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GMP Product in Vial graphic

At Bio-Techne, we are proud to take a supporting role in Cell and Gene Therapy manufacturing. We recognize the promise of cell and gene therapy as well as the increasing demand for GMP-grade raw materials and services. Although the challenges surrounding this industry are numerous, we can reduce your manufacturing risks by providing industry-leading quality, consistency, reliability, and capacity. You can advance seamlessly into regulatory agency submissions with our regulatory affairs team as a partner.

Our GMP products are intended for use as ancillary or raw materials in GMP manufacturing of investigational or marketed clinical products, such as cell therapy, gene therapy, tissue-engineered products, combination products, or other Advanced Therapy Medicinal Products (ATMP). They are not therapeutic products or excipients and are not suitable for direct administration to humans. For simplicity, we use the term GMP to cover both our products and our manufacturing processes.

In the GMP Facilities section below, you will find the quality standards and certifications for each of our GMP facilities as well as our quality control testing capabilities. We strive to ensure lot-to-lot consistency and minimize supply chain roadblocks that can cause expensive manufacturing process delays. We serve clients from around the world, and we guarantee the confidentiality of every contract.

Quality Compliance

Our Quality Team includes more than 120  employees in quality and regulatory roles worldwide. We ensure compliance with all relevant guidelines from governing authorities. 

Our team oversees:

  • Personnel training programs
  • Facility maintenance and safety programs
  • Validation of equipment and equipment calibration schedules
  • Raw materials inspection, testing, and tracing
  • Supplier qualification
  • Material review board oversight of variances

Our QA team also oversees documentation covering processes and process changes, product change notifications, test methods, individual SOPs and batch records, lot-specific certificates of analysis, and certificates of origin. We perform a full QA review of all batch and bottling records before any material is shipped.

Each of our facilities is regularly audited by clients.

We are experienced in both on-site and virtual audits.

Request a GMP Quality Consultation 

Transitioning Research to GMP

As you advance from discovery into process development and clinical manufacturing, we make the transition as efficient and seamless as possible. Our GMP materials are based on our research-grade products wherever possible. If GMP-grade materials are not available, our Custom Services team will work with you to convert RUO materials into products appropriate for manufacturing use. We have recently developed an intermediate tier of small molecules to meet the rapidly increasing needs of the cell therapy industry.

Our Ancillary Materials Grade Small Molecules molecules are certified animal-free and supported by enhanced QC testing, a more detailed QA review, and accompanying documentation. Incorporation of GMP or AM-grade raw materials early in your program will simplify your clinical transition. Our diligence with quality control ensures that you can move seamlessly into regulatory agency submissions without disrupting your process. 

Custom Services

We understand that cell manufacturing processes are optimized for individual outcomes. We will work with you to develop and deliver GMP raw materials and services that meet your specifications. We can provide customized vialing as well as construct design, formulation, and quality control analysis. With a dedicated project manager, our expert scientists, quality assurance team, and world-class technical support, we will deliver solutions exactly tailored to bring you success faster and more economically.

Benefits of Custom Services from Bio-Techne

  • Scientific expertise and dedicated project managers
  • Performance consistency
  • Timeliness of supply
  • Regulatory support
  • ISO-certified Quality Management System and FDA registered
  • Confidentiality

What You Can Expect

  • Consultation with our experts to define the need
  • Refining the project specifics, milestones, and deliverables
  • Regular project updates
Raw Materials at Scale graphic

We have recently collaborated with Phacilitate Exchange to bring you this eBook that discusses best practices for scaling up raw materials in cell and gene therapy manufacturing.

Read about Raw Materials at Scale 

What Animal-Free Manufacturing Means to Us

Animal-free protein manufacturing minimizes performance variables and risk caused by trace animal components or mammalian pathogens. Each of our animal-free proteins is produced from an E. coli expression system, not mammalian cell lines. There is no animal component used anywhere in the manufacturing process. When possible, our GMP proteins are made in an entirely animal-free process.

