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CSafe Elevates Cell and Gene Therapy Transport with Reusable Cryogenic Solution

CSafe Elevates Cell and Gene Therapy Transport with Reusable Cryogenic Solution

CSafe, an active and passive temperature-controlled shipping solutions provider for the biopharmaceutical industry, proudly announces the launch of a new line of cryogenic multi-use dewars for the cell and gene therapy market. The progressive technology, which is the first in CSafe’s CGT Cryo Series, maintains temperatures colder than -150°C.

The reusable dewars and high-impact-resistant shipping cases are engineered to securely transport critical cell and gene therapies, including pre-frozen biologic materials, regenerative medicine, immunotherapies, stem cells and CAR-T cells.

“The cell and gene therapy industry needs more solutions that integrate data with products, alongside a global network with advanced capabilities and service infrastructure,” said Patrick Schafer, CSafe CEO. “Our team has worked tirelessly to develop these new solutions to ensure the integrity of our customers’ valuable cargo, and ultimately provide peace of mind.”

These cutting-edge solutions offer a myriad of key features tailored to meet stringent industry standards. Pre-conditioned using liquid nitrogen, these dry vapor units boast an impressive hold time of 10+ days against the ISTA 7D thermal profile, providing high levels of reliability for critical shipments. They include built-in TracSafe RLT real-time data tracking devices to monitor internal product temperature, external ambient temperature, shock, tilt, and location throughout the shipment journey. Through CSafe Connect, the company’s digital portal, customers can easily track their order, access real-time data, and upgrade to the premium Control Tower shipment monitoring service for added monitoring and control.

Additionally, the multi-use dewars deliver extra protection with security seals and a lockable shipping case to prevent tampering during transit. The dry vapor unit complies with IATA Dangerous Goods Regulation, and the shipping case’s domed cap prevents stacking to ensure a stable, upright orientation during transit and handling. Qualified to industry standards, including ISTA 3A for distribution and ISTA 7D for thermal qualification, these high-performance solutions offer peace of mind for customers.

“Our new line of dewars isn’t just a product—it’s a promise,” said Emilio Frattaruolo, Vice President, Cell & Gene Therapies. “A promise of precision and reliability as we venture into the next frontier of innovation in cell and gene therapies.”

CSafe unveils cutting-edge innovations to meet cold chain customer needs

CSafe unveils cutting-edge innovations to meet cold chain customer needs

CSafe, a leading active and passive temperature-controlled shipping solutions provider for the biopharmaceutical industry, announces it is launching three new technologies at the international LogiPharma 2024 event, which takes place April 16-18 in Lyon, France. The products build upon CSafe’s comprehensive, data-leveraged portfolio of solutions, integrating real-time data tracking to ensure maximum visibility and confidence throughout the shipping journey.

“2024 marks a bold year of innovation for CSafe—we’re redefining the landscape of cold chain logistics,” said Patrick Schafer, CSafe CEO. “We’re constantly listening to our customers, and that ensures we’re able to meet their current needs and anticipate and address their future challenges.”

CSafe’s new technologies address the most pressing challenges that pharmaceutical companies and other key players in the cold chain industry face today.

CSafe’s Multi-Use Dewars, the first in the CGT Cryo Series, are designed to serve the quickly growing cell and gene therapy market. These cryogenic, reusable dewars maintain the coldest temperature range of any dewar available on the market, -150°C or colder. This cutting-edge technology uses liquid nitrogen dry vapor units and includes a built-in TracSafe RLT real-time data tracking device.

CSafe Connect Control Tower, the company’s new white-glove shipment monitoring service, provides customers with ultimate visibility into real-time shipping data such as GPS location, cargo temperature and more. The company’s dedicated service team monitors shipments 24/7/365 to identify and escalate potential temperature deviations or issues to the appropriate stakeholders. The service also includes shipment creation and preconditioning, as well as reporting upon shipment delivery.

Silverpod MAX RE is CSafe’s newest reusable shipping solution, designed to help customers meet their sustainability targets. An evolution of CSafe’s flagship Silverpod technology, the Silverpod MAX RE is a highly durable pallet shipper made entirely of reusable components. It uses high-performing, recyclable PCM coolants to enable safe storage before and during shipping and provides 120+ hours of qualified thermal protection. An integrated real-time tracking device offers customers the ultimate in shipment visibility.

