SAVSU in the news: "Pharma’s cold chain is going below zero"

Cellular and genetic therapies drive a ‘new paradigm’ for logistics

Very good article highlighting the challenges of moving the new cell therapies and industry's response.   Savsu, Bruce McCormick, and our DV-10 featured in the article along with folks from BioLife, TrakCel, Fisher BioServices, and Cryoport.    Thanks to Pharmaceutical Commerce for presenting such a good article and including us.

"While all of this is generating high enthusiasm in R&D circles, logistics service providers are scrambling to revise their processes to meet the new demands of these therapies. A “new paradigm” is evolving, in the words of Bruce McCormick, President of Savsu..."


Way To Go! First Approved Cell and Gene Therapy for Osteoarthritis

The use of pre formulated hypothermic storage and cryogenic freeze media is becoming the cell therapy standard practice. BioLife Solutions is the scientific leader in this field. The ability to store and freeze cells to achieve maximum post thaw viability is a critical process leading to successful cell therapy commercialization. This news represents one more important step forward in bringing the advances of cell therapies into practical commercial application. Congratulations to our friends at Biolife Solutions!

FDA Briefing Document: Novartis/Tisagenlecleucel

We are NOT Doctors but, we read this very important briefing document from the FDA because our evo Cold Chain 2.0 system will be part of the manufacturing process for Car-T cells.   Very interesting that the FDA highlighted the challenges in manufacturing this new therapy.   Specifically, they mentioned the challenge of controlling process variability: "It is also critical to understand and address sources of variability seen in the individual products. This can be a challenging issue given the complex and labor-intensive manufacturing processes involved with making a CAR T cell product"

Control of process variability is one of the most important outcomes of adopting the evo Cold Chain 2.0 system.  The superior thermal performance and data reporting of our 2-8C evo's (designed specifically for the inbound leg), and our new DV -196C cryo shippers dramatically reduces process variability.

4.1.1 Control of tisagenlecleucel quality through manufacturing process controls

A major consideration for manufacturing tisagenlecleucel is the establishment of a well- controlled manufacturing process that can consistently produce high-quality CAR T cells that are safe, pure, and potent. Consistency in product quality is necessary to provide reasonable confidence that each lot (batch) of tisagenlecleucel will perform as expected at a given dose in patients.

In order to control the manufacturing process for consistency, it is necessary to thoroughly understand the manufacturing process and critical product quality attributes unique to the autologous CAR T cell products. It is also critical to understand and address sources of variability seen in the individual products. This can be a challenging issue given the complex and labor-intensive manufacturing processes involved with making a CAR T cell product (Figure 1). These challenges can include variability in the starting materials (e.g., patient’s own leukapheresis cells) and human or animal derived reagents (e.g., serum, antibodies); and control of critical components that may be manufactured under contract (e.g., transfer vectors that encode CAR, final container).

Novartis Briefing Document: Click Here

FDA Briefing Document: Click Here

Brooks Automation: Study Comparing Two Methods of Preparing, Transporting, and Storing Live T-Cells

A recent poster authored by Brooks Life Science Systems and BioLife Solutions compared two methods of preparing, transporting and storing live T-cells at both -80°C and -190°C to demonstrate best practices to achieve the highest post-thaw viability.

The quality of procedures and products used for preparing, transporting and storage of cells at both -80°C and -190°C temperatures have a direct impact on post-thaw viability and functionality. Sub-standard preparation, handling, storage, and products may subject cells to improper cryoprotectant exposure, poorly controlled shipping and storage conditions and temperatures.

Savsu participated in this study with Brooks and BioLife.  Great work.

You can download this poster instantly here:


Unanimous Advice To FDA: Approve Landmark CAR-T Cancer Therapy

“It’s the most exciting thing I’ve seen in my lifetime,” said Timothy Cripe, a blood cancer and bone marrow transplant specialist at Nationwide Children’s Hospital in Columbus, OH.