Animal-free Manufacturing Conditions

We maintain a completely animal-free environment; no animal-containing materials are permitted inside the facility or in contact with the laboratory equipment. The facilities are constructed to ensure there is no exposure of the product to contamination by animal-containing components, and there is clear segregation of all labware such as plasticware, tubing, gloves, pipette tips, and instruments. 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 Raw Materials, Instrumentation, and Equipment

  • 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 

Read Our Animal-Free Statement

Find Out Where We Make These Products

GMP Manufacturing Facility in Saint Paul, MN

We have recently invested even more in the future of cell and gene therapy, because we are committed to supporting the increasing demand for GMP-grade ancillary proteins. We anticipate that our new state-of-the-art animal-free GMP Manufacturing Facility will be fully validated for operation in Spring 2021.

Inquire About Our GMP Capabilities 

This video is a quick introduction to our new facility with approximately 61,000 square feet dedicated to supporting large-scale production of GMP-grade materials including E. coli-derived recombinant proteins. Multiple fermenters and purification suites allow us to manufacture the large quantities of GMP proteins required in cell and gene therapy manufacturing processes.

Bio-Techne Headquarters in Minneapolis, MN

Our headquarters facility, home to R&D Systems, hosts a comprehensive team of expert scientists and proudly manufactures R&D SystemsGMP recombinant proteins, GMP antibodies, GMP cell culture products, and custom GMP projects.

Certifications

Regulatory Guidelines Followed and Applicable Standards Followed 

  • Quality System Regulations for Medical Devices
  • Code of Federal Regulations (21 CFR 820)
  • USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
  • USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
  • Applicable sections of the World Health Organization Good Manufacturing Practices for Biological Products: TRS, No 822, 1992 Annex 1
  • Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
  • The In Vitro Diagnostic Directive 98/79/EC
  • The Canadian Medical Device Regulation

Standard Testing for GMP Proteins Includes

  • Mass spectrometry
  • HPLC
  • SDS-PAGE
  • N-terminal sequencing for first 10 amino acids
  • Mycoplasma
  • Endotoxin
  • Purity
  • Host cell protein and DNA
  • Bioburden/sterility in accordance with USP 71
  • Validated activity
  • Formal stability testing program over product shelf-life

Additional On-site Capabilities for Enhanced QC Testing

  • High resolution mass spectrometry: Intact mass, post-translational modifications, protein identification
  • Gel permeation chromatography/size exclusion chromatography (GPC/SEC): Aggregation assessment
  • Reverse phase HPLC: Purity assessment can reveal truncations, mixed disulfide patterns, and more
  • Light scattering analysis (SLS, DLS): Aggregation, oligomer analysis, and molecular weight determination when used in tandem with analytical sizing aggregation, oligomer analysis, and molecular weight determination
  • Advanced HPLC testing: Homogeneity
  • Surface plasmon resonance: Binding kinetics
  • Differential scanning fluorimetry (DSF): Protein stability and protein-ligand interactions
  • Cell bank and viral testing 

Bristol, UK

Our Bristol facility manufactures GMP-grade small molecules and guarantees batch-to-batch consistency, consistency of supply, traceability from starting materials to final product, and animal-free production.

Regulatory Guidelines Followed

  • Relevant sections of ICH Q7 guidelines (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients)
  • USP Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products

 

Certification

 

Quality and Regulatory Support

QC Testing Available

  • Purity
  • Product identification
  • Water content
  • Residue on ignition
  • Residual solvents
  • Solubility
  • Bioburden
  • Endotoxin 

Woburn, MA

We manufacture our Cloudz™ Cell Activation Kits at this facility.

These kits are designed for streamlined activation of immune cells in cell therapy manufacturing processes.

Certification

  • ISO 13485:2016

Inquire About Our GMP Capabilities 

Genome Engineering Services in Minneapolis, MN

We perform GMP cell processing and engineering services at this facility. Our expertise includes genome engineering, reprogramming, differentiation, cell banking, and large-scale production. We handle any cell type including iPSCs and MSCs, cell lines used for commercialization (e.g. CHO, HEK), and primary cells (e.g. T cells, NK cells).

Regulatory Guidelines Followed

  • FDA pre-registered as human cell, tissue and cellular and tissue-based products establishment per 21 CFR 1271

Inquire About Our GMP Capabilities

Newark, CA

In Newark, our Professional Assay Services offer tissue sectioning, ISH staining, high resolution full slide scanning, scoring, and image analysis to support clinical and preclinical studies. Our dedicated team of highly trained specialists, scientists, and board-certified pathologists performs RNAscope™ ISH, BaseScope™ ISH, and miRNAscope™ ISH assays in singleplex, duplex, and multiplex formats.