CSafe is known for being a trusted provider of temperature-controlled and digital solutions that help life science organizations protect and transport critical, life-enhancing products, anywhere in the world. The addition of its latest products strengthens its comprehensive portfolio of offerings, and underscores its commitment to meeting customer demands through creative solutions.

“We’re paving the way for solutions that set high standards in the industry and, above all, elevate the customer experience,” said Tom Weir, CSafe COO and CTO. “These new products signal that we’re innovating for what’s next.”

The company holds numerous patents, and its latest round of innovations continue to push boundaries that set it apart from competitors. Recently, the patented designs for CSafe’s air cargo containers have been upheld by the United States Patent and Trademark Office (USPTO), reaffirming the novel and innovative nature of CSafe’s inventions.

CSafe Expands Global Network Further into India with Bangaluru Station

CSafe Expands Global Network Further into India with Bangaluru Station

CSafe has partnered with WFS in Bangaluru to provide active temperature-controlled containers locally for pharmaceutical shipments at WFS Coolport

CSafe, the largest active and passive temperature-controlled shipping solutions provider for the biopharmaceutical industry, has opened a new station in Bangaluru to provide active temperature-controlled containers locally.

This latest CSafe station in India follows the opening the company’s Hyderabad location in late 2022. With a second CSafe station operational in India, customers have more options for shipping temperature-controlled pharmaceuticals into and out of the country.

CSafe partnered with WFS in Bangaluru to make active air cargo units available at their Kempegowda International Airport facility. WFS, a member of the SATS Group, operates two cargo terminals at Bengaluru including WFS Coolport which is the exclusive gateway for all temperature-controlled cargo moving via Bengaluru Airport. The CSafe station at Bengaluru Airport is located inside WFS Coolport’s premises, allowing containers to move in and out of the country much faster. CSafe RKN and RAP containers will be available for pick-up and return through the new facility.

For more information on leasing CSafe containers from our Bangaluru location, contact Ravindra Rao at rrao@csafeglobal.com.

Central Pharma joins CSafe’s network of partner pharma service providers to expand supply chain solutions for the cell and gene therapy market

Central Pharma joins CSafe’s network of partner pharma service providers to expand supply chain solutions for the cell and gene therapy market

Bedford UK and Monroe, OH – May 24, 2023 – CSafe, the largest active and passive temperature-controlled shipping solutions provider for the biopharmaceutical industry, and Central Pharma, a specialized service provider of manufacturing, packaging and storage for the cell and gene therapy (“CGT”) and broader biopharma markets, announced today a new partnership to provide a complementary service network to support CGT products.

The new partnership will provide expanded supply chain options for any CGT product, at any stage of development, with an initial focus on the UK and European markets.

Operating from more than 75 locations worldwide, CSafe is a proven, trusted partner for biopharmaceutical manufacturers seeking to navigate cold chain complexity, with a track record that includes precise temperature-controlled shipping of more than six billion doses of a leading COVID-19 vaccine, and 99.9% reliability across its cold chain portfolio. Central Pharma operates across UK and European markets with advanced AI software used within their specialist capabilities. From clean-room kitting to GMP filling and packing, they support warehousing storage and specialty logistics for a growing number of partners in the CGT industry.

“CSafe is excited to deepen our capabilities to serve the rapidly growing CGT market in collaboration with Central Pharma,” said CSafe CEO Patrick Schafer. “Central Pharma has earned the confidence of key CGT developers in the UK and the EU, with plans to expand their core capabilities to other markets. We know how important these therapies are to patients everywhere, and it’s our mission at CSafe to protect every shipment.”

“We’re excited to collaborate with CSafe in a sector we are deeply passionate about serving – the CGT market,” said Central Pharma CEO Alwyn Smit. “Leveraging CSafe’s consistent 40 year-history of reliability and performance, and the company’s full range of cold chain solutions, will only enhance our support for patient protection in the most complex and innovative area in medicine.”

CSafe Further Expands Its Digital Ecosystem with Enhancement of CSafe Connect and Launch of TracSafe Data Logger Suite

CSafe Further Expands Its Digital Ecosystem with Enhancement of CSafe Connect and Launch of TracSafe Data Logger Suite

CSafe Connect enables a truly connected supply chain by bringing together product ordering, shipment analytics and customer support under a single login

MONROE, Ohio, January 10, 2023 – CSafe, a leading provider of a complete range of active and passive temperature-controlled shipping solutions for the pharmaceutical industry, announced today the launch of CSafe Connect and its new TracSafeTM line of data loggers, advancing to the next frontier of CSafe’s customer-focused digital ecosystem.

