Cell therapy is revolutionizing the medical world, offering new hope for conditions that once seemed untreatable. To ensure these therapies are both safe and effective, the quality of the raw materials used in their manufacturing is critical—especially when it comes to adhering to Good Manufacturing Practice (GMP) standards.
What are GMP Standards?
GMP comprises a set of regulations and guidelines designed to make sure products are consistently produced and controlled according to quality standards. In the world of cell therapy, GMP isn’t just about ticking regulatory boxes; it’s about ensuring the safety and effectiveness of therapies that rely on complex biological processes.
If the components of a therapy are not GMP compliant, the consistency, quality, and safety of the therapy cannot be guaranteed. This not only leads to regulatory failure but also poses a significant risk to patient safety.
Simply put, GMP assures that cell therapies will consistently perform as intended, offering the reliability necessary for safe and effective treatment.
Why GMP Matters for Raw Materials: Quality, Consistency, and Safety
Let’s dive into why GMP is a non-negotiable when manufacturing raw materials. Here’s a closer look at five key reasons:
1. Staying Compliant
Regulatory bodies, like the FDA and EMA, set strict standards for cell therapies. This ensures that the final product is safe for patient use, with full traceability of all materials, allowing any issues to be quickly identified and resolved. Reagents with Drug Master Files (DMFs) on record help streamline the IND filing process and facilitate smoother regulatory approval.
2. Keeping It Consistent
In cell therapy, consistency is everything. GMP standards ensure that every batch of reagents is as good as the last, which is essential for reproducible results. This consistency is especially crucial when treatments need to be uniform across different production runs for individual patients. Selecting suppliers who offer fully equivalent versions of animal-free Research Use Only (RUO) and GMP reagents can assist in futureproofing cell therapy programs for clinical transition.
3. Minimizing Contamination Risks
The last thing anybody wants is contamination. GMP reagents are manufactured under highly controlled conditions to minimize contamination risk. Rigorous testing for sterility, purity, and performance keeps contaminants out, safeguarding both product quality and patient safety.
4. Supporting Product Efficacy
The success of cell therapies relies heavily on the biological activity of the reagents used. GMP reagents are thoroughly tested to ensure they perform as required in the manufacturing process. This supports the desired cell behavior and therapeutic outcomes.
5. Scaling Up Without Compromising Quality
As you transition from small-scale research to full-scale production, maintaining high quality is imperative. GMP reagents play a key role in this process, guaranteeing that large-scale production adheres to the same stringent standards of quality and safety as smaller-scale operations. Additionally, large lot sizes help maintain consistency across batches, reducing variability and ensuring that your production scales smoothly without compromising the integrity of the final product.
Fueling the Future of Cell Therapy
At Bio-Techne, we’re turning scalability into reality. As the demand for GMP raw materials surges, we’re rising to the occasion.
GMP Cytokines and Growth Factors
Our state-of-the-art, 61,000 sq. ft. animal-free facility in St. Paul, MN, USA is designed to support the large-scale production of GMP, E. coli-derived recombinant proteins. Production takes place in ISO 5/7/8 cleanrooms, adhering to RUO, Medical Device standard (ISO 13485), and Ancillary Material grade GMP (USP<1043>, E.Ph 5.2.12) standards, maintaining the highest levels of cleanliness and quality.
“Bio-Techne has been a world leader in cytokine development dating back to the 1980s with R&D Systems. Our experienced team understands the critical applications served by these proteins, this facility, the people, the processes, and the products, were all brought together with this in mind.”
- Tony Person, Vice President, Proteins Business Unit
Curious about our QC processes? Discover how we maintain our high standards by exploring our quality control practices.
GMP Small Molecules
Small molecules play a crucial role in stem cell therapy development and manufacturing, aiding in cell expansion, guiding cell differentiation, and boosting cell survival rates. At our state-of-the-art chemistry facility in Bristol, UK, we manufacture these vital components with the highest standards of quality. Our dedicated GMP manufacturing team adhere to stringent protocols to ensure that our small molecules provide the robust batch-to-batch reproducibility required for cutting-edge cell therapy manufacture. We are investing in the future by commissioning additional capacity through a new 10,000 sq. ft. purpose-built GMP facility that will begin operations in 2025.
“Small molecules have established themselves as key reagents in the protocols for many of the stem cell-derived therapies currently in development, particularly with in the regenerative medicine field. Our customers have always looked to the Tocris brand to provide industry-leading Quality Control, and now with our range of GMP small molecules, we are enabling our customers to build a new generation of therapies with confidence.” - Rob Felix, Head of Product, Small Molecules Business Unit, Bio-Techne
GMP Cell Culture Media
We’re continually advancing our solutions supporting cell therapy manufacturing. To support robust cell culture processes, we offer GMP media options specialized for T cell and iPSC expansion. These formulations meet the evolving needs in cell therapy by optimizing cell growth and functionality, ensuring top-quality results for your manufacturing processes.
GMP Antibodies
Our latest addition to our GMP portfolio includes GMP antibodies. Specifically designed for T cell activation, these anti-CD3 and anti-CD28 antibodies offer unmatched flexibility, allowing you to optimize activation protocols tailored to your platform and cell types.
GMP Custom Services
When our standard offerings don't quite fit, our custom team steps in to craft solutions that meet your needs. From custom GMP lot manufacturing to packaging, and DMF support, our dedicated teams, including project managers, regulatory experts, and protein scientists, ensure that the final materials meet your exact specifications.