See You In Shanghai!

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We will be exhibiting at Phacilitate's Advanced Cell Therapy - Shanghai Summit October 29-31 in Shanghai, China.   Massive interest in our evo system in China and across Southeast Asia, and this gives us a chance to meet some of those folks in person.   

Please contact us if you would like to set up a meeting while we are in Shanghai.

Venue:

KERRY HOTEL PUDONG
SHANGHAI, CHINA

NYT: He Got Schizophrenia. He Got Cancer. And Then He Got Cured.

 Image: Credit - Jesse Jacobs from NYT September 29, 2018

Image: Credit - Jesse Jacobs from NYT September 29, 2018

Watershed moments occasionally come along in medical history when previously intractable or even deadly conditions suddenly become treatable or preventable. They are sometimes accompanied by a shift in how scientists understand the disorders in question. 

We now seem to have reached such a threshold with certain rare autoimmune diseases of the brain. Not long ago, they could be a death sentence or warrant institutionalization. Now, with aggressive treatment directed at the immune system, patients can recover. Does this group encompass a larger chunk of psychiatric disorders? No one knows the answer yet, but it’s an exciting time to watch the question play out.

Just a fascinating article by Moises Velasquez-Manoff in the New York Times September 29, 2018 about an immune system link to mental health problems. We live in exciting times!

Read the article HERE

Euro Privacy: From TechCrunch - France records big jump in privacy complaints since GDPR

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France’s CNIL  agency said today that it’s received 3,767 complaints since May 25, when GDPR came into force, up from 2,294 complaints over the same period last year — which it notes was already a record year.

CNIL says this represents a 64% increase in complaints, which it suggests shows that EU citizens have “seized the GDPR strongly” — attributing public engagement on the issue to media attention on the new regulation and on data protection stories such as the Facebook-Cambridge Analytica data misuse scandal.

It also reports receiving more than 600 data breach notifications, affecting a total of around 15 million people, since GDPR D-Day.

Read the full article at TechCrunch: HERE

Privacy, security, 21 CFR Part 11 compliance are all critical features in the software used in manufacturing of and logistics for cell and gene therapies. We have spent a lot of time and effort making our evo.is the best it can be in all these areas. Contact us to talk about our approach to satisfying these important, new, and complicated issues.

See You in La Jolla!

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We will be attending Cell and Gene - Meeting On The Mesa in La Jolla, CA again this year.   Meeting is October 3-5.  Great opportunity to meet, talk and learn in a wonderful setting.   Please reach out directly or, using the conference app, if you would like to set aside some time.

 

Venue:

Estancia La Jolla Hotel & Spa
9700 North Torrey Pines Road | La Jolla, CA 92037

evo® accepted in to United Cargo's TempControl and LifeGuard system!

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Very excited that United Airlines Cargo has accepted our evo® system into their TempControl and LifeGuard services.  The evo system's unique dynamic performance and lean external packaging system open the evo to shipping on both narrow body and wide body aircraft, thus allowing shippers to take full advantage of United's extensive route system.  We look forward to serving United's cargo customers.

- Dana

United Cargo Announces Acceptance of Savsu Technologies evo Cold Chain 2.0 System  

 

CHICAGO, September 5, 2018– United Cargo today announced it will further enhance both its TempControl and LifeGuard services by accepting the evo®Cold Chain 2.0™ system developed by Savsu Technologies. 

TempControl is United Cargo’s leading service for pharmaceuticals and other health care and life science material requiring temperature-controlled transport, and LifeGuard provides the carrier’s highest-priority same-day service for critically important medical shipments. The evo Cold Chain 2.0 is a fully integrated system designed specifically to provide comprehensive end-to-end transport protection and visibility for live cells used in biotechnology and precision medicine applications.  

“The goal of expanding our customers’ options for packaging and transport systems is to ensure our services remain as relevant and valuable as possible,” said Jan Krems, President United Cargo. “Combining the elevated care and expedited priority of our TempControl and LifeGuard services with the proven thermal stability and dynamic data monitoring and visibilityof the evo Cold Chain 2.0 meets the needs of shippers of the most fragile and precious live material.”

