Why "Wait and See" Isn't an Option
It’s happening…are you ready? As we are coming to the end of Q1 2019, the FDA recently finalized two guidance documents regarding Regenerative Medicine (as of Feb 15, 2019). There is no doubt FDA...
Mon, Mar 11, 2019 | By Lindsay Belcher, Business Development Director - Northeast, Cryoport
It’s happening…are you ready? As we are coming to the end of Q1 2019, the FDA recently finalized two guidance documents regarding Regenerative Medicine (as of Feb 15, 2019). There is no doubt FDA...
Thu, Mar 07, 2019 | By Kirk Randall, Senior Director, Business Development, Cryoport
In choosing a logistics provider and important factor is to find someone who is carrier agnostic. So what does that mean? It means the solution provider is able to use, and track the performance of,...
Mon, Feb 25, 2019 | By Cryoport Team
Precision medicine requires end-to-end traceability: everything from chain of custody, to chain of condition, to chain of identity. But the fragility of regenerative medicine therapies – and the need...
Wed, Feb 20, 2019 | By Sue Blecman, Vice President - Global Strategic Business Development, Cryoport
We’re often asked by our clients what packaging and containment materials should be used to help prevent damage to their shipment contents.In reviewing shipper “packouts” with clients for upcoming...
Mon, Feb 11, 2019 | By Tom Heinzen, VP, Corporate Development & Investor Relations, Cryoport
On January 15th FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D, Director of the Center for Biologics Evaluation and Research released a public statement which outlined new policies...
Wed, Jan 23, 2019 | By Nathan Dai, Senior Director, Business Development, Cryoport
Evaporative cooling uses evaporation from a pocket of fluid to achieve cooling inside a shipping container, often targeting the 2-8°C range. Although it might be useful for situations with less than...
Thu, Dec 20, 2018 | By Soren H. Knudsen, Commercial Director, EMEA, Cryoport
The short answer is: YES!If a specimen or biological material can transition through the freezing point — as happens when frozen in refrigerators and/or packed in dry ice — then holding it at liquid...
Mon, Nov 19, 2018 | By Kirk Randall, Senior Director, Business Development, Cryoport
Dry vapor shipping dewars used for transport of critical temperature-controlled biomaterials and lifesaving materials, such CAR-T and other regenerative medicines, can be purchased and used by...
Thu, Nov 08, 2018 | By Tom Heinzen, VP, Corporate Development & Investor Relations, Cryoport
The global commercial approval of the first CAR-T therapies (Kymriah® and Yescarta®) has intensified the need for the clear and uninterrupted flow of data from before the patient is ever treated to...
Wed, Oct 31, 2018 | By Sue Blecman, Vice President - Global Strategic Business Development, Cryoport
The tedious process of vendor selection for Clinical Trials, Commercialization Planning and Launch in Regenerative Medicine can be daunting, let alone having to think about the Support necessary for...
Wed, Oct 03, 2018 | By Nathan Dai, Senior Director, Business Development, Cryoport
With today’s research collaboration, supply chain distribution, clinical and commercial programs spanning across continents, it is essential for pharmaceutical or biotechnology companies to safely...
Mon, Sep 24, 2018 | By Allie Gerber, Marketing Manager, Cryoport
In December 2016 the US Congress enacted the 21st Century Cures Act, which required the FDA to facilitate an efficient development program for, and expedite the review of, new medicines meeting the...
Wed, Sep 12, 2018 | By Soren H. Knudsen, Commercial Director, EMEA, Cryoport
Moving time and temperature sensitive biological materials “smoothly” across the globe, from A to B, is and requires more than “just” acquiring compliant packaging material and booking a carrier…...
Tue, Sep 04, 2018 | By Ryan Carpentier, Sr. Director, Business Development, Cryoport
When considering your temperature-controlled logistics needs, it is important to think about the compliance consideration steps in the drug development and delivery process being more than just...
Mon, Aug 27, 2018 | By Colin Coffua, Vice President of Strategic Cryoport
Cryoport’s unique range of Cold Chain Logistics Solutions have been developed and implemented to support the most important and advanced drugs currently in the clinical development portfolios of many...
Mon, Aug 20, 2018 | By Kirk Randall, Senior Director, Business Development, Cryoport
In our previous blog we discussed key considerations in the transport of critical biomaterials such as cell and gene therapies, in vitro fertilization shipments or large laboratory bio-sample moves. ...
Thu, Aug 02, 2018 | By Sue Blecman, Vice President - Global Strategic Business Development, Cryoport
Successful research, development, manufacturing and commercialization in regenerative medicine is an epic challenge, with potentially a more epic reward of saving lives.Almost equally challenging is...
Fri, Jul 27, 2018 | By Bruce Bowman, Sr. Director of Channel Sales, Cryoport
Graduating classes of young professionals all over the world are preparing to meet new challenges set before them as the embark on a journey. The lessons and academic content taught in their...
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A Leap Forward in Standardizing the Regenerative Medicine Supply Chain – What the New ISO 21973 Guidance Means for Cell and Gene Therapy Developers
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