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Cryoport Practices Quality by Design (QbD) Approaches When Developing New Products and Processes

Thu, Apr 13, 2017

Cryoport is the industry’s most trusted provider of cold chain logistics solutions for temperature-sensitive life sciences materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. The company stands alone and is truly unrivaled due to their continuous improvement of their products and processes by executing advantageous Quality by Design (QbD) practices in support of their logistics solutions.

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Cancer MoonShot 2020 Initiative Spurs Immunotherapy Research and Integrated Logistics Need

Thu, Jan 19, 2017

Providing $6.3 billion in funding for medical innovation to expedite the discovery, development and delivery of new treatments and cures, the 21st Century Cures Act (Cures) received overwhelming Congressional approval and was signed into law in December 2016.

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Cold Chain Solutions for Autologous Cell Therapy Commercialization

Wed, Dec 14, 2016

Biopharmaceuticals are inherently fragile and temperature-sensitive, requiring exacting control of shipping and storage conditions to maintain product efficacy. This is especially critical for autologous therapies, where cold chain management solutions involving suitable packaging, storage and data collection, as well as tightly controlled logistics, are needed. As companies conduct clinical trials for these innovative therapies, it is the right time to begin building a comprehensive, integrated supply chain in anticipation of product commercialization. 

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Using Real-World Data to Reduce Cold Chain Risk

Wed, Nov 09, 2016

When planning your cold chain logistics strategy for temperature-sensitive biologic materials, a key consideration is minimizing risk to the quality of the commodity and its on-time delivery. Today, there are tools available that optimize outcomes by using real-world data to create better predictive models for the delivery of shipments anywhere in the world.

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Providing a Logistics Management Solution for Biologic Commodity Transport

Thu, Oct 13, 2016

Autologous cell and gene therapy processes start and end with the patient, so the transport and storage of these biologic materials pose complex logistical challenges. Depending on the severity of the patient’s illness, there may be limited opportunities for sample collection and, consequently, manufacture of the potential therapy. Furthermore, any variation in temperature or any interruption in the supply chain, can delay delivery and administration of the therapy to the patient. Irregularities in the cold chain may also affect clinical trial results by compromising data integrity as well as product efficacy and safety. To address these challenges, Cryoport and Database Integrations have launched an integrated solution to manage patient and manufacturer scheduling logistics at every stage of the supply chain for both clinical trial and commercialization processes. 

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Outsourcing Dewar Management to Improve Human and Animal Health Operations

Wed, Sep 28, 2016

Today, an increasing number of therapeutics and vaccines for human and animal administration require shipment in specialized shipping containers often referred to as dewars or cryoshippers. Dewars are composed of an aircraft-grade aluminum exterior that protects an inner holding chamber. The inner chamber is surrounded by a high-surface, low-density open cell plastic foam that retains -196 Celsius for up to 10 days to provide the right conditions for temperature-sensitive materials during transport. Because dewars combine advanced packaging, cryogenics and high-vacuum technology, they can be rather expensive to purchase and maintain. Since they are more expensive than a typical shipping container, such as a Styrofoam or cardboard box, dewars need to be returned for cleaning, reconditioning, testing, revalidation and reuse after each shipment. For companies with large dewar fleets, ranging from hundreds to thousands, ensuring that the dewars are returned can be an especially daunting challenge.

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Cryoport Now Supports Laboratory Relocation

Thu, Aug 11, 2016

Moving a laboratory can be stressful. No matter the scope of the relocation, the logistical and physical act of moving laboratories tends to be an inconvenience that disturbs the flow of information that scientists and researchers seek in their lab spaces. In addition to the hassle, the moving of temperature-sensitive materials and fragile, valuable equipment demands expert care.

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Cryoport and Worthington: What it Means for Your Cold Chain

Wed, Jul 20, 2016

Through our strategic partnership with Worthington Industries, Cryoport will be able to augment our cold chain logistics solutions with the cryogenic transportation and storage equipment Worthington recently acquired from Taylor-Wharton. The partnership gives us an opportunity to introduce storage and fulfillment offerings to provide a wider array of services to clients.

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Cryoport Enters Bio-Storage Market

Wed, Jul 06, 2016

Moving and storing clinical trial therapeutics — such as immunotherapies or regenerative medicines — and biospecimens across the globe are especially complex operations because the materials cannot experience temperature excursions. While frozen materials are shipped and received every day, the logistics and storage of these temperature sensitive materials create new challenges for even the largest and most experienced clinical trial networks and supply chain managers.

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The Growth of the Global Cold Chain

Tue, May 03, 2016

Clinical trials are becoming more global as even the most remote markets are coming within reach. With clinical trial therapeutics being shipped to patients in more countries than ever before, the importance of cold chain logistics management has become increasingly apparent.

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