Safe delivery in all climates

Discover Ziccum technology, now—and into the future Ziccum’s active, dry-powder formulations could help democratize delivery of biologic therapies from viruses to antibodies to proteins to vaccines. Discover Ziccum here, now and tomorrow.

VACCINES

Cracking the Cold Chain

VACCINES: The global need

  • 1-in-5 children worldwide still fail to receive even basic vaccines
  • 1.5 million children die every year from vaccine-preventable diseases
  • 20 million children are dangerously under-vaccinated

(World Health Organisation) The vast majority of today’s vaccines are developed as injectable liquids, making them highly sensitive to temperature fluctuation. Every step of the way from plant to patient they need to be kept constantly refrigerated, using expensive industrial “cold chain” systems that add hugely to their cost. The result of this Cold Chain dependence? Many of the world’s most vulnerable children still fail to get the vaccines they need.

Safe delivery in all climates

“Imagine if vaccines didn’t have to be formulated as liquids. Imagine if they were cheap, safe, fast and agile to transport with no cold chain necessary, and nothing holding them back.

Imagine the suffering that could be prevented, the costs that could be avoided and the communities and societies that could be set free. That, ultimately, is what Ziccum technology can deliver.”GÖRAN CONRADSON, ZICCUM CEO

REVEALED: The real costs of the Cold Chain

Just as all vaccines, and patients, are different—so too is every country and region administering them. The cost of storing and administering vaccines varies enormously from region-to-region, country-to-country and government-to-government. And context is crucial. Whether the vaccine is part of a scheduled campaign, or a response to an outbreak, has a big impact too.

Cost vs. contagion: What price vaccine?

But even given this, overall the cost of vaccines per person remains significantly higher than wished for, and a disproportionately large amount of the total cost goes to the Cold Chain.

Let’s take an example: In 2016 the WHO released a detailed breakdown of the real costs for an Ebola vaccination campaign that had inoculated 24,875 people.
It showed both the high cost per person (‘vaccinee’), and the large amount of total costs devoted to the Cold Chain:

EBOLA VACCINE COSTS, WHO

  • Cost of vaccine per person: 135 USD
  • Cost of Cold Chain as proportion of overall costs: 1.09 of 3.38 MUSD – almost 1/3

Policy making around vaccines is complex, tough and different everywhere, with all regions having their own unique challenges and priorities.

But with the Cold Chain currently requiring such high electricity costs—almost a third of total vaccination program costs—in areas that often have low electricity coverage, and require electricity for a range of urgent, diverse needs, being able to eliminate Cold Chain spending from the total cost of vaccination would be a major step in reducing costs and complexity—and increasing opportunity.

Managing the Last Mile

Crucially, dry powder vaccines open up powerful opportunities for faster, more agile and more cost-efficient transport of vaccines in the critical last mile of the supply chain. It is here where the impact of the cold chain often hits hardest. For remote rural areas with few resources, keeping complex refrigeration systems in place is a challenge:

  • Only 10% of health care facilities in the world’s poorest countries have a reliable electricity supply
  • Over 70% of health care facilities have inadequate access to mains power in Uganda, as an example
  • UNICEF estimated that 1.5 MUSD of vaccines were lost in five months in 2011 due to difficulties maintaining cold chain vaccine supplies to remote locations

Dry powder formulations require no special refrigeration or freezer equipment for storage or transport. Light and compact, they can be stored and transported safely and efficiently over any terrain by drone, moped or light aircraft. The active ingredient stays active. So when the powder is reconstituted with water at the injection site—it is ready to administer.