“We are thrilled to participate in United Cargo’s TempControl and LifeGuard programs,” said Bruce McCormick, President Savsu Technologies. “The lean outer packaging of Savsu’s durable, high-performance shipping containers will optimize United’s network for advanced therapy and specialty courier clients by making transport available on both widebody and narrowbody aircraft.” 

United Cargo customers seeking more information on the specifications and availability of the evo Cold Chain 2.0 system should visit https://www.savsu.com.

 

 

About SAVSU

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 www.savsu.com.

 

About United Cargo

United Cargo delivers superior shipping solutions via the cargo capacity of the world’s most comprehensive route network – approximately 4,600 flights a day to 357 airports operated by United Airlines and United Express. United operates a mainline fleet of 757 aircraft, including over 170 wide-bodies, on which United Cargo carried over 3 billion cargo ton miles in 2017. With U.S. mainland hubs in Chicago, Denver, Houston, Los Angeles, New York/Newark, San Francisco and Washington, D.C., and enhanced service to and from Asia and Australia, Europe, Latin America and the Middle East, United Cargo quickly transports customers’ shipments to and from virtually every major cargo market in the world. For more information, please visit unitedcargo.com.

 

 

Media & Investor Relations

Bruce McCormick

President

SAVSU Technologies 

2430 Alamo Avenue SE Albuquerque, NM 87106 

b.mccormick@savsu.com

Savsu Lands New Investment To Fund Accelerating Growth

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Wow, what a busy day!   The first day of Biotech Week - Boston,  great news from United Air Cargo on evo product acceptance into their TempControl and LifeGuard services, and BioLife stepping up to make a big financial investment in Savsu.   We have worked closely with the team at Biolife for years and admire their product, management talent and values.   We appreciate their endorsement of our technology and our team at Savsu.  Most importantly, BioLife's investment allows us to support the accelerating demand for our evo system in cell and gene therapy.

- Dana

Here is the press release issued this morning:

BioLife Solutions Increases Ownership in SAVSU Technologies to 44% with $5 Million Investment

 Agreement Includes 18-Month Option to Acquire all SAVSU Outstanding Shares

BOTHELL, Washington—  September 5, 2018 —BioLife Solutions, Inc. (NASDAQ: BLFS) (“BioLife”), the leading supplier of proprietary biopreservation media products for cell and gene therapies, today announced that it has increased its ownership of SAVSU Technologiesfrom approximately 31% to 44% with a $5 million investment. SAVSU will use the investment to scale up its operations and inventory to support increased demand for its evo®Dry Vapor Shippers and other precision temperature controlled shipping containers for cell and gene therapies.

The 18-month purchase option provides BioLife, at its sole discretion, with the right to acquire the 56% of SAVSU not already owned, for the greater of 1,000,000 shares of BioLife common stock, or approximately $23 million of BioLife common stock, calculated on the day of exercise.  If BioLife exercises the purchase option in the future, 75% of the shares would be issued at closing, with the remaining 25% issued upon the achievement of specific revenue milestones.

Mike Rice, BioLife CEO, commented, “This additional investment in SAVSU supports our previously announced growth strategy to invest in companies and technologies that also supply the cell and gene therapy industry with innovative, highly valued solutions.  We believe SAVSU is at an inflection point in product adoption in the cell and gene therapy market. The purchase option provides BioLife with complete flexibility with regard to a full acquisition of SAVSU, while setting a value today.  Our decision to exercise the purchase option will be based on SAVSU’s continued revenue growth, and determining the optimal time to consolidate SAVSU and BioLife’s financial results.”

“We welcome this additional investment by BioLife as we grow our business,” stated Dana Barnard, SAVSU Technologies CEO. “SAVSU shippers and our evo cloud-based information system are currently being used by or in final evaluation with over 30 leading cell therapy companies. Along with these direct customers we are working closely with the world’s leading specialty logistics companies to provide seamless global distribution of the SAVSU shippers with real time information systems. SAVSU shippers can be used for both apheresis collections and manufactured cell therapies. Providing both inbound and outbound shipments on a single information platform, integrated with logistics partners and manufacturing sites, is our unique added value in the currently fragmented cold chain logistics paradigm.”

