Sometimes in the process of getting it there, when air cargo delivery must meet the need, factoring in all the variables including new possibilities can be illuminating, enlightening, and ultimately even helpful.
     Here we look briefly into the expanded usage of a process called lyophilization.
     Lyophilization, also known as freeze drying, is a dehydration process that takes place after a product has been frozen. Lyophilization is gaining popularity in the life sciences for reagents and assays due to its numerous benefits, including extended shelf-life and ease-of-use.
     The world now awaits a COVID-19 vaccine, reportedly a two-shot sequence, with delivery to 8 billion people along with other therapeutics, that would see that dreaded one-way trip to the hospital turn into a roundtrip back to life.

The Need For Speed

     How to get the help to every part of the world quickly is viewed in some quarters as an overwhelming challenge.
     In parts of the world where people cannot easily be reached or are placed on a lower priority on the vaccine chain, thinking about how to deliver a widespread cure bears a bit of thought.
     When it comes to relief from COVID-19, time is not on our side.
     Forget about thinking outside of the box. In a global emergency how about thinking with no boxes at all?

It Takes Good Timing

     It may be too early for wide-based delivery of the COVID-19 serum and therapeutics in a freeze-dried form, but by accelerating technologies already in place, pharmaceuticals via freeze drying could reach people in places where cold-chain pharma simply cannot.
     No doubt freeze drying process has important applications in the pharmaceutical and biotechnology industries in the forseeable future.

Emerging Technologies

     Currently pharmaceutical freeze drying doesn’t get the big headlines, but the process driven by the global need for serums and plasmas could be at the edge of wide acceptance.
     In some sectors, freeze drying is standard process used to stabilize, store or increase the shelf life of drug products and other biologicals.

The Process

     Freeze drying pharmaceuticals uses the aforementioned process called lyophilization to lower the temperature of the product to below freezing, and then a high-pressure vacuum is applied to extract the water in the form of vapor.
     The vapor collects on a condenser, turns back to ice and is removed.
     Finally, a gradual temperature rise extracts all remaining 'bound' moisture from the product.
     This process retains the physical structure and preserves the material for storage or transport.

Kibblewhite Reports From New Zealand

     “With freeze drying, delicate, unstable or heat-sensitive drugs and biologicals can be dried at low temperatures without damaging their physical structure.
     “Freeze-dried products can be reconstituted quickly and easily, which is particularly valuable in the case of the COVID-19 emergency vaccines and antibodies,” says Blair Kibblewhite, Sales & Marketing Manager of Cuddon Freeze Dry located in South Island, New Zealand.
     Cuddon is a manufacturer of freeze-dry machines that are sold worldwide.
     Although Cuddon builds equipment that in some applications might accelerate freeze-dried pharma, Kibblewhite admits the process while possible, based on demand is not foremost in the company plan.
     But in this brave new world of 2020 Cuddon, to their credit, like many others in the rest of the world, seems open for new ideas.
     “We have been manufacturing commercial and industry freeze dryers for over 55 years," Blair said, “however in that time we have only built a couple of small freeze dryers that were suited to the pharma market.
     “Although some clients have used our commercial built dryers for pharmaceutical products, their specification was not at the level of a pharmaceutical freeze dryer.”
     After Blair said those words, visions of people in seats with igloo coolers filled with ice-packs and serum kept popping up.
     “With the latest sales of our freeze dryers, none are being used directly for COVID-19.
     “However, there is recent word that Lactoferrin, a dairy industry-based therapeutic could be used in some way to thwart COVID-19.
     “Lactoferrin is an extract of whey.
     “Whey protein is (routinely) dried in Cuddon Freeze Dryers,” Blair Kibblewhite said.

Generational Freeze For 100 Years

     In Kingston, New York about 90 minutes north of New York City, Millrock Technology Pharmaceutical Freeze Drying says it “is always looking to provide new innovations to the pharmaceutical freeze drying industry.”
     T. N. Thompson, (TNT), President, Millrock Technology said, “As an innovator, we listen to the needs of the market, while providing value in our product line.
     “We offer cutting-edge technologies and optimized methods of pharmaceutical freeze drying. Millrock Technology, Inc. manufactures robust and dependable freeze dryers, customized for the pharmaceutical/biotech marketplace.”
     Millrock with over 100 years combined experience designing, manufacturing and supporting freeze-drying equipment, is the only “3rd generation” (grandfather, father, son) freeze dryer company in the world.
     The Thompson family also founded two other very successful freeze dryer manufacturing companies.

