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The Emergence of Chain of Compliance™

Mon, Sep 24, 2018

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 definition of a regenerative advanced therapy (RAT) (Section 3033). The RAT designation in the legislation is now referred to as the Regenerative Medicine Advanced Therapy (RMAT) designation.

Now that the first two of these therapies have been approved, the supply chain of patient- and donor-derived regenerative medicine products will fall under increasing pressure for standardization and increased regulatory requirements. Much of the early regulatory focus has been on material processing with four guidance documents issued in a regulatory framework established by the FDA on November 16, 2017, its focus is on recovery, isolation, and delivery. Cryoport believes that enhanced traceability within the temperature-controlled and cold chain logistics distribution will also be subjected to additional regulatory requirements due to the fragile aspect of the drug product and the disproportionate risk of improper cold chain management on the viability of the therapies.

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Tags: Frozen Shipping, frozen shipping solution, Cold Chain Logistics, Cold Chain, Clinical Trials Logistics, Global Cold Chain Logistics, alternative to dry ice shipping, stem cell frozen shipping, regenerative therapies, deep frozen shipping, cellular therapies, temperature controlled logistics, cryogenic shipping, cold chain shipping, biologics, transportation

Are You Securing “Smooth” Compliant Movement of Your Biological Materials?

Wed, Sep 12, 2018

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… While this may seem logic, how are you ensuring visibility to the Chain of Custody, Chain of Condition and more importantly Chain of Compliance™ for your shipment?

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Tags: Frozen Shipping, frozen shipping solution, Cold Chain Logistics, Cold Chain, Clinical Trials Logistics, Global Cold Chain Logistics, alternative to dry ice shipping, stem cell frozen shipping, regenerative therapies, deep frozen shipping, cellular therapies, temperature controlled logistics, cryogenic shipping, cold chain shipping, biologics, transportation

Compliance Considerations Driving Temperature-Controlled Logistics

Tue, Sep 04, 2018

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 getting biologic material from point A to point B.  You need to keep in mind that your distribution needs are just one more integrated step in your business process flow.  In addition, there are a large number of regulations and standards to consider regarding quality and document control, equipment validation, facilities, and personnel—just to name a few.

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Tags: Frozen Shipping, frozen shipping solution, Cold Chain Logistics, Cold Chain, Clinical Trials Logistics, Global Cold Chain Logistics, alternative to dry ice shipping, stem cell frozen shipping, regenerative therapies, deep frozen shipping, cellular therapies, temperature controlled logistics, cryogenic shipping, cold chain shipping, biologics, transportation

Cryoport’s Temperature Controlled Logistics Solutions Supporting Regenerative Medicine Advanced Therapy (RMAT) Clinical Development

Mon, Aug 27, 2018

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 of the leading global biopharmaceutical companies and those that have been commercially approved – Novartis’ KYMRIAH™ and Gilead/Kite’s YESCARTA™. With the criticality of ensuring the highest quality, service and transparency to support the clinical and commercial aspects of each drug, Cryoport provides solutions that provide Chain of Custody, Condition, Identify and most important Chain of Compliance™ ensuring “zero defect” for the transportation and delivery of each lifesaving drug. Cryoport has worked closely with all our client partners to ensure maximum success in a complex environment. The dramatic increase of compounds being investigated in Regenerative Medicine over the last few years has required increased attention to supply chain requirements than ever before. Cryoport is proud to be partnered with the leading biopharmaceutical companies exploring the most advanced medical cures in the world.

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Tags: Frozen Shipping, frozen shipping solution, Cold Chain Logistics, Cold Chain, Clinical Trials Logistics, Global Cold Chain Logistics, alternative to dry ice shipping, stem cell frozen shipping, regenerative therapies, deep frozen shipping, cellular therapies, temperature controlled logistics, cryogenic shipping, cold chain shipping, biologics, transportation

Scientific Conclusions Are All About the Data--Choosing a Logistics Provider For Biomaterial Transport Should Be As Well

Mon, Aug 20, 2018

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.  There we focused on challenges of customs processing, regional or country regulatory requirements and carrier choice and their associated processes.  These are all part of critical risk assessment and mitigation strategies.  Just as the development of the ground-breaking therapies are driven by good scientific methodologies, so should the choice temperature-controlled logistics providers be driven by unbiased data. Whether it be a standard integrator, or a specialty courier, being investigated for utilization data should drive the decision making process.