About BioLife Solutions

 BioLife Solutions is the leading developer, manufacturer and supplier of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media for cells and tissues. Our proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the regenerative medicine, biobanking and drug discovery markets. Our biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death; offering commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function.

For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.

About SAVSU Technologies

SAVSU is a privately held 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 www.savsu.com.

 Cautions Regarding Forward Looking Statements

Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements concerning the company's anticipated future growth strategy, including the acquisition of synergistic cell and gene therapy manufacturing tools and services or technologies, the potential utility of and market for its products and services and potential revenue growth and market expansion. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

 

 

 # # # #

 

 

  

 

Media & Investor Relations

 

Roderick de Greef

Chief Financial Officer

(425) 686-6002

rdegreef@biolifesolutions.com

 

 

 

 

See You In London!

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Heading straight to London for Phacilitate: Leaders Europe 2018 following Boston Biotech Week conferences.  Conference is September 11-12.  

Bruce McCormick, President of Savsu, will be speaking on September 11 as part of the program on commercialization .

Please note that for this conference we will have a meeting room rather than a booth in the exhibit hall.  Our room is:  Willow 3  (1 level above the exhibition hall). We will have samples of our evo DV series units on display in the room.

Conference info: (click to go to site)

11-12 SEPTEMBER 2018
ROYAL LANCASTER LONDON, W2 2TY

FDA Issues New CMC Guidance For Cell & Gene Therapy. Savsu Can Help

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July 20, 2018, the FDA published this document:

Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)…Draft Guidance for Industry

The FDA Guidance Document Can be found HERE

We finally finished reading the whole thing and wanted to bring your attention to Module 2 (Summary of Quality Information), Section D (Product Handling At The Clinical Site).   Please read the following excerpt from that document and, if you are uncertain how to comply, then call us (or stop by to see us at the upcoming shows in Boston and London).  

Module 2. Summary of Quality Information
Section D. Product Handling at the Clinical Site

Proper control of the finished DP is critical to your investigational studies. Therefore, your IND should also include a description of how the product will be shipped to, received, and handled at the clinical site to ensure safety, product quality, and stability.  Your IND should also include information on shipping conditions, storage conditions, expiration date/time (if applicable), and chain of custody from the manufacturer to the site of administration in the summary information of the CTD. Your summary in Module 2 should also include information for product handling at the clinical site prior to administration (such as thawing, washing, or the addition of diluent or adjuvant, loading into a delivery device, and transport to the bedside) and summary information on product stability prior to and during administration (e.g., in-device hold times and temperatures).
— FDA: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)…Draft Guidance for Industry

Our evo system (evo hardware + evo.is) currently supports the guidance advise relating to shipping condtions, storage conditions expiration date/time, chain of custody,  and handling at the clinical site to the bedside. 

We are proud to have lead the way in the awareness of these needs and to have developed a solution for these needs. Our system is IND ready!

Kymriah® Approved By EC & Novartis Announces New Facility

 FILE PHOTO: Swiss drugmaker Novartis' logo is seen at the company's plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo

FILE PHOTO: Swiss drugmaker Novartis' logo is seen at the company's plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo

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 Novartis today announced that the European Commission (EC) has approved Kymriah® (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Kymriah   developed in collaboration with the University of Pennsylvania (Penn)   is a ground-breaking one-time treatment that uses a patient's own T cells to fight cancer, and the only chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in the EU for these two distinct B-cell malignancies. Kymriah was also the first CAR-T cell therapy ever approved by the US Food and Drug Administration (FDA)....

...

With the approval in Europe of its CAR-T cancer drug Kymriah, Novartis figures demand will call for more production. To crank that capacity up, the drugmaker will build a plant in Switzerland that eventually may employ 450 workers.