CSafe Connect is a recent evolution of CSafe’s cloud-based customer portal through which CSafe customers can place orders, track and manage shipments in real-time, log a support ticket, chat live with support staff, download product data resources and access web-based training.

CSafe Connect’s shipment tracking and analytics are enabled by the TracSafe suite of data loggers, available for single-use, reusable and real-time applications in most CSafe solutions including: CSafe RKN, CSafe RAP, CSafe APS, Softbox VIP and CGT Ultra parcels. The integrated data loggers and real-time analytics will be implemented across the remaining Softbox parcel and Silverpod pallet shipper lines later this year.

“We initiated this digital transformation journey three years ago and have kept a keen eye on the future as we continue developing this new cold chain digital ecosystem. What we are launching today is the next logical iteration of our offering and promise to provide customers what they need to ensure critical medicines are kept safe during their journey to patients,” said Patrick Schafer, CEO CSafe. “The combination of products, services and tools we offer today has the power to reduce customer product loss, create operational savings, increase speed of delivery and improve decision-making ability. And that’s just the beginning. We are committed to raising the bar for predictive insights, integrated decision-making and enhanced reliability across the pharma cold chain. I am excited about what we have planned for in 2023 and beyond.”

CSafe Expands Global Network Further into India with New Service Station in Hyderabad

CSafe Expands Global Network Further into India with New Service Station in Hyderabad

CSafe has contracted with GMR in Hyderabad to provide active temperature-controlled containers locally for pharmaceutical shipments

MONROE, Ohio, November 17, 2022 – CSafe, one of the largest providers of a complete range of active and passive temperature-controlled shipping solutions for the pharmaceutical industry, held a grand opening celebration for the company’s new Hyderabad service station on Nov. 11, 2022.

India’s recent investment and commitment to the pharmaceutical industry via the planned Pharma City development in Hyderabad which is poised to be the world’s largest integrated pharma cluster demands consistent access to top quality temperature-controlled shipping solutions. “This is a monumental undertaking in India and one that we at CSafe are thrilled to support with a new local station to supply our high-performing RKN and RAP containers to the industry,” said CSafe Chief Commercial Officer, Seth Hertel. “The health care and life sciences market has been growing substantially over the past years in Hyderabad. The work at Pharma City will only increase that focus, which would underscore the need for a local presence by CSafe.”

CSafe partnered with GMR in Hyderabad to make active RKN and RAP containers available at the Hyderabad International Airport. The station was inaugurated by Honorable Chief Guest Shri. Jayesh Ranjan IAS, Principal Secretary to the Government of Telangana.

The celebration event attended by local pharmaceutical and logistics executives included product demonstrations, dinner and presentations from CSafe executives including Ravindra Rao, Director of Life Science Sales – India and Scott Garchar, Global Vice President – Active Sales.

For more information on leasing CSafe containers from our Hyderabad location, contact Ravindra Rao at rrao@csafeglobal.com.

CSafe Continues Expansion of Its Temperature-Controlled Shipping Solutions Portfolio with Introduction of Advanced Reusable Pallet Shipper

CSafe Continues Expansion of Its Temperature-Controlled Shipping Solutions Portfolio with Introduction of Advanced Reusable Pallet Shipper

Loaded with innovation and technology, CSafeAPS provides superior temperature control and the industry’s only in-transit thermal capacity indicator

MONROE, Ohio, October 18, 2022 – CSafe, the largest provider of a complete range of active and passive temperature-controlled shipping solutions for the pharmaceutical industry, announced today the launch of its new advanced reusable pallet shipper, CSafeAPS.

The new CSafeAPS was engineered to provide reliable and customizable thermal protection at ambient, refrigerated and frozen temperatures. Rigorously tested against the most challenging ISTA 7D profiles, the CSafeAPS provides continuous protection for more than 120 hours.

In addition to delivering the highest level of thermal protection in a passive pallet shipper, the CSafeAPS features real-time data tracking of GPS location, cargo and ambient temperature, ambient humidity and pressure, shock, tilt and door open/close events. CSafe’s proprietary cloud-based shipment visibility platform enables live monitoring throughout the entire shipping journey, including the thermal capacity indicator, which displays the predicted remaining temperature protection by lane, providing risk mitigation and peace of mind that the product will reach the end destination uncompromised.

