Cryoport Talks Compliance, Biopharma Expansion, and Brexit - Outsourcing-Pharma

November 13, 2018

Securing the clinical supply chain comes down to the notion of ‘compliance’, which is transitioning from a ‘nice to have’ to a ‘need to have,’ says Mark W. Sawicki, Ph.D., Chief Commercial officer...

Building an unbreakable Chain of Compliance™ - BioPharma Dealmakers

November 05, 2018

Regenerative medicine advanced therapies in the form of cell and gene therapies are breaking new ground, providing patients the potential of treatment, reversal or even cure of serious and...

Quality Systems for Regenerative Medicine Delivery; Basic Quality Requirements for Distribution - World Pharma Today

August 20, 2018

The emergence of regenerative medicine as a viable therapy class has created an urgency to review and improve upon the current quality systems distribution standards that are employed in support...

The Chain of Compliance™ - Contract Pharma

June 14, 2018

Chain of Compliance™ is vital for the Regenerative Medicine Advanced Therapy (RMAT) market which presents a major opportunity for the industry. In a recent Contract Pharma article, Mark W....

Exclusive interview with Cryoport CEO - Gasworld

April 10, 2018

Gasworld spoke to Jerry Shelton, Cryoport’s CEO, to find out how the latest regenerative medicines wouldn’t be possible without an often overlooked, yet extremely important component: logistics.s. 

Inside the Company Delivering the Next Generation of Cancer Therapies - Wired Magazine

March 05, 2018

When it comes to shipping CAR-T cells, there are many factors that come in to play in order for drug companies to successfully mitigate risk – that’s where Cryoport comes in. Check out a recent...

The Logistics Behind Personalized Medicine Delivery - Contract Pharma Article

February 21, 2018

Cryoport serves the biopharmaceutical market with leading-edge logistics solutions for biologic materials to ensure a safe delivery, such as regenerative medicine, including immunotherapies, stem...

Understanding Pharmaceutical Logistics Validation in a Dynamic Environment - Pharmaceutical Outsourcing

February 12, 2018

"Emerging technologies such as regenerative medicine will only increase the complexity of the logistics systems that need to be validated, especially as the requirements of the Drug Supply Chain...

CAR-T Supply Chain Logistics - Contract Pharma Article

November 06, 2017

"This past August, the FDA approved the first chimeric antigen receptor T cell (CAR-T) immunotherapy, Novartis’ Kymriah for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL). It...

Cryogenic Logistics Company Cryoport Grabs Contracts for Gilead, Novartis CAR-T Products - BioSpace Article

November 03, 2017

"In the world of developing and manufacturing cell-based therapeutics an approved medication for any indication is only part of the business plan. The other aspect is delivering the product to...

Packaging, IT and Cold Chain Logistics Advances for the Future of Medicine and Clinical Trials

March 01, 2017

Many industry experts believe the most significant advancement for the future of medicine and clinical trials logistics is the realization that logistics has a direct and measurable scientific...

Cold Chain Planning: An Integrated Approach

December 03, 2016

CAR T-cell therapy, immunotherapy and other autologous cellular therapies require an integrated approach for their manufacture, shipment and storage. The need for integration is largely due to the...

Logistics Advancements and Trends in the Biopharma Industry

December 01, 2016

For successful commercial distribution, advanced cellular therapies require secure, well-designed cold chain management solutions based on effective packaging, informatics and logistics expertise....

Cold Chain Challenges Evolving With Industry

November 23, 2016

To ensure the safety and efficacy of inherently fragile regenerative medicines and other temperature-sensitive clinical trial therapeutics and biospecimens, the materials must be maintained within...

Cold Chain Planning for Regenerative Medicine Clinical Studies

November 01, 2016

The advent of regenerative therapy — a field that includes gene therapy, gene editing, stem cell therapy and immuno-oncology — is creating an unprecedented need for cold chain logistics. According...

It’s Never Too Early for Cold Chain Planning for Cellular Therapies

October 01, 2016 New cellular therapies underscore the complexity of cold chain logistics with new requirements that may be unfamiliar to even experienced supply chain managers. Writing in Applied Clinical Trials,

Supply Chain Challenges with New Therapies

July 07, 2016

Supply chains for many regenerative therapies can be very complex. Where traditional pharmaceuticals have linear supply chain models, autologous cell therapies oftentimes require circular supply...

Cryogenic Gas Solutions Drive Regenerative Therapies in Life Sciences

June 06, 2016

Innovation in the pharmaceutical industry is being led by regenerative therapies. Many of these new therapies need to be maintained at cryogenic conditions during storage and transport and cannot...

How Cold Chain Logistics Work in Clinical Trials

November 17, 2015 In this exclusive article for Applied Clinical Trials, Cryoport Chief Commercial Officer Mark Sawicki, Ph.D. , discusses the importance of reliable, environmentally controlled cold chain...