We operate under Good Clinical Laboratory Practice (GCLP) guidelines which encompass all aspects of individual laboratory operations including sample processing, generation of data, safety and security, employee training, documentation, and sample retention and recovery.

Certification

 

Regulatory Guidelines Followed

  • GCLP compliance according to 21 CFR 820

QC Testing for Our Raw Materials

  • Incoming inspection
  • Visual inspection
  • pH
  • Conductivity
  • Osmolality
  • Enzymatic/end-point activity plate measurements
  • ISH functional types of testing

San Marcos, CA

Our Cliniqa facility provides dynamic, flexible, and regulatory compliant contract services with in-house experts that support manufacturing organizations in the IVD market.

Certifications

  • ISO 13485:2016
  • MDSAP; approval includes US, Canada, Brazil, Japan, Australia

Registrations and Licenses

  • Health Canada Establishment License: 2970
  • USDA Technical Blood Facility, Intermediate Product Facility CA-TEC-0046 and CA-TEC-0053
  • U.S. DEA Manufacturer and Exporter Registration
  • California State Medical Device Manufacturing License: 50393

Service Capabilities

  • Assay development
  • Technology transfer
  • Packaging development
  • Regulatory support
  • Technical support
  • Stability programs

Manufacturing Capabilities

  • Liquid formulation/filling
  • Powder formulation
  • Powder blending and filling
  • Reagent tablets
  • Lyophilization
  • Off-line/in-line labeling
  • Kit assembly/packaging
  • Final product testing

Devens, MA

In Devens, we provide technical and logistical resources for technology transfer and full product development across controls, buffers, calibrators, and standards for the IVD market.

Certifications

  • ISO 13485:2016
  • ISO/CAN 13485:2003
  • ISO 9001:2008

Regulatory Guidelines Followed

  • 21 CFR Part 820
  • 78/79 EC for IVD

Analytical Testing Services

  • HPLC, chemistry, Immunoassays
  • Spectrophotometry
  • Conductivity, viscosity, pH, turbidity
  • Microbiology
  • Preservative efficacy

Stability Testing Services

  • Real-time, transport, open container and accelerated
  • Validated storage capable of -60 °C to +60 °C
  • Environmental control settings of 10-80 %RH
  • Consistent with European standard EN 13640:2002

Analysis and Reporting

  • Protocol generation
  • Method validation
  • Documentation and reporting

Manufacturing

  • Formulaton batch sizes from 15 mL to 1000 L
  • Ampoule filling from 1 mL to 5 mL
  • Pasteurization, autoclaving, irradiation
  • Bottle and vial filling in a multitude of configurations
  • Single use packaging in a variety of configurations
  • Vision systems and weight checks
  • Validation services
  • Detailed documentation
  • Custom design

San Jose, CA

We design, build, and validate ProteinSimple™ analytical instruments for use in clinical manufacturing environments. These instruments operate with 21 CFR Part 11-compliant software that ensures reliability, documentation, and data security.

Our Instruments Provide:

  • Secure access with comprehensive audit/log files
  • User permission controls
  • Automated batch protocols
  • Method-based analysis protocols
  • Automated date and time stamps
  • Unique electronic signatures for each user
  • Protected data repository
  • Comprehensive reporting
  • Electronic audit trail generation

Our 21 CFR Part 11-compliant Instrument Platforms Include: 

  • Simple Western systems for automated, capillary-based immunoassays that combine the power of CE-SDS or cIEF with the sensitivity of immunodetection, enabling size- and charge-based screening of complex sample types.
  • iCE Maurice™ systems for capillary electrophoresis that automates protein profiling by size or charge, employing pre-assembled cartridges and featuring onboard sample mixing.
  • Micro-Flow Imaging for analysis of protein aggregation for stability measurements following stress testing. Up to 90 samples/ run, and up to 150 µL/minute at 900,000 particles/mL.
  • Simple Plex for automated ELISAs to detect fragments and oligomers of cytokines and growth factors with low assay CVs. Single or multianalyte cartridge format options available.

Inquire About Our GMP Capabilities