstream processing using High Performance Liquid Chromatography (HPLC)
  • In process analysis using HPLC, MALDI-mass spectrometry and Liquid chromatography–mass spectrometry (LCMS)

 

Quality Focus for Research Grade products

Following increasing quality requirements from our customers for non-GMP materials, at Bachem we have developed Quality Management Systems that are tailored to a range of applications, and provide a higher quality in terms of change control and documentation for compliance to regulatory standards.

Research Grade Plus

Over the last 50 years, Bachem has been the leading partner for peptides. We support our customers at every stage of product development, from early stage R&D all the way through to commercialization.

Bachem’s Center of Excellence in the production of Research Chemicals in St. Helens, UK holds ISO13485 certification for the manufacture of peptides used as raw materials in medical devices. The site uses state-of-the-art equipment and offers a comprehensive range of services including:

 

  • Medical Device File
  • Critical change control
  • Dedicated equipment
  • Customized vialing and generation of peptide mixes

Bachem Quality Grade

Bachem has also established the Bachem Quality Grade (BQG), because it guarantees that we meet our partner’s needs to comply with the current regulatory standards for cosmetic ingredients, or amino acid derivatives and building blocks. Bachem Quality Grade assures the batch-to-batch consistency of our products for your formulation.

The experience as supplier of peptides as active pharmaceutical ingredients (API) for the human and veterinary pharmaceutical market, makes us the perfect partner for high-quality raw materials with comprehensive change and deviation management.

What are the benefits of the Bachem Quality Grade?

  • Qualified supply of raw and starting materials
  • Dedicated compliance team responsible for quality management and release
  • Specifications with defined life cycle
  • Validated analytical methods
  • Change control for manufacturing processes, analytical methods and specifications
  • Deviation management
  • Manufacturing according to established processes and using qualified analytical equipment
  • TSE (Transmissible Spongiform Encephalopathy) / BSE (Bovine Serum Albumin) certificate
  • Outstanding purity

 

Our Service

In order to provide the best service for your needs, the Bachem Quality Grade captures the requirements of your demand in a quality and supply agreement. The following requirements can be provided to the needs of our partners:

  • Documentation can be delivered to your needs
  • Materials used for manufacturing and their traceability
  • Cleaning of production equipment according to defined procedures
  • Selected other production parameters
  • Packaging and storage

    Further topics of interest

    Catalog
    Peptides

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    Cosmetic
    Peptides

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    Custom
    Synthesis

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    Amino Acid
    Derivatives

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    Diagnostics
     

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