Dry powder vaccines: 4 need-to-knows

REVEALED: The Real Cost of the Cold chain 17 USD: average cost per vaccinated child (2017)-

  • 1-3 USD: actual cost of vaccine per dose
  • 14-16 USD: admin’ and maintenance costs of Cold Chain More than 50% of vaccines may be wasted globally every year

(WHO) because of temperature control or supply chain issues (GAVI, the Vaccine Alliance)

  1. Ziccum develops vaccines as robust, temperature-resistant dry powders, with the active ingredient still intact.
  2. Ziccum’s dry-powder versions of live vaccines require no refrigeration or cold chain during transportation or storage.
  3. Ziccum’s dry-powder version of Adenovirus stayed active at +40° C for over a week, outperforming the WHO’s CTC (Controlled Temperature Chain) classification that requires vaccines to tolerate temperatures of +40° C for three days to increase the world’s vaccinated population.
  4. Ziccum’s vaccine formulations can be transported as powders, then diluted back into liquids at the point of inoculation—avoiding Cold Chain maintenance costs and significantly reducing the cost of vaccines. Up to 16 of the 17 USD cost of vaccination per child is currently spent on administering and maintaining the Cold Chain.

BIOLOGICS

From proteins to peptides to antibodies–biologic therapies include many of the world’s most advanced and effective treatments. Yet 80% are still formulated as liquids. This makes them expensive, and fragile to store and take on the move for today’s modern patients.

  • Over 95% of conventional drugs are in robust, easy-to-store dry form
  • Only 20% of vaccines, antibodies, peptides and proteins are in dry form
  • 20% of the world pharma market cannot adequately store liquid therapies

Blue sky biologics: medicines on the move

For patients with permanent conditions that require regular treatment, temperature-sensitive liquid injectables can restrict their mobility and working life. It can leave them feeling defined only by their condition, and treatment. When Ziccum formulates biologic therapies as dry powders it increases the stability, longevity and, crucially, the mobility of the treatment: Therapies last longer. Plus, they can be stored and transported as dry powders with no need for special refrigeration or protection, whether personally by a patient, or in bulk—then simply re-constituted for administration whenever needed or convenient.

Blue sky biologics: Case Study

PREVENTING THE UNPREVENTABLE: GENE THERAPY DRY POWDER ADENOVIRUS Many of the most punishing and fatal conditions in the world today are hereditary. And, until now, unpreventable. Devastating genetic diseases like Parkinson’s, cystic fibrosis, muscular dystrophy and Huntingdon’s cut lives short and require years of constant, complex clinical management. Gene therapy promises a preventative cure. An advanced biologic therapy, it ‘sets a thief to catch a thief’’. Gene therapy uses an immune, resistant or healthy gene to replace or ‘fix’ the mutated gene causing the conditions. Worldwide the race is on to advance gene therapy for the treatment of diseases that have no other cures. In 2018, 2600 gene therapy clinical trials were completed, approved or ongoing globally. ADENOVIRUS FOR GENE THERAPY: 5 KEY ADVANTAGES

  1. adenovirus is ubiquitous. Most adult human have been exposed to the kinds of adenoviruses used in gene therapy at some time in their lives.
  2. adenoviruses are versatile. They infect a broad range of human cells and yield high levels of gene transfer compared to other alternatives.
  3. adenoviral vectors have low pathogenicity in humans: they cause few and only mild symptoms associated with the common cold.
  4. adenoviruses can take relatively large segments of DNA (up to 7.5 kilobase pairs [kb]) and transduce them into non-proliferating cells.
  5. the viral genome is stable, inserted foreign genes can be maintained without change through successive rounds of viral replication.
  6. adenoviral vectors are easy to manipulate using current recombinant DNA techniques.

Adenovirus is one of gene therapy’s most promising tools.

But despite several advantages there is a major drawback for researchers. In its current liquid state, adenovirus is highly sensitive to temperature fluctuation of any kind. This instability requires the adenovirus to be deep frozen at up to -800 C, a major obstacle to commercialization. It makes it difficult to store and transport, both for clinical trials and administration. The development of a dry powder formulation of adenovirus that could be stored and transported at +40 C for at least a week would greatly broaden the uses of adenovirus in clinical trials, offering a more stable, robust version of the trial substance that could be administered to more subjects in a more robust state.