Millrock Purdue NSF Partnership

     Recently Millrock Technology partnered with Purdue University on a U.S. National Science Foundation-funded project to develop “Self-Driving” pharmaceutical freeze dryers.
     “Pharmaceutical freeze drying has a reputation of being an expensive and time-consuming process, but the latest freeze drying innovations are saving money and time, as well as changing the face of freeze drying forever,” TNT said.
     “We are committed to developing these innovations, and pleased to be part of a new partnership with researchers at Purdue University who are working toward more cost-efficient manufacturing through automated lyophilization,” Purdue School of Aeronautics and Astronautics said after receiving an NSF grant of $750,000 to develop real-time sensor technologies, computational modeling, and bioanalytical tools for closed-loop lyophilization.
     Millrock is providing the freeze drying technology that researchers are using for the NSF project at LyoHub in Purdue’s Discovery Park.
     “Millrock Technology is excited to work with Purdue on this project,” TNT said.
     “The sensors and concepts proposed by Purdue in combination with the techniques and technologies developed by Millrock throughout the years is promising to produce major improvements in the freeze drying process.”

Cut Production Time By 50%

     One major hangup is that current freeze drying methods lack real time control or measurements, and inputs are fixed at a constant value.
     A typical production lyophilization cycle can take up to two weeks, because without in-process product monitoring and closed-loop control, the cycles are overly conservative and lengthy.
     With sensors delivering real-time measurements, the use of heat transfer models, and the ability to constantly change the conditions inside the freeze dryer, the cycle can be optimized.
     The result:  significant time and cost savings. Purdue’s project aims to create and implement a closed-loop “autopilot” system in which product state measurements are taken during drying and fed back into a controller.
     Purdue’s team believes this type of system could cut the freeze drying cycle time by as much as 50 percent.
     More from Purdue University School of Aeronautics and Astronautics here.

When Speed Is The Need

     The idea or dream of a portable yet stable serum for COVID-19 in a freeze-dried form is not that far-fetched.
     Bavarian Nordic is already producing a freeze-dried vaccine for rabies in the U.S. only eight months after completing the acquisition of the manufacturing and global rights to Rabipur®/RabAvert® (Rabies Vaccine) and Encepur® (Tick-Borne Encephalitis Vaccine) from GlaxoSmithKline plc (GSK).
     “Every 10 minutes a person in the U.S. starts post-exposure rabies vaccinations after a suspicious animal bite,” Bavarian Nordic said.
     Left untreated, rabies is almost always fatal.
     RabAvert is a sterile, freeze-dried rabies vaccine for both pre-exposure and post-exposure vaccination in all age groups.
     “At Bavarian Nordic, we have a compelling infrastructure that aligns with the critical vaccine market needs from basic research and development to commercial operations, manufacturing and distribution,” declared Paul Chaplin, President and CEO of Bavarian Nordic.

Freeze-Dried Beads of Hope

     Another application for serum that might see wider application comes from USA Argonaut Manufacturing Services that provides contract manufacturing for biopharmaceutical, diagnostic, and life science organizations.
     Argonaut is all cutting-edge solutions including lyophilization for reagents and barrier isolation technology for parenterals.
     The Argonaut manufacturing site is located in Carlsbad, CA (45 minutes north of San Diego).

An Ambient Advantage

     Argonaut insists transitioning serums from liquid solutions to its product branded “LyoDose” either in beads or lyophilized powders “can generate significant technical advantages.
     “LyoDose beads are spheres of customizable lyophilized material that contain a specified volume of material per reaction, while maximizing surface area for rapid reconstitution,” the company said.
     Argonaut claims, “the operational benefits are great and may encompass lowering cold chain costs with room temperature storage ,cutting waste by reducing carbon footprint (Green Initiatives).
     In application the company notes fewer user errors by reducing mixing steps and service calls as well as preventing obsolete inventory by extending shelf-life.
     “Sometimes conventional powders are preferred applications, and Argonaut delivers these with the same room temperature storage and stability as LyoDose beads,” the company said.
     Argonaut said it is currently able to produce “500K+ LyoDose beads per week, and most recently had been scaling production up to 1M+ per week.”
     While those numbers seem like a drop in the bucket measured against the scale of need for vaccines and therapeutics to defeat COVID-19, a common complaint about the current ability worldwide to provide this lyophilized antidote, we recall last February that the world did not have enough ventilators.
     But thinking about the need from high tech to a company down in New Zealand, to a totally Pharma-focused company up in Kingston, New York and in Carlsbad and undoubtedly many places in between recalls in recent history how the Ford Motor Company in Detroit and some other legacy companies, both in the U.S. and abroad answered the call and changed their production and got busy making life-saving ventilator machines earlier this year.
     “It was the best of times, it was the worst of times,” are the opening words of Charles Dickens epic novel A Tale of Two Cities.
     In 2020 our hope is that the best will come from the worst.
Geoffrey

Hi Geoffrey,

     Thanks for your good questions and I hope that you and the family are well and staying safe. My dad taught me a lesson he learned while fighting in WW II. He always said that you can tolerate anything as long as you know an end is coming. That good advice is certainly appropriate today.

