Transitioning From Research Grade to GMP Reagents
The support you need to transition from preclinical research to clinical trials in your cell therapy manufacturing.
Why Use Animal-Free or GMP Raw Materials?
Research-grade reagents (RUO) are suitable for early discovery work, but entering clinical development requires stricter control over every component in your production process. Trust R&D Systems animal-free and GMP (Good Manufacturing Practice) reagents for:
- Rigorous quality assurance testing to ensure reagent integrity plus lot-to-lot and grade-to-grade consistency
- Full traceability, documentation, and manufacturing controls to ensure regulatory requirements are met
- Greater process standards in a dedicated animal-free manufacturing facility to ensure increased reliability, reproducibility, and ultimately, patient safety
Choose the Right Raw Materials Supplier
A smooth RUO-to-GMP transition depends on a good partnership. Partner with a supplier who understands your process, communicates proactively, and has deep manufacturing and regulatory expertise.
With aligned quality control systems and experienced technical guidance, your move to clinical-grade materials can be straightforward and seamless.
Key Supplier Considerations:
- Expertise in quality management systems and analytical testing
- Manufacturing transparency across all material grades
- Availability of in-person or virtual facility audits
- Regulatory support, including access to Drug Master Files (DMFs) for IND submissions to the FDA
- Proven capacity to scale with your demand
- Ability to tailor solutions to your specific workflow needs
Navigating evolving global regulatory guidelines shouldn't slow you down. Our global Quality Team includes more than 120 experts, ensuring compliance with the latest guidelines and supporting regulatory submissions to all major governing bodies without disrupting your process. Our team over sees:
- Validation of equipment and equipment calibration schedules
- Raw materials inspection, testing, and tracing
- Supplier qualification
- Material review board oversight of variances
- Comprehensive documentation
- Full QA review of batch and bottling records, including bioactivity and endotoxin testing
- Personnel training programs
- Facility maintenance and safety programs
We welcome both on-site and virtual tours and audits of our facilities.
GMP Solutions | ||
GMP ProteinsProtein manufacturing and analytical characterization expertise ensure high quality GMP-grade cytokines.
| GMP Small MoleculesTransition your stem cell therapy or regenerative medicine to GMP with the right grade of small molecules at the right time.
| GMP Human T Cell MediaGMP Media for the expansion and culture of human T cells under xeno-free conditions.
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TcBuster™ Genome EngineeringTcBuster is a next-generation, non-viral genome engineering system for efficient, flexible, and scalable gene delivery across diverse cell types.
| GMP AntibodiesWe can manufacture GMP-grade antibodies recombinantly at gram quantities with enhanced specifications and documentation.
| GMP N-2 Max Media SupplementGMP Animal-free media supplement for ex vivo cell or tissue manufacturing.
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Partner With Us for Your Unique & Custom Needs
Our Custom Team will partner with you to provide flexible solutions exactly tailored to your workflow, from a simple mass adjustment for an existing product to custom development of a new product.
Flexible & Custom Capabilities Include:
- Formulation changes
- Activity-based, mass-based, and liquid vialing
- Batch reservation, supply and quality agreements
- Validation of specialized QC assays
- RUO to GMP conversion
- Custom labeling
- New product development
Custom Case Studies:
- A cell therapy customer partnered with us for their transition to GMP cytokines and to reduce cytokine waste in a closed cell culture system.
- A customer requested the conversion of an existing RUO protein to GMP-grade as well as delivery of the GMP protein at the required scale.
1. Cell and gene therapy manufacturers need to bridge cytokine batches (lot-to-lot consistency, GMP testing against master lot). How can you ensure lot-to-lot consistency and reduce variability?
Cytokines and growth factors are made in biological systems and can be susceptible to variability.
They should only be released to market after successful manufacturing of many consecutive batches that have passed stringent specifications. This builds a solid foundation for future manufacturing consistency and reliability. Manufacturing processes must be controlled with rigorously documented SOPs and highly trained staff. This information should be made available during audit. It is fair to request data from several lots in order to assess a vendor’s ability to manufacture proteins reproducibly. Ideally, materials from multiple lots should be obtained so they can be tested for consistency in your system. At Bio-Techne, we maintain master control lots. Each new bulk lot is compared against the master lot prior to release to market. This reduces variability and ensures consistent product performance.
2. How do you ensure the raw materials you use in your manufacturing are appropriate to make products that can be used for ex vivo manufacturing?
We source raw materials from qualified suppliers with supplier qualification and monitoring systems in place. We also perform risk assessments for critical raw materials used in GMP processes every three years. This includes visual inspection of raw materials with documentation tracking of the Certificate of Analysis (CoA), Certificate of Origin (CoO), TSE/BSE statements, and animal-free statements, if applicable. We perform identity confirmation for some critical raw materials before accepting. For animal-derived materials, we always source from countries considered to be a negligible or controlled BSE risk.
3. What advice would you give to cell therapy developers when sourcing their raw materials?
We advise cell therapy developers to source raw materials from USP-grade or GMP-grade if possible. Our GMP-grade products are manufactured and tested according to applicable standards in United States Pharmacopeia (USP) Section 1043 Ancillary Materials for Cell, Gene, and Tissue-Engineered Products, and European Pharmacopeia (Ph. Eur.) General Chapter 5.2.12 Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products. A supplier should have a certified quality management system (QMS), such as ISO 9001:2015 or ISO 13485: 2016. This means the supplier has been independently audited and has policies and processes in place designed to meet the needs of their customers. Suppliers of these raw materials should be further qualified and monitored by questionnaire, performance of on time delivery, SCARs, and other auditing activities. The Certificate of Analysis, Certificate of Origin and other related documents should be received from each supplier and kept as development and manufacturing records.
You should have early discussions about quality and supply agreements with suppliers to avoid surprises as you progress into production. A manufacturer should have the ability to scale up and meet your future needs in order to avoid late-stage changes that might require costly revalidation.
Identify secondary suppliers early as well. Raw materials may look identical on a Certificate of Analysis but could behave differently in your biological system. Do not assume that you can easily switch between suppliers for a given raw material. Validation studies are required to show equivalency between raw materials from different suppliers.
4. What are ancillary materials?
Ancillary materials (raw materials) are essential components required for the manufacture of cell and gene therapies or tissue-engineered therapies, but they are not intended to be part of the final product. This includes reagents such as small molecules and proteins as well as cell culture media. Although ancillary materials are not meant to be in the final product, they can impact the safety, purity and thus the suitability of the final cell product for clinical use.