GMP Quality Policy and Regulatory Support

GMP Protein Quality Policy

R&D Systems provides industry-leading quality and regulatory support for GMP ancillary and raw materials, including recombinant cytokines and growth factors, used in ex vivo cell therapy manufacturing. Using our experienced quality and manufacturing teams, our goal is to provide cell therapy manufacturers with a consistent, safe, and continuous supply of GMP-grade raw materials. View our portfolio of GMP proteins.

Consistency Safety Supply Chain Continuity Regulatory Policies Animal-Free Process

 

Summary of Quality Policies

  • GMP proteins are manufactured in our ISO 9001:2015, ISO 13485:2016-certified facility in Minneapolis, MN
  • Follow USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
  • Follow Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
  • Dedicated Animal-free manufacturing space
  • Lot-specific Certificates of Analysis
  • Raw material traceability
  • 35 years of protein manufacturing experience
  • Regular audits of our facilities
 

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Consistency

Patient safety is of utmost importance. R&D Systems® GMP proteins undergo a battery of physical tests as well as assessments for adventitious agents and contaminants. We use preferred vendors for raw materials to mitigate risk and adhere to a strict definition of animal-free. Certificates of Origin (COOs) are available upon request.

Consistency Supported by Documentation and Traceability:

  • Individual specification sheets with all testing results are reviewed by both our Quality Control (QC) and Quality Assurance (QA) departments
  • A full QA review of all batch and bottling records before any material is shipped
  • Documented processes and QA control of documentation and process changes
  • Personnel training programs
  • Raw material testing, tracing, and vendor qualification/monitoring
  • Fully validated equipment, processes, and test methods
  • Equipment calibration schedules using a computerized calibration program
  • Facility maintenance and safety programs
  • Material review board for variances
  • Monitoring of stability over product shelf life
  • Product change notifications
 

Safety

To ensure a consistent product, extraordinary attention to detail is needed at all levels of the protein manufacturing process. The quality management systems for GMP proteins at R&D Systems include detailed Standard Operating Procedures (SOPs) and quality-controlled documentation of the manufacturing equipment and procedures. These industry-leading systems, including the bulleted items below, are why our GMP proteins can be relied on for cell therapy manufacturing.

Quality Control Testing Includes:

  • Biological potency specification
  • Defined Purity Specifications
  • Stability testing program
  • Defined endotoxin specifications
  • Host cell content testing
  • Sterility testing according to USP
  • Viral testing of eukaryotic cell banks and viral reduction studies - Contact us for details
  • More testing available depending on your needs
 

Supply Chain Continuity

We understand the critical nature of having a stable supply of GMP-grade proteins for use as raw materials in ex vivo cell manufacturing. This becomes progressively more important during the transition from early- to late-stage clinical trials.

We have the expertise and ability to scale up your GMP protein supply. Working with your forecasting, we will provide supply and quality agreements to ensure the consistent supply of the GMP proteins you require.

Our Stable Supply Process Includes:

  • Supply and quality agreements
  • Risk mitigation management
  • Secondary cell banking facility
  • Quality-controlled change and notification process
 

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Regulatory Certifications and Guidelines

As a pioneer in cell and gene therapy solutions, our quality management system stays up-to-date on guidance within this exciting and rapidly evolving field, to provide the safest and most compliant GMP proteins and cytokines for ex vivo manufacturing. Our GMP growth factors and cytokines are manufactured using the most current regulatory certifications and guidelines, including:

  • ISO 9001:2015, ISO 13485:2016-certified manufacturing facility in Minneapolis, MN
  • USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
  • USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
  • Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
 

Animal-free Manufacturing

To support developing research and bioproduction demands, we have quality-controlled manufacturing space dedicated to the production and purification of recombinant proteins under completely animal-free conditions.

For more detailed information, please visit our Animal-free Recombinant Proteins page

Animal-free

Production and purification procedures use equipment and media that are certified animal-free. Our dedicated controlled-access animal-free laboratories ensure that at no point in production are these products exposed to potential contamination by animal components or byproducts. Some GMP proteins are manufactured under an animal-free process.

Read more about our Animal-free Process and Quality Control

ACFP (Animal Component-free Process)

ACFP recombinant proteins are expressed in an animal-free certified Sf9 insect cell line using dedicated animal-free raw materials and labware. Production and purification procedures use equipment and media that are confirmed animal-free but performed outside our dedicated animal-free laboratories. Some GMP proteins are manufactured under an animal component-free process.

Read more about out Animal Component-free Process and Quality Control