How to prepare early for regulatory submissions from IND to BLA
Early Preparation for IND and BLA Submissions Bringing a new cell and gene therapy (CGT) to market is a complex journey, and one that requires rigorous testing and adherence to safety and regulatory standards. At BioLife Solutions, we have supported many drug manufacturers as they prepare for Investigational New Drug (IND) and Biologics License Application […]
Navigating Current Standards and Compliance for Cell and Gene Therapy (CGT) Storage Containers
Adhering to stringent standards for Cell and Gene Therapy (CGT) storage containers is crucial to ensuring product safety and efficacy. From USP guidelines to regulatory requirements, this blog explores how proper materials, container closure integrity, and visual inspection processes safeguard the integrity of CGT products throughout their lifecycle.
Customer Applications of CryoStor® and HypoThermosol® FRS in Cell & Gene Therapy and Regenerative Medicine
CryoStor and HypoThermosol FRS are essential biopreservation media with over 700 applications in cell and gene therapy and regenerative medicine. Used for preserving T-cells, CAR-T cells, stem cells, and more, these solutions support diverse therapeutic and research needs, ensuring cell viability and functionality for cutting-edge treatments and studies.
What COVID Taught Us About the Benefits of Cryopreservation for Cell-Based Therapies
The COVID-19 pandemic significantly impacted various sectors of healthcare, including the blood and biotherapies field. It disrupted the supply and demand for blood and blood-derived cell products, presenting unprecedented logistical challenges that underscored the benefit of cryopreservation for cell and gene therapies (CGT). According to the National Marrow Donor Program (NMDP), cryopreservation of hematopoietic progenitor […]
BioLife Solutions Expands Evidence Library With Citations of Bioproduction Tools in Scientific and Clinical Research
BioLife Solutions’ refreshed Evidence Library offers a comprehensive collection of published data on the use of biopreservation tools in cell and gene therapy. With enhanced navigation and search capabilities, users can easily explore scientific evidence supporting the adoption of products like CryoStor®, HypoThermosol®, and more.
How the BioLife Solutions Master File Letter Request Process Works for CryoStor® and HypoThermosol® FRS
Cross-Referencing BioLife Master Files CryoStor and HypoThermosol FRS (HTS-FRS) are critical components in many customer cell and gene therapy (CGT) and regenerative medicine processes. Although they are not regulated medical products—meaning they are not classified as drugs, medical devices, or marketed/registered as excipients—they serve a critical role as ancillary/raw materials in cell-based manufacturing processes. BioLife […]