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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 >


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. Advancements in the rigorous control of the commodity environment have focused in four areas: equipment, refrigerant, IT/data management and analysis, and processes and programmatic integration. In an article in World Pharma Today, Mark W. Sawicki, Ph.D., chief commercial officer of Cryoport, discusses how next-generation biopharmaceuticals can benefit from these developments as well as earlier engagement of supply chain planning in the clinical trial design process. Read more >


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 a narrow range of temperatures during shipment and storage. In an interview with Outsourcing-Pharma.com, Mark W. Sawicki, Ph.D., chief commercial officer of Cryoport, discusses the growing complexities of cold chain logistics, including the need for advanced equipment and processes and adherence to international shipping regulations. Read more >


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 to the Alliance for Regenerative Medicine, there are 70 approved cell therapies currently being marketed and at least 728 ongoing regenerative medicine clinical trials involving thousands of patients for a variety of clinical indications. Although manufacturers go to great lengths to ensure that their highly valuable products are produced under rigorous standards, they may fail to adequately consider these standards when planning the logistics of handling, packaging or transporting materials from one location to another. In this article, Mark W. Sawicki, Ph.D., Cryoport’s chief commercial officer, examines the need for comprehensive cold chain planning for clinical studies in regenerative medicines, and he details current best practices. Read more >


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, Tamie Joeckel, senior vice president of client services and consulting for Cryoport, notes that in addition to strict temperature guidelines, these cellular-based therapies have multi-step supply chains that present a new layer of complexity to scheduling, tracking and tracing because the distribution is also extremely time-sensitive. Learn how these challenges are changing both shipping containers and the sophisticated logistics systems that track them. Read more >