GMP-Ready
Ancillary Materials
Our good manufacturing practices
At BioLife Solutions, we understand the critical role that high-quality raw or ancillary materials play in the successful development and commercialization of cell and gene therapies. Our Good Manufacturing Practices (GMP)-ready reagents and consumables ensure compliance with stringent regulatory requirements while enhancing the safety, consistency, and efficacy of your bioproduction processes.
Why choose GMP-ready materials?
Regulatory agencies worldwide, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), emphasize the importance of using regulatory-ready raw or ancillary materials in biopharmaceutical manufacturing. By utilizing GMP-ready products from BioLife Solutions, you can:
- Streamline Regulatory Approvals – Reduce risk and accelerate Investigational New Drug (IND) and Biologics License Application (BLA) submissions
- Ensure Consistency & Quality – Maintain batch-to-batch reproducibility and product integrity
- Enhance Process Efficiency – Minimize contamination risks and variability in production
Our portfolio of GMP-ready products
BioLife Solutions offers a wide range of GMP-ready products tailored to meet the rigorous demands of cell and gene therapy manufacturing. Our portfolio includes:
- CryoStor® Cryopreservation Media – Optimized for preserving cell viability during cryogenic storage and transport >
- HypoThermosol®FRS Biopreservation Media – Designed to extend the stability and shelf-life of cellular products at 2-8°C >
- Stemulate®-CP Human Platelet Lysate – An alternative to Fetal Bovine Serum (FBS) for cell culture of multiple cell types >
- nLiven® PR & T-Liven® PR Human Platelet Lysates – Irradiated GMP-compliant supplements for expansion of multiple cell types >
- CellSeal® Vials – Closed, cryocompatible primary storage containers and closed-retrieval intermediate product storage vials >
This list is not comprehensive. Please reach out to a BioLife Solutions representative if you have additional questions.
Regulatory support and master files
To facilitate seamless regulatory submissions, BioLife Solutions maintains Master Files with the FDA for our GMP-ready materials. Customers can reference these Master Files by requesting a Letter of Authorization (LOA), eliminating the need for redundant documentation and expediting regulatory reviews.
Partner with BioLife Solutions
Choosing the right ancillary materials is essential for regulatory success and product consistency. BioLife Solutions is committed to providing high-quality, GMP-ready materials that support your manufacturing workflow and regulatory journey.
Enhance your therapeutic development process
Contact us today to learn more about how our GMP-ready ancillary materials can benefit your therapeutic development process.
Safety Data
Sheets
Certificate
of Analysis