GMP Quality & Regulatory Compliance

We're committed to meeting the increasing demands of therapeutic cell manufacturing. Our animal-free facility in St. Paul, Minnesota supports large-scale production of GMP-grade, E. coli-derived recombinant proteins.

• Entire facility dedicated to manufacturing GMP proteins
• Completely animal-free – no animal components are allowed in the facility
• 61,000 sq. ft. capacity to meet your current and future supply requirements
• Expandability – Available space to build additional capacity
• ISO 5/7/8 cleanrooms for the entire production process

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. Please see our certifications for more information.

• ISO 9001:2015 and ISO 13485:2016 certified facilities including a completely animal-free facility dedicated to manufacturing GMP proteins
• 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

We pay strict attention to detail at all levels of the protein manufacturing process. Our quality management systems for GMP proteins include detailed Standard Operating Procedures (SOPs) and quality-controlled documentation of the manufacturing equipment and procedures. You can rely on our GMP proteins for building a consistent and robust cell therapy manufacturing program.

• Biological potency specification
• Defined purity specifications
• Stability testing program
• Defined endotoxin specifications
• Host cell protein content testing
• Sterility testing according to USP
• Additional testing available depending on your needs

Full documentation and traceability from start to finish. We work with preferred vendors for raw materials to mitigate risk and adhere to a strict definition of animal-free conditions. Certificates of Origin (COOs) are available upon request.

• Individual specification sheets with all testing results, reviewed by both our Quality Control (QC) and Quality Assurance (QA) departments
• Lot-specific Certificates of Analysis (CoA), see below
• 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, traceability, 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
• Stability monitoring over the shelf life of each product
• Product change notifications
• Regular audits of our facilities

Each manufactured lot of GMP protein has a Certificate of Analysis (CoA) that documents the relevant quality systems and product specifications. Prior to CoA release, we conduct a full QA review of all batch and bottling records. 

Here is what you can expect to find on our CoAs:

• Actual vial fill (protein mass) for accurate reconstitution
• Source information
• N-terminal sequencing of the first 10 amino acids
• Purity specification
• Bioactivity assay including benchmarking against a master lot
• Sterility testing to USP
• Endotoxin levels
• Host cell protein specification
• Host cell DNA specification
• Stability statement
• Certifications and regulatory guidelines followed

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

Wherever possible, our GMP reagents are manufactured using entirely animal-free processes and equipment to minimize variability and reduce the risks associated with animal-derived components. This commitment supports safer, more consistent processes and simplifies regulatory considerations. 

Produced in a dedicated animal-free facility using E. coli expressions systems, our animal-free proteins will never come in contact with animal-containing materials. Our animal-free proteins share the same biological activities as those produced for our standard research grade, easing the process of transition between protein formats.

• Animal-free Certificates of Origin from raw material suppliers.
• All raw materials are traceable through batch records
• Fermentation and purification processes follow approved SOPs
• Validated equipment cleaning procedures
• Dedicated animal-free fermenters
• Bacteria are grown in animal-free media
• Dedicated product-specific, animal-free columns
• Column cleaning validated for animal-free manufacturing
• Proteins filtered using certified animal-free filters
• Animal-free labware
• Animal-free containers and dedicated cold storage room
• Classified vialing clean room and dedicated animal-free lyophilizer
• Animal-free vials, stoppers, and crimp caps