Every good wish,

Brandon
Brandon Fried
Executive Director
Airforwarders Association

Q.  What must the air cargo business do now and post pandemic to come back stronger than ever?

BF.  We should not fall into the trap of thinking that we can just hit the “play” button and business life as we know it, will resume immediately. Some trade industry segments will rebound quickly but others will be slow to recover. When we do get back to work, a different world awaits us.
     In response, forwarders and our partners will do what we have always done best, and that is listening to our customers and adapting to their changing needs. My advice is to reflect on how you fared compared to your competition and take those lessons learned to heart.

Q.  What have we learned with Cargo In Cabin (CIC)?

BF.  The Airforwarders Association’s forwarder members are thankful to our airline partners for stepping up and offering their passenger planes to fly flights with just cargo. We are certainly reminded of how clever, adaptable, and resourceful the various links in the air cargo chain can be. Of course, these flights are probably not sustainable as it is hard to imagine taking my usual seat 22B only to find boxes strapped on either side of me! But perhaps the industry should take a step back and consider reviving the “combi” or “quick change” aircraft of yesteryear.
     I would imagine that in the future, cargo divisions of the major airlines will enjoy newfound respect at the board table. For many carriers, cargo has certainly been a revenue lifeboat during this challenging time.

Q.  Do you have a hero? Please describe.

BF.  Without question, my absolute hero is my wife Kim for putting up with me working from home during the past weeks. Other heroes include the hard-working Airforwarders Association members. These people have been on the frontlines of the pandemic, responding to the challenges of delivering essential medical supplies, fresh foods, and vital parts and equipment to keep hospitals and factories running.
     Forwarders and their complex logistics networks will lead the way to a full economic recovery.

Q.  An August Report Card

BF.  Addressing the issue of staffing, 43.2% report some level of personnel cutbacks ranging from modest to “bloodbath.”
    Over 62% of the members have indeed applied for federal relief (PPP or other program).
     Will this be enough? Clearly the jury is still out but close to 74% think it will bring some relief, but indications are this will fall short of keeping the industry whole.
     Over 86% of respondents surveyed said they have pivoted to new industry silos in addition to their traditional markets.
     As to what lies ahead, over 92% are cautiously optimistic about future business.

Q.  Have the passenger aircraft conversion to freighters helped?

BF.   The results have been truly mixed; dependent in most cases on the market segment(s) in which they specialize, although just under 70% have reported some degree of usage of the program.

Q.  Where and for what have these “freighter” operations helped?

BF.  Geographically we are seeing a mix between the U.S. Asia and the U.S. and the EU.
     As for commodities, not surprisingly most are centered around medical supplies and pharmaceuticals.

Q.  How do folks see the remainder of 2020 playing out:

BF.  At this point, forwarding is now a tale of two worlds with a common thread. One world consists of those fortunate forwarders who had made significant investments in the medical industry and continue to manage substantial shipments consisting of personal protection equipment (PPE), medical machinery, and pharmaceuticals.
     The other world includes those forwarders specializing in market niches closed by the pandemic, including trade show, entertainment equipment, and museum exhibit transportation. Still, as the survey indicates, many have responded to the challenges by moving into other, more lucrative markets to survive while the crisis lingers. The common thread is the creativity and resourcefulness of forwarders who continue to thrive, even in the face of such unprecedented adversity.

Editor's Note: The last meaningful gathering of 2020 was the Airforwarders Association Annual Conference in Nashville at the end of January. By now we should have seen Brandon at least two or three times at various venues since cancelled.
     Since it looks like the rest of the calendar for 2020 everywhere else will be scrapped maybe we won’t see him again until next year.
     Brandon is a spark plug, but right now from his perch just near the halls of U.S. government in Washington, D.C., we imagine he has his hands full keeping things going for the U.S.-based Airforwarders Association.
     More power to him with thanks for his always informative and insightful comments here.