What’s Next For Regenerative Medicine: Regulations—Lots of Regulations
Technology often evolves faster than laws and regulations can keep up, and the field of regenerative medicine is evolving in the same way.
Wed, Apr 10, 2019 | By Cryoport Team
Technology often evolves faster than laws and regulations can keep up, and the field of regenerative medicine is evolving in the same way.
Fri, Apr 05, 2019 | By Soren H. Knudsen, Commercial Director, EMEA, Cryoport
The number of clinical trials is increasing: There are more than 275,000 registered on clinicaltrials.gov, a 26 percent increase from the year 2000.
Tue, Mar 19, 2019 | By Ryan Carpentier, Sr. Director, Business Development, Cryoport
In 2016, Congress passed the 21st Century Cures Act. One of the more important aspects of the Act was to expedite the approval process for new drugs and medical devices. This Act has been a...
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...
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...
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...
Wed, Feb 20, 2019 | By Sue Blecman, Senior Director, 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...
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...
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...
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...
Wed, Oct 31, 2018 | By Sue Blecman, Senior Director, 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...
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...
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...
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...
Thu, Aug 02, 2018 | By Sue Blecman, Senior Director, 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...
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...
Tue, Jul 10, 2018 | By Mark W. Sawicki, Ph.D., Chief Commercial Officer, Cryoport
A carbon dioxide (CO2) shortage has been looming over the life sciences industry — yet many biopharma and biotech leaders alike have remained silent on this issue which is already shaking up our...
Thu, Oct 19, 2017 | By Allie Gerber, Marketing Manager, Cryoport
Cryoport is the leader in cryogenic and cold chain logistics solutions for the life sciences industry with their wide variety of Cryoport Express® dry vapor shippers, unparalleled informatics and...
Wed, Dec 14, 2016 | By Mark W. Sawicki, Ph.D., Chief Commercial Officer, Cryoport
Biopharmaceuticals are inherently fragile and temperature-sensitive, requiring exacting control of shipping and storage conditions to maintain product efficacy. This is especially critical for...
Wed, Nov 09, 2016 | By Mark W. Sawicki, Ph.D., Chief Commercial Officer, Cryoport
When planning your cold chain logistics strategy for temperature-sensitive biologic materials, a key consideration is minimizing risk to the quality of the commodity and its on-time delivery....
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