The Silent Threat in Cell Therapy Development: Transient Warming Events
Protecting Cell Therapy Quality by Preventing Transient Warming Events As cell and gene therapies continue to gain traction, the industry’s focus on automation, digital transformation, and advanced manufacturing platforms is stronger than ever. But in the midst of these innovations, one often overlooked challenge can quietly compromise therapy outcomes: Transient Warming Events (TWEs). At The […]
The Cell Summit ’25 Frequently Asked Questions (FAQs)
Everything You Need to Know Before The Cell Summit ’25 As we gear up for The Cell Summit ’25, we want to make sure you have all the details you need to plan your trip, navigate the event, and make the most of your time in Indianapolis. From hotel and shuttle logistics to what to […]
Meet the Makers: Innovations and Insights from The Cell Summit ’25
Voices from the Lab: Breakthroughs and Best Practices from The Cell Summit This August, leaders across the cell and gene therapy (CGT) industry will gather in Indianapolis for The Cell Summit ’25, hosted by BioLife Solutions. Designed as a dynamic forum for knowledge-sharing, product exploration, and problem-solving, this event brings together voices shaping the next […]
Designing the Ideal Cryostorage Container for CGT
Celebrating Innovation: The CellSeal CryoCase One Year Later Since its launch at the 2024 ISCT Annual Meeting, the CellSeal® CryoCase is poised to become a cornerstone solution for Cell and Gene Therapy (CGT) and biopharmaceutical storage. Designing this ideal cryostorage container involved precise engineering and deep industry understanding. This innovative design represents significant advancement in […]
The Cell Summit ’25: A Must-Attend Event for Innovators in Cell & Gene Therapy
Join the Premier Cell and Gene Therapy Manufacturing Summit of 2025 WHEN: August 5–6th WHERE: Newfields Art Museum, Indianapolis, IN In the ever-evolving field of cell and gene therapy, the pressure to scale, preserve, and commercialize cell-based products has never been greater. That’s why BioLife Solutions, Azenta Life Sciences, and Entegris have partnered to bring […]
Optimizing Biopreservation Strategies for Apheresis-Derived Cells in Immunotherapeutic Applications
As immunotherapies continue to transform patient care, the biopreservation of apheresis-derived cells plays a vital role in ensuring consistency and quality. This blog explores how advanced preservation strategies—such as optimized cryopreservation and hypothermic storage—help reduce variability, protect cell function, and support the scalable manufacturing of cell-based therapies.
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 […]