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Good Manufacturing Practices in Cell & Gene Therapy

At Bio-Techne, we are proud to take a supporting role in Cell and Gene Therapy (C&GT) 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

Navigate to Other GMP Products Resources

GMP 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.

Quality compliance
CGT lab

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 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.

GMP 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.

Stem cell

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
Genome engineering

What You Can Expect...

  • Consultation with our experts to define the need
  • Refining the project specifics, milestones, and deliverables
  • Regular project updates

Animal-Free Manufacturing Conditions

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.

Commercial cell and gene therapy ebook

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.

Bio-Techne's GMP Facilities

Find out more below about our GMP compliant facilities, dotted across the globe.

Frequently Asked Questions

Inquire About Our GMP Capabilities