Articles

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 >

The pharmaceutical industry faces many challenges when manufacturing biologics in a commercial environment. Since manufacturing is being increasingly outsourced, cell bank production, maintenance and distribution logistics have become profoundly critical. In a European Pharmaceutical Manufacturing (EPM) Magazine article, Dr. Robert Moore, Sales Director of Cryoport, discusses the key considerations of manufacturing biologics in a commercial environment and the benefits of implementing intelligent logistics . Read more >

The cold chain pharmaceutical market continues to be one garnering specific interest within the logistics space. New therapies such as regenerative therapies and gene therapies as well as a shift toward temperature-managed shipments are currently of significant focus. This is due to many therapeutics being close to commercial launch and the need to be shipped under very exacting temperature conditions. The Drug Supply Chain Security Act (DSCSA), along with FDA 21 CFR GMP and GDP requirements, have also turned a spotlight on the value of these intelligent temperature-controlled materials requiring better and safer transportation solutions. Many companies have turned their focus on three primary areas to respond to these requirements; namely enhanced, reusable packaging, real-time data monitoring, as well as advanced informatics systems to support in transit logistics considerations. In a Contract Pharma article, Mark W. Sawicki, Ph.D., Chief Commercial officer of Cryoport, discusses each of these areas independently in great depth.  Read more >

Quality by Design (QbD) is a concept that has become mainstream in the pharmaceutical manufacturing space in recent years. The QbD concept within cryogenic logistics cannot be implemented without an in-depth understanding of the equipment and processes by which critical pharmaceutical commodities are packaged and shipped. In a World Pharma Today article, Mark W. Sawicki, Ph.D., Chief Commercial officer of Cryoport, discusses how QbD in cold chain logistics incorporates modern tools to preemptively understand and ultimately work to control variation. Read more >