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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 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>


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 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 >


Intelligent Logistics: Key Considerations of Manufacturing Biologics

September 21, 2017

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 >


Cold Chain Market and Technology Trends

September 06, 2017

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 >


The Arrival of Quality by Design in Logistics

April 25, 2017

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 >


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 impact on the development, clinical performance and commercialization success of advanced drug therapeutics. In a recent Applied Clinical Trials article, Robert L. Moore, Ph.D., Sales Director at Cryoport, discusses these logistical impacts as well as a bioanalytical study that investigated packaging, refrigerant and real world logistics effects on the quality of bioanalytical material as measured by biomarker recovery in human plasma samples and cell-viability using a GMP working cell bank. Read more >


Risky Move

February 24, 2017

When transporting temperature-sensitive regenerative therapies, companies can mitigate risk by employing a Supply Chain Quality by Design (SC-QbD) process during clinical and commercial distribution. By leveraging innovative shipping technologies, including continuous monitoring, the industry can achieve better visibility into the dynamic handling and condition of the biologic material and its packaging throughout its journey. In a recent article in International Clinical Trials, Mark W. Sawicki, Ph.D., chief commercial officer of Cryoport, discusses how real-time data provides significant analytical tools for actionable Design of Experiment and QbD methodologies that will ultimately protect the quality of the material transported and the resultant data. Read more >


Biostorage: Closing the Loop in Biopharmaceutical Supply Chain Management

January 03, 2017

The complexity of shipping and storing temperature-sensitive biologics creates cold chain challenges. However, these risks can be mitigated when advanced packaging, data monitoring and biostorage are integrated with logistics systems that provide end-to-end visibility and control of the process. In a recent article in Pharmaceutical Outsourcing, Mark W. Sawicki, Ph.D., chief commercial officer of Cryoport, addresses key considerations when selecting a partner to handle both shipment and biostorage, including adherence to best practices and verifiable storage and fulfillment capabilities. Read more >

IT and Logistics Solutions for Animal Vaccine Distribution

December 07, 2016

Animal vaccines are essential, not just because they can effectively prevent potentially serious diseases in animals, but also they can be beneficial to humans’ health. In an International Journal of Animal Health article, Kirk Randall, Sales Director at Cryoport, addresses the most pressing issues regarding the cryogenic logistics and shipment of cryogenic animal health products as they represent the highest level of need, both in terms of capital and shipping expense-related costs, for any organization working with these products. Read more > 


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 complexity of the process for these therapeutics, where patient scheduling plays a key role in the timing and sequencing of shipments. In a Pharmaceutical Manufacturing article, Mark W. Sawicki, Ph.D., chief commercial officer of Cryoport, discusses how integrated logistics systems can provide solutions for optimizing shipments, monitoring the condition as well as the location of materials and coordinating purpose-built packaging. Read more >