 

Fierce Pharma article HERE 

Reuters article HERE 

Press Release HERE

 

 

 

Yescarta® Approved By EC

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Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Commission (EC) has granted Marketing Authorization for Yescarta® (axicabtagene ciloleucel) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. The Marketing Authorization approves axicabtagene ciloleucel for use in the 28 countries of the European Union, Norway, Iceland and Liechtenstein.

 

Read Press Release HERE

See You In Boston!

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We will be at two, yes two, conferences in Boston, September 4-7 as part of Boston Biotech Week.

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We will be at Booth: #22

Venue:

Seaport Hotel & World Trade Center
One Seaport Lane, Boston
MA 02210

Conference Info: Here

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We will be at Booth: #2064

Venue:

Hynes Convention Center,
Boston, MA

Conference Info: Here

Bruce McCormick, President of Savsu, will be speaking at this event on Friday September 7, 9:00-9:30AM in the "Logistics, Supply Chain, and Cryopreservation" track.

Topic of talk is "Experience From The Field: Maintaining a Two Temperature Cold Chain For Regenerative Medicine".   Link to program is HERE

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We have a new home! But...you can't visit yet.

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We have secured a fantastic new location for Savsu's Design and Technology Center in Albuquerque! 

New Address:   4209 Balloon Park Rd. NE, Albuquerque, NM 87109

The 10,000 sf building will house an expanded design and prototyping facility with new robotic and CNC machinery, our growing customer service group, an expanded warehouse and fulfillment group, high speed data center, and new training facility.  Our new Albuquerque home is the latest in our growing, distributed network of business centers: software dev (Seattle, Washington), component assembly (Leon, Mexico), and business services (Old Bethpage, NY).

We can't wait for you to visit but....we're not quite ready yet!   The building is being completely remodeled for us right now.   We will begin moving machinery and equipment in late August.  Target move-in completion is mid September. 

We are so excited about our new place we issued a press release to let everyone know: read it HERE

We look forward to showing you around our new home!

(Oh!  Just got a nice article about our expansion in the Albuquerque Business Journal:  you can read it HERE)

 

SAVSU Technologies Awarded New Patent for Cold Chain Technologies Used in Cell and Gene Therapies

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Following is the latest announcement released on PR Newswire this morning. We are excited to announce that we were awarded another patent by the USPTO, this time for our "stability timer" feature in our evo.is app.   This customizable feature lets all parties focus on the time critical nature of a shipment.

Savsu continues to innovate on both the hardware and software sides of the business.  It's an imperfect analogy but, our evo system is a bit like the manned space program: our hardware is the"space capsule" and our  evo.is software is "mission control".   You needs both working in harmony to bring the precious cargo safely home.  Look for more announcements about hardware and software innovations in the coming months.

-Dana

6 Additional Pending Patent Applications Submitted for evo Smart Shippers, Liquid Nitrogen Dry Vapor Shippers and Cold Chain SaaS Application

ALBUQUERQUE, N.M., July 31, 2018 /PRNewswire/ -- SAVSU Technologies, the leading developer of smart, precision biologic shipping containers and cloud-based cold chain management SaaS solutions, today announced that the USPTO has issued a notice of allowance of patent number 10,018,614 B2, titled "Biologic Stability, Delivery Logistics and Administration of Time and/or Temperature Sensitive Biologic Based Materials". The inventors are Bruce McCormick, President of SAVSU Technologies, and Mike Rice, CEO of BioLife Solutions (NASDAQ:BLFS). 

SAVSU has been granted 3 patents and has 6 other pending patent applications related to novel innovations incorporated into current, or to be incorporated into future, precision thermal shipping containers under the evo brand, including models that precisely maintain biologic payload temperature stability across the entire shipping continuum including -196°C using liquid nitrogen dry vapor shippers, -80°C using dry ice, and 2° - 8°C and controlled room temperature (CRT) using conditioned phase change insulating materials. These patent applications also include claims related to the evo.is Cold Chain Software as a Service (SaaS) live cell visibility platform. 