CSafeAPS was also designed with ease-of-use in mind. All units are delivered preconditioned, for simple load-and-go functionality. The unit is forkliftable from all sides and is optimized to fit four pallets of product on a standard wide-body cookie sheet with a double pallet.

“CSafe is committed to providing shipping solutions that meet the full range of pharmaceutical cold chain shipping needs,” said CSafe CEO Patrick Schafer.  “From large volume diabetes drugs to small parcel vaccine shipments to ground-breaking individual cell & gene therapies, CSafe can provide the optimal solution to ensure medicines reach the patients who need them. Our CSafeAPS is another example of how we saw a need in the market and applied our industry-leading engineering and quality assurance expertise to deliver a solution with more advanced technology, ease of use and reliability than any other passive solution available today.”

CSafe and BioLife Solutions, Inc. announce partnership to expand supply chain solutions for the cell and gene therapy market

CSafe and BioLife Solutions, Inc. announce partnership to expand supply chain solutions for the cell and gene therapy market

CSafe joins BioLife’s global partner network of cold chain solution providers using the evo® cold chain management platform

MONROE, Ohio and BOTHELL, Washington, Oct. 11, 2022 – CSafe, one of the largest active and passive temperature-controlled shipping solutions providers for pharmaceuticals, and BioLife Solutions, Inc. (NASDAQ: BLFS), a leading supplier of class-defining bioproduction tools and services for the cell and gene therapy (“CGT”) and broader biopharma markets, announced today a new partnership to provide a combined global service network to support CGT products, with a focus on enhanced reliability, security and quality.

CSafe joins BioLife’s global partner network of cold chain solution providers serving the CGT market. BioLife expects to support 10,000-12,000 evo shipments of CGT starting materials and manufactured doses over the next 12 months. The new partnership will provide expanded supply chain options for any CGT product, at any stage of development, from early clinical-phase trials to global commercial scale.

CSafe will bring even more of its highly reliable global reach to the CGT sector through this new alliance. Operating from 50+ service centers worldwide, the company is a proven, trusted partner for biopharmaceutical manufacturers seeking to navigate supply chain complexity, with a track record that includes shipping solutions for six billion doses of a COVID-19 vaccine.

“CSafe is honored to partner with the team at BioLife Solutions, whose range of CGT bioproduction tools and services is peerless in the market. We are excited to merge these exceptional tools and services with our expertise in global, reliable scaled delivery,” said CSafe CEO Patrick Schafer. “CGT is hitting its stride and needs global support. We know how important these therapies are to patients everywhere, and it’s our mission at CSafe to protect every shipment.”

“We’re excited to work with a global partner with a strong history of reliability and performance and a deep dedication to innovative therapies,” said BioLife Solutions CEO Mike Rice. “We have the best LN2 technology and cGMP storage facilities in the market, in addition to our other world-class CGT solutions, and we are confident our collaboration with CSafe will extend our reach and result in even more reliability and real-time service for CGT partners.”

CSafe Global Continues Investment in Cell and Gene Therapy Solutions with Addition of New Portfolio President

CSafe Global Continues Investment in Cell and Gene Therapy Solutions with Addition of New Portfolio President

MONROE, Ohio, July 25, 2022 – CSafe Global, the innovation leader in temperature-controlled shipping solutions for the transport of life-enhancing pharmaceuticals, announced today that Amy DuRoss has joined the company as President, Cell and Gene Therapies (CGT).

 

In her new role, DuRoss will lead CSafe’s CGT solutions portfolio to support intelligent transport of high-value personalized therapies and vaccines to meet the unprecedented global supply chain transport complexity of CGT products.

 

Ms. DuRoss brings more than 25 years’ experience to her new position. Prior to joining CSafe, she was the co-founder and CEO of Vineti, an enterprise software platform used to digitize chain of identity and chain of custody requirements for CGT products. Earlier in her career, DuRoss held several prestigious positions including, Chief Business Officer at Navigenics, Chief of Staff for the California Institute for Regenerative Medicine (CIRM), and Co-Founder, Co-Author, and Executive Director of California’s $3B stem cell research ballot initiative.