...The therapy would involve genetically modifying a patient’s T cells to kill cancer and then infusing them back into the body. The dramatic effect of the treatment, known for years as CTL-019, was never questioned at the meeting. Of 68 young people receiving it, 52 of them had an excellent response almost immediately, with their cancer disappearing within the first three months. Three-quarters of those patients remained cancer-free six months after treatment.

This is a really big deal for the industry.

  Read the full article here

Savsu and the DV Series Comes to Bio International - San Diego!

Along with a ton of new, fabulous microbreweries, Meow Wolf, great skiing and mountain biking, New Mexico also has an emerging biotech scene and we are part of it!  Will will be exhibiting with NMBIO and a host of other NM ventures at BIO International in San Diego June 19-22.   Come visit us at Booth 4529 in the New Mexico pavilion.

Savsu will be introducing our new DV series of dry vapor shippers for the first time in the United States.   The DV series, powered by our new Fusion System is absolutely rewriting cryo shipper performance, which means biotech companies can rethink what is possible in logistics.   The DV Series is part of a system that we developed specifically for for moving live cell therapies called evo® Cold Chain 2.0

By the way, here is an interesting article on NMBIO from February of this year.

See you there!

Hello From ISCT - London!


Having a terrific time at ISCT 2017 - London.   We are here through Saturday, May 6 and are sharing booth space with our partner, BioLife Solutions.   Come visit us at Booth 410!

Response to the announcement of our new dry vapor shippers, and the evo® 2-8 XL has been overwhelming.  Thanks to all who have stopped by the booth so far to discuss working with us.  This conference has such intelligent, imaginative people doing such interesting to talk to!

DV-4 is a smart dry vapor shipper designed for domestic shipments of 4-5 days duration (example: within US and Europe).   DV-4 is about half the size of full sized dry vapor shippers, still has a wide neck to accommodate full size cassettes, charges in 20 mins, uses the same evo Vision cloud based platform as all other evo products, and cleans easily.  

DV-10 is our long range dry vapor shipper, offering 10-15 days autonomy, and, like the DV-4,  features our new Fusion technology which speeds charging, dramatically improves dynamic performance, and improves protection of precious  payloads.

evo 2-8C XL is designed primarily for larger volume, fresh cell, inbound shipments.   Simple pack out , very long autonomy, and the evo Vision platform combine to give leading biotech companies and specialty couriers unprecedented information and control over their process.  The evo Cold Chain 2.0 system significantly lowers risk in one of the riskiest sections of the suppy chain. 

See you at the booth,


SAVSU Technologies Announces New evo® DV™ line of Dry Vapor Smart Shippers with New Fusion™ Technology

SAVSU Technologies Announces New evo® DV™ line of Dry Vapor Smart Shippers with New Fusion™ Technology for Rapid Charging and Superior Dynamic Performance


-196°C Liquid Nitrogen Shippers Expand Existing Cold Chain 2.0™ System


ALBUQUERQUE, NM — May 4, 2017 -- SAVSU Technologies, the leading developer of smart, precision shipping containers and cloud-based cold chain management SaaS solutions, today announced that it is extending its product line with the addition of two new evo dry vapor liquid nitrogen shippers for frozen transport of biologic materials at -196°C. The products are making their debut at The International Society for Cellular Therapy Annual Meeting, May 3-6 in London. Both new models share the brand-new evo Fusion System™ which combines the Fusion Smart Cap™ and Fusion Quick Core™ for extended dynamic performance and dramatically faster charge times. The two new models are the evo DV-4 with four-day autonomy for domestic shipments and the DV-10 with 10-day autonomy for international shipments. The DV-4 is approximately half the weight of standard, full size, large neck, dry vapor shippers.


In addition to rapid charging, the new evo Fusion system is safer and easier to load and unload, provides a safer method of storing the biologic materials such as a manufactured cellular therapy, and, in the case of the DV-4, offers improved ergonomics for cell therapy manufacturers and clinicians.


