Articles

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 of Cryoport in a recent Outsourcing-Pharma feature. Read Full Article >

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 life-threatening conditions, including genetic disorders and cancer. The logistics and supply chains for these therapies, particularly those that involve the manipulation of autologous cells, can be complex, and there are many points in the chain in which the cells are vulnerable to accidental diversion or temperature deviation. In a recent feature in BioPharma Dealmakers, the importance of Chain of Compliance™ is revealed and explained:  Read Full Article >

Find out why the life science temperature-controlled space continues to grow apace in Asia Pacific and how supply chains can keep up with every-complex demands in a recent ASIA Outlook article by Mark W. Sawicki, Ph.D., Chief Commercial officer of Cryoport:  Read Article >

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 of these therapies. In a recent World Pharma Today featured article, Mark W. Sawicki, Ph.D., Chief Commercial officer of Cryoport, discusses the emerging Chain of Compliance^TM requirements for regenerative medicine distribution. Read more >

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. Sawicki, Ph.D., Chief Commercial officer of Cryoport, discusses why the Chain of Compliance™ is critical to winning in the RMAT market.  Read more >

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 article in Wired Magazine that discusses Cryoport and their role in delivering critical cancer therapies. Read more >

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 cells, and CAR-T cells. Cryoport's goal is to help simplify global cold chain logistics through innovative technollogy, unmatched monitoring and data capture and support for the life sciences industry. In a recent Contract Pharma article, Mark W. Sawicki, Ph.D., Chief Commercial officer of Cryoport, discusses the importance of Cryoport's leading-edge logistics services for the safe delivery of temperature-sensitive personalized medicines. Read more >

"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 Security act come into force," Mark W. Sawicki, Ph.D., Chief Commercial officer of Cryoport, discusses validation standards and pharmaceutical logistics as biotechnology advances in a recent article in Pharmaceutical Outsourcing. Read more >

"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 uses specifically developed Cell Therapy Systems (CTS) Dynabeads technology, part of Thermo Fisher's  CTS portfolio. The magnetic beads isolate, activate and expand T cells that have been genetically engineered to recognize and fight cancer cells in each individual patient.
 
Recently, Kite Pharma received approval from the FDA for Yescarta, a CAR T therapy for the treatment of relapsed or refractory large B-cell lymphoma. Kite, headquartered in Santa Monica, CA, was recently acquired by Gilead for approximately $11.9 billion.
 
Cryoport, a provider of cold chain logistics for temperature-sensitive life sciences materials, is the logistics shipper for both of these products, which represent the first two commercialized CAR-T cell therapies now available for patients. Jerrell Shelton, Cryoport’s chief executive officer discusses the processes and technologies associated with supporting logistics for CAR-T therapies."  Read full article in Contract Pharma>

"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 patients. That’s where logistics companies like CryoPort, Inc. come into play. CryoPort has consistently been one of the top cryogenic logistics companies serving the life sciences industry and that is only likely to continue. In May, the company reported robust financial growth driven by biopharma. That type of growth it likely to maintain for some time.

CryoPort handles the products for more than 172 of the more than 800 immunotherapy trials underway. CryoPort is the logistics provider for 17 Phase III trials and 199 trials in the regenerative medicine. The company also secured the logistics contracts for Novartis Pharmaceuticals Corporation’s Kymriah and Kite Pharma(now Gilead’s) Yescarta, the first two commercialized CAR-T cell therapies that were approved earlier this year." Read full article in BioSpace >