Bruce McCormick, commented, "This patent grant further validates our mission to offer truly innovative biopreservation tools for regenerative medicine, with a focused and intentional goal to improve cold chain logistics of cell and gene therapies.  We believe the advanced and innovative evo hardware and software technologies will have tremendous impact on the preservation, delivery, and quality management of these precious, time and temperature sensitive biologic medicines."

An Analysis Of 2017 FDA Warning Letters On Data Integrity by Barbara Unger

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Interesting article about the focus on "Data Integrity" by the FDA by Barbar Unger, Unger Consulting, in BioProcess Online.  Read the full article HERE.

 

Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions.

The FDA initiated enforcement actions in this area as early as 1999 and continued to the point where the last three years have seen data integrity cited in 68 to 80 percent of warning letters. We have seen ever-increasing participation by global health authorities.

Executive Management Ownership

  • Executive management must understand that health authority focus on this area is not going to diminish. Data governance applies to both paper and electronic data throughout its life cycle.
  • Executive management must establish and maintain a corporate culture of openness where employees may report problems and failures without fear of retribution. In fact, reporting of problems should be encouraged and rewarded.
  • Executive management must own the gap assessment process and remediation efforts. Remediation may be costly and time-consuming. Firms often uncover additional problems along the way. Don’t expect to complete remediation quickly; it’s often a multiyear process.

 

Savsu and Doctors Without Borders in the Ebola fight

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While Savsu's main business focus is providing thermo informatic systems for the regenerative medicine marketplace, our roots are in creating products for the public health market and we still are actively engaged with non-profits and NGO's working on the front line against terrible diseases like ebola and monkey pox.   Savsu's complete line of  "quiet" evo devices are designed to be rugged, simple-to-use, effective protectors of vital medicines and vaccines that work in difficult conditions.   The CryoQ in particular has played a vital role in combating recent ebola outbreaks and is being used by the World Health Organization and Doctors Without Borders.

While we are very happy to contribute to this global battle, the real heroes are the volunteers who are working on the front line in difficult and confusing situations.   In this post we want to highlight the effort of Doctors Without Borders (Medecines Sans Frontieres) who are seemingly everywhere there is a need for critical medical help.

The first link is to a post on their website updating readers on the latest reemergence of the ebola virus in the Democratic Republic of Congo.  

"Unlike in previous Ebola outbreaks in DRC, where cases have been concentrated in remote villages, patients have now been diagnosed in Mbandaka, a Congo river port city of more than one million inhabitants. While easy access to transportation routes increases the risk of the virus spreading, surveillance is being reinforced."

The second link is an NPR interview with Leah Feldman, a nurse form Maryland and a volunteer with Doctors Without Borders, giving a glimpse of what it is actually like to be in theses remote areas fighting an outbreak.

"Well, you try to breathe because it's very hot. And make sure you don't have fog on your glasses. The taking of the sample is exactly the same as for any nurse who does a blood sample anywhere — but be very, very careful with the needle. Make sure you have all your materials with you before start, then just take a normal blood sample."     Leah Feldman via NPR

Savsu's Public health page opens with the statement "We believe global health starts with local health."  Our quiet evo products are designed to deliver and protect life saving medicines in challenging environments to protect "local health" wherever that maybe.   However, organizations like Doctors without Borders, WHO and volunteers like Leah Feldman are the ones who put themselves at risk to make it work on behalf of all of us.   

You can donate to support Doctors Without Borders HERE .

Xconomy: With Roche Data, Cancer Combos Post First Win Vs. Small Cell Lung Cancer

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"Cancer immunotherapy combinations continue to chalk up wins against lung cancer. For the first time, an immunotherapy-chemotherapy combination has succeeded in a late-stage study of patients with small cell lung cancer (SCLC), a particularly aggressive form of the disease often linked to smoking."

--Xconomy, June 25, 2018

Interesting article about combinations therapies successfully fighting small cell lung cancer for the first time.   Therapies combining immunotherapies and chemotherapies are already being used to treat non-small cell lung cancers.  Read the full post HERE