Both evo DV models are smart and communicate with evo Vision™, SAVSU’s IoT award-winning,  cloud-based data and communications SaaS. With the addition of the -196°C product line, SAVSU is now the only company offering products to support the entire temperature range (CRT, 2° - 8°C, -80°C and -196°C) for source materials and manufactured cell therapies; all sharing a common data system, specifically designed for live cell therapy companies.


evo Cold Chain 2.0 is a disruptive live cell visibility platform consisting of the evo Smart Shipper family and evo Vision cloud-based, live cell visibility platform for temperature sensitive biologic materials and drug products.


“Despite numerous requests from our customers to develop an evo shipper in the -196°C range, we said we wouldn’t do it unless we could dramatically advance the existing dry vapor shipper technology. We don’t do ‘me too’ products,” said Bruce McCormick, President of SAVSU. “Well, now we have done it!  With the development of the new evo Fusion technology powering our new evo DV line, we have significantly advanced dry vapor shipper technology, which hasn’t changed much in 40 years. We believe these are important new products to support the commercialization of new personalized cell therapies.”


Both new evo DV models will be available for order on May 3, 2017.   Visit SAVSU at the BioLife/SAVSUbooth at ISCT in London.   For more information, please visit



About SAVSU Technologies


SAVSU is a leading designer and manufacturer of innovative high performance cloud-connected passive storage and transport containers for temperature sensitive biologics and pharmaceuticals. Our mission is to improve global health by greatly reducing the waste and risks associated with the improper freezing and overheating of thermal-sensitive medicines and biologics. SAVSU has developed proprietary state-of-the-art technology to ultimately lower costs and improve delivery of these most essential materials. For more information please visit


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SAVSU and TrakCel announce collaboration to integrate Cell Therapy Manufacturing and Cold- Chain data management platforms

Integrating Cell Orchestration and Live Cell Visibility Platforms Will Provide Enhanced, Auditable Vein-to-Vein Documentation Supporting Clinical Trials, Commercial Distribution and Reimbursement of Cell-Based Therapies  


ALBUQUERQUE, NM and CARDIFF, UK — April 25, 2017 -- SAVSU Technologies, the leading developer of smart precision shipping containers and cloud-based cold chain management SaaS solutions, today announced that that it will collaborate with Cardiff-based TrakCel Ltd to integrate  its evo® Cold Chain 2.0™system with TrakCel’s Cellular Orchestration Platform™.

evo Cold Chain 2.0 is a disruptive live cell visibility platform for management of time and temperature sensitive biologic materials powered by the evo cloud-connected Smart Shipper and evo Cold Chain Management SaaS. This cloud-based, cold chain management platform integrates shipping container pack-out, freight carrier selection and purchase, and real-time GPS location and payload temperature monitoring, with critical alerts provided to stakeholders in the clinical delivery chain, including shipment, approaching destination, delivered, opened and remaining shelf life.

TrakCel’s Cellular Orchestration platform facilitates efficiency and compliance to quality standards in cell therapy manufacturing by enabling program-critical information to be collated, tracked and and documented. Detailed processes and managed workflows for every participant in the value chain enable safe and efficient scaling outward and upward as production increases. Conditional logic workflows for all participants including clinicians, logistics and manufacturing partners ensure standardization and compliance with validated procedures.

Bruce McCormick, President of SAVSU Technologies, remarked, “Our optimized technologies represent the next generation of integrated, cloud-connected cold chain technologies. We are very pleased to collaborate with TrakCel and look forward to integrating our respective data platforms to provide even more value to our mutual customers. We are committed to driving a paradigm shift away from traditional, risk-laden cold chain practices based on the use of poor performing shipping containers and disconnected data systems.” 

Ravi Nalliah, CEO at TrakCel, commented, “We scoped the packaging and cold chain technologies space to identify best of breed ecosystem partners. SAVSU is so far ahead of traditional container and data logger suppliers, and we are very keen to integrate their innovations into our Cell Orchestration Platform. The timing of this collaboration is perfect as the cell therapy market continues to mature and awareness is peaked on the need to use better tools to enable clinical trial success, commercial scale-out, and reimbursement supported by evidence of compliance throughout manufacturing, distribution and patient administration.”