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Tags: Frozen Shipping, frozen shipping solution, Cold Chain Logistics, Cold Chain, Clinical Trials Logistics, Global Cold Chain Logistics, alternative to dry ice shipping, stem cell frozen shipping, regenerative therapies, deep frozen shipping, cellular therapies, temperature controlled logistics, cryogenic shipping, cold chain shipping, biologics, transportation

Considerations for Successful Biomaterial Transport into Challenging Countries

Thu, Aug 02, 2018

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 working with partners domestically and around the globe to transport temperature controlled materials back and forth to keep progress moving forward.

It seems straightforward enough -  Call your carrier of choice, provide addresses, contact names, documentation about the biomaterials and when you want it to arrive -  simple, right?

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Tags: Frozen Shipping, frozen shipping solution, Cold Chain Logistics, Cold Chain, Clinical Trials Logistics, Global Cold Chain Logistics, alternative to dry ice shipping, stem cell frozen shipping, regenerative therapies, deep frozen shipping, cellular therapies, temperature controlled logistics, cryogenic shipping, cold chain shipping, biologics, transportation

Transporting Life: A Journey of Choice

Fri, Jul 27, 2018

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 respective fields of study still fresh in their minds as they interview for that perfect career. Some of them are hoping to solve age old problems and improve the human condition. The Biology and Life Sciences that they have learned in the classroom is now ready to be put to practical use for a worthy cause – discovery. In this new age of emerging personalized medicine, discovery of new characteristics of living cells is what this generation faces. New opportunities to do research that will be the future of treatments. So how will they transport the needed living cells for their research?

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Tags: Frozen Shipping, frozen shipping solution, Cold Chain Logistics, Cold Chain, Clinical Trials Logistics, Global Cold Chain Logistics, alternative to dry ice shipping, stem cell frozen shipping, regenerative therapies, deep frozen shipping, cellular therapies, temperature controlled logistics, cryogenic shipping, cold chain shipping, dry ice

Webinar Recording: Shipping Frozen Embryos, Eggs and Sperm

Thu, May 21, 2015

Cryoport recently hosted a webinar on shipping frozen embryos, eggs and sperm.  In today’s world, cryogenic shipping is often part of the IVF process.  Sometimes you need to ship frozen embryos, eggs and sperm to a new clinic for additional treatment or to another country where you may be using an international surrogate. This webinar recording answers all of your questions about shipping your frozen embryos, eggs and sperm both domestically and overseas.  The webinar slides are also available.

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Tags: Frozen Shipping, frozen embryo, global IVF, webinar

New Insights into an Age-Old Problem: Aneuploidy

Wed, Mar 25, 2015

Aneuploidy is a condition in which the number of chromosomes in the nucleus of a cell is not the same as the parents. An extra or missing chromosome is a common cause of miscarriages and genetic disorders including human birth defects such as Downs, Klinefelters, and Turners syndromes. For women who would like to wait until their late 30’s or early 40’s to have children the risk of Aneuploidy can exceed 10%. Egg harvesting in a woman’s early 20’s for use later in their reproductive lifecycle has demonstrated an effective means by which to significantly reduce this risk.  A compelling paper describes the risks of pregnancy for women at the end of their reproductive lifespan due to a significant increase in the risk of Aneuploidy. (So I. Nagaoka, 2012). 

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Tags: Frozen Shipping, IVF, sperm, Embryos, Eggs, Aneuploidy

Free Webinar – Shipping Frozen Embryos, Eggs and Sperm

Tue, Mar 10, 2015

In today’s world, cryogenic shipping is often part of the IVF process. Sometimes you need to ship frozen embryos, eggs and sperm to a new clinic for additional treatment or to another country where you may be using an international surrogate.

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Tags: Frozen Shipping, IVF, sperm, Embryos, Eggs, Free Webinar