 

“We are delighted to have Amy leading our CGT team. Her diverse experience in both corporate development, patient advocacy and entrepreneurship is exactly the right mix to drive innovation and superior solutions in this deeply complex supply chain,” said CSafe CEO, Patrick Schafer. “We expect to see significant strides forward in this portfolio under Amy’s strategic guidance.”

 

I’m honored to have the opportunity to collaborate with the world-class team at CSafe Global in bringing a new standard of high-quality, high-value supply chain transport to the most exciting innovation area in personalized medicine, cell and gene therapies,” Ms. DuRoss said, “CSafe Global’s outstanding worldwide service network and proven expertise in robust and actionable analytics to drive supply chain efficiencies will hasten the industrialization of an emergent market that offers critical hope for an increasing number of patients in need.”

 

Ms. DuRoss earned her bachelor’s and two master’s degrees, including her MBA, from Stanford University. She serves on the boards of Biolife Solutions (BLFS), MJH, Americans for Cures, and the ARM Foundation and is a member of the Aspen Institute Global Network. 

Softbox by CSafe Global Named Finalist in Fast Company’s 2022 World Changing Ideas Awards

Softbox by CSafe Global Named Finalist in Fast Company’s 2022 World Changing Ideas Awards

Softbox by CSafe Global, the innovation leader in temperature-controlled shipping solutions for the transport of life-enhancing pharmaceuticals, has been named a finalist of Fast Company’s 2022 World Changing Ideas Award in the Company of the Year and Pandemic Response categories for the Ultra-Low Temperature (ULT) shipper designed to ship the first COVID-19 vaccine.

Fast Company’s World Changing Ideas Awards honor clean technology, innovative corporate initiatives, brave new designs for cities and buildings, and other creative works that are supporting the growth of positive social innovation, tackling social inequality, climate change, and public health crises.

As pharmaceutical companies began developing COVID-19 vaccines in 2020, the early results made it clear that the most promising vaccines would require not only deep-frozen transport temperatures, but also extended shipment durations to reach locations around the globe. At a customer’s request, the Softbox team began supporting the design of a highly specialized ULT shipper that could safely transport this critical cargo once it was approved for distribution. The ULT shipper allows the vaccines to maintain the required temperatures between -90°C to -60°C for at least 10 days if unopened. Upon arrival at the final destination, the box can be opened twice a day for up to three minutes each time to allow clinicians to secure vials needed for daily immunizations. By adding dry ice to the box as needed, the Softbox medium ULT shipper can maintain the integrity and viability of the vaccine vials inside for up to 30 days.

Now in its sixth year, the World Changing Ideas Awards showcase 39 winners, 350 finalists, and more than 600 honorable mentions—with climate, social justice, and AI and data among the most popular categories. A panel of eminent Fast Company editors and reporters selected winners and finalists from a pool of more than 2,997 entries across transportation, education, food, politics, technology, health, social justice, and more. In addition, several new categories have been added this year including climate, nature, water, and workplace. The 2022 awards feature entries from across the globe, from Switzerland to Hong Kong to Australia.

Fast Company’s Summer 2022 issue showcases some of the world’s most inventive entrepreneurs and companies tackling global challenges.

“The pandemic put the cold chain industry front and center on the world stage and the Softbox team rose to the challenge, supporting the development of a highly innovative shipper utilizing high performance insulation materials delivered in a robust and reusable construction to ensure the COVID-19 vaccine could be distributed globally and arrive at point of use sites with the vaccine’s quality and efficacy maintained,” shared CSafe Global Chief Technology Officer – Passive Solutions (former Softbox Systems CEO), Kevin Valentine. “I am proud to work with this amazing team of people and look forward to bringing more world changing ideas, products and technology to the market as part of the CSafe Global organization.”

“I am truly honored to be able to share in this recognition and congratulate every single member of the team at Softbox who worked on the design, manufacture and delivery of a truly world changing product,” said CSafe Global CEO, Patrick Schafer.

“We are consistently inspired by the novelty and creativity that people are applying to solve some of our society’s most pressing problems, from shelter to the climate crisis. Fast Company relishes its role in amplifying important, innovative work to address big challenges,” says David Lidsky, interim editor-in-chief of Fast Company. “Our journalists have identified some of the most ingenious initiatives to launch since the start of 2021, which we hope will both have a meaningful impact and lead others to join in being part of the solution.”