 Chain Link Research and Pharmaceutical Commerce market research estimate that there are 80 million to 130 million annual temperature sensitive pharmaceutical shipments requiring cold chain management, resulting in $12 billion spent annually on cold chain logistics, with $9 billion for transportation and $3 billion for specialized tertiary packaging and instrumentation such as insulated boxes, blankets, phase change materials, temperature sensors and dataloggers. The use of currently available cold technologies results in $15 billion to $35 billion spent annually replacing products lost due to temperature excursions.


About SAVSU Technologies

SAVSU is a leading designer and manufacturer of innovative, high performance, cloud-connected passive storage and transport containers for temperature-sensitive biologics and pharmaceuticals. Our mission is to improve global health by greatly reducing the waste and risks associated with the improper freezing and overheating of thermal-sensitive medicines and biologics. SAVSU has developed proprietary state-of-the-art technology to ultimately lower costs and improve delivery of these most essential materials. 

For more information please visit


About TrakCel

TrakCel's cell, gene and immunotherapy management solution improves clinical study efficacy and accelerates global scale-up and scale-out by implementing communications technology to integrate the delivery path from needle-to-needle. The technology provides interactive instructions to

professionals across the supply chain and gives stakeholders on-demand visibility of procedural results and chain-of-custody data for immediate traceability, validation and compliance audits. 

TrakCel technology is increasingly being adopted by leaders in the cell, gene and immunotherapy industry. TrakCel is headquartered in Cardiff, Wales with a U.S. offices in Newport Beach, Californiaand Bridgewater, NJ. 


For more information please visit


SAVSU Media & Investor Relations                                      

Dana Barnard                                                                                       

Chief Executive Officer                                                        

SAVSU Technologies, Inc.                                                                   




TrakCel Media & Investor Relations

Hannah James

Marketing manager

TrakCel Ltd.

Stem cells offer hope for autism

Stem cells offer hope for autism


Fascinating article/news piece on CNN.  Very early study using stem cells to treat autism.

"Cautious Optimism.....Kurtzberg has a hypothesis about what may be happening: that certain immune cells within the cord blood are crossing the blood-brain barrier and altering brain connectivity while also suppressing inflammation, which may exist with autism."

Read article here

Interview with Sam Herbert - World Courier

Very good interview with Sam Herbert, President - World Courier, in American Pharmaceutical Review.   Sam describes the unprecedented complexity that cell and gene therapy companies are facing as they begin to commercialize their therapies.


 "Because the patient’s own body is part of the product—and therefore part of the manufacturing and supply chain processes—cell and gene therapy manufacturers face complexities that are orders of magnitude greater than many other specialty and orphan products."
Sam Herbert   President - World Courier

Read more here:


Fisher BioServices - Packaging Qualification Webinar

Fisher BioServices - Packaging Qualification Webinar

"The experts at Fisher BioServices have an extremely informative presentation on Process Validation and Packaging Qualification. They also cover the critical considerations of dynamic testing, packaging orientation, and payload specifically qualification.

This is essential information for the handling of bio materials used in Cell and Gene Therapies. This presentation highlights many of the dynamic process issues that we take into account when designing our EVO® products."

Bruce McCormick, President - Savsu Technologies

Find video blog of webinar here.


"This is the future of medicine. There is no turning back"

Albuquerque: SAVSU's Kevin O'Donnell presenting at Global Clinical Supply Group's 2017 Annual Conference

SAVSU will be co-presenting Supply Chain Requirements for Cell & Gene Therapy workshop at the Global Clinical Supply Group Spring Conference at the Hyatt Regency Tamaya Resort & Spa in Albuquerque, NM, on April 24th and 25th, 2017.  

This marks the 30th year for the Annual Conference. The workshop will be delivered over two days by Kevin O’Donnell, VP Cold Chain Standards, Practices & Compliance at SAVSU Technologies, and Krisztina Poda, Director of Business Operations Cell/Gene Therapy, at Pfizer Inc., Global Clinical Supply.

This will be the first year GCSG has had a workshop specifically targeting Cell & Gene Therapy clinical trials.

Workshop Title:  Supply Chain Requirements for Cell & Gene Therapy


The distribution and handling of precious gene therapy supplies requires a higher level of controls to ensure quality and sustainability.

Learning Objectives:

Attendees will be able to:

(1) Compare and contrast the logistics requirements of standard cold chain products versus cell and gene therapy products

(2) List at least two (2) concerns in the handling of cell and gene therapy clinical materials

(3) Describe the appropriate classification and labeling of cell and gene therapy products to ensure compliant transportation

"Can CAR-T Be Tamed?"

"Administering CAR-T therapy isn’t like dispensing pills or infusing chemotherapy. Treating patients with CAR-T “requires an immense amount of planning and coordination and meetings,” says Fathi of Massachusetts General Hospital. He ticks off a long list of personnel who have to be in the loop, including cell processing experts, nurses, clinical trial coordinators, lab researchers, pharmacists, and physicians who specialize in infectious disease, pulmonary and critical care, and neurology.  "   

From the article "Possible Cures. Mystery Deaths. Daunting Costs. Can CAR-T Be Tamed?"


These advanced live cell therapies demand a new, "many-to-many" communication system because "a long list of personnel have to be in the loop".   As these therapies get closer to commercialization many parties are recognizing the need for a new approach as existing systems cannot offer a solution.  Cold chain 1.0 is a "1-1" communication system (shipping clerk to shipping clerk), where data are received post-transport and generally relying on manual notification to stakeholders after-the-fact.  The evo® Cold Chain 2.0™ communication system is uniquely designed specifically for the challenges of moving live cell therapies - across campus, across country, or across the globe.   It simplifies the task of keeping many parties in the loop by transmitting real-time (or near real-time) data to assignable key personnel, providing timely, relevant, and actionable information.

Go Boldly!

"Dylan Thomas penned "Do not go gentle into that good night" in 1947, but the sentiment is as timely today as it ever was. Millions of Americans are battling serious illnesses, but they’re not alone in the fight. They have the support of thousands of biopharmaceutical researchers whose lives are dedicated to helping patients go boldly into longer, healthier, and more productive lives."      
--America's Biopharmaceutical Companies (

These videos are inspiring.  The more we work with the people in the biopharmaceutical industry the more excited we are about where medicine is going, and the part we are playing in that future.   The story of these researchers and the technology that they have created needs to be told.  Boldly!  (

(Note: Dylan Thomas' poem below the video)

Do not go gentle into that good night


Do not go gentle into that good night,
Old age should burn and rave at close of day;
Rage, rage against the dying of the light.
Though wise men at their end know dark is right,
Because their words had forked no lightning they
Do not go gentle into that good night.
Good men, the last wave by, crying how bright
Their frail deeds might have danced in a green bay,
Rage, rage against the dying of the light.
Wild men who caught and sang the sun in flight,
And learn, too late, they grieved it on its way,
Do not go gentle into that good night.
Grave men, near death, who see with blinding sight
Blind eyes could blaze like meteors and be gay,
Rage, rage against the dying of the light.
And you, my father, there on the sad height,
Curse, bless, me now with your fierce tears, I pray.
Do not go gentle into that good night.
Rage, rage against the dying of the light.
Dylan Thomas, 1914 - 1953
From The Poems of Dylan Thomas, published by New Directions. Copyright © 1952, 1953 Dylan Thomas. Copyright © 1937, 1945, 1955, 1962, 1966, 1967 the Trustees for the Copyrights of Dylan Thomas. Copyright © 1938, 1939, 1943, 1946, 1971 New Directions Publishing Corp.. Used with permission