We are building a state-of-the-art biotechnology development and manufacturing platform in Latin America.

Our vision is to enable Latin America to play a leading role in the development of next-generation biological therapies and to quickly respond to any biosecurity threats.

THE CHALLENGE:
BIOLOGICS INFRASTRUCTURE GAP IN LATIN AMERICA

Latin America is currently focused on the production of generic drugs and lacks basic infrastructure for the development and manufacturing of advanced biologics. The resulting reliance on foreign imports of biologics leads to supply constraints, inflated drug prices, and vulnerability to demand shocks. The region is also not able to help alleviate threats to global supply chains.

Brazil and Latin America do not have a large-scale rapid response biomanufacturing infrastructure to address future biothreats including pandemics and bioterrorism. The region is almost exclusively dependent on state/government infrastructure and international suppliers to deploy foreign drug products.

FIRST ORDER EFFECTS

Latin America cannot currently produce biologics at scale

With 8.7% of the global population but only 2.7% of the world’s capacity in biologics manufacturing, Latin America has significant capability challenges.

Sources: Langer ES, et al. 2020 Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, 17th ed.

SECOND ORDER EFFECTS

Limited therapies, high drug prices, vulnerable population

Prices for biologics are high due to the need for importation from overseas. While biologics represent less than 5% of the Brazilian government’s drug purchases, it represents over 50% of its drug purchase budget.

Lack of supply of biopharmaceutical products to the population. Brazil only produces roughly 10 biosimilars regionally.

Brazil relies heavily on the government for essential therapeutics. Approximately 90% of all vaccines produced in Brazil are manufactured in in-state government facilities. However, these facilities have multiple competing priorities and there is no relevant private sector support.

Vulnerability during health crisis and pandemics. It took Brazil 2.5 months longer than the US to vaccinate 50% of its population. 122,508 died during this period.

No bio protection stockpiles against future biothreats. While Brazil has no access to stockpiles, the US bio protection inventory amounted to US$5.6B (pre-COVID), covering anthrax, ebola, smallpox, influenza, and other threats.

BioShield Life Sciences is building Latin America’s first large scale, state-of-the-art Contract Development and Manufacturing Organization (CDMO) to develop and produce advanced biologics and vaccines under contract from public and private entities.

OUR SOLUTION:
ADVANCED BIOLOGICS CDMO

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WHAT ARE BIOLOGICS?

Biologics are advanced drugs and vaccines produced through biological processes. They are the most advanced therapies available for serious diseases such as various cancers, diabetes, Crohn’s disease, multiple sclerosis, anemia, asthma, cystic fibrosis, and others.

BIOSHIELD PLANNED PRODUCTS

BioShield’s technology and infrastructure will enable the production of several biopharmaceutical end products. They can be manufactured under contract, under a partnership, or in-licensed. Examples of these products include:

Monoclonal antibodies (Novel & Biosimilars)

Therapeutic proteins (Mammalian & Microbial)

CAR-T-Cell Therapy

Other Cell & Gene Therapies

Stem Cells

Biologic Therapeutics

Novel vaccines to prevent emergent infectious diseases

mRNA

Self-replicating RNA

Virus-Like Particles (VLP)

Adeno-Associated virus (AAV)

Modified Vaccinia Ankara

Lentiviral vectors

Baculovirus

High demand vaccines for the regional population

Coronavirus vaccine

Influenza virus vaccine

Dengue vaccine

Zika virus vaccine

Chikungunya virus

Malaria vaccine

OUR BUSINESS APPROACH

BioShield’s commercial strategy will revolve around 5 main themes.

Provide development services to the innovators of biologic-based medicines. Produce clinical trial materials.

Biologics Development

Provide vaccine development services to prevent emergent and existing infectious diseases utilizing a variety of technological platforms.

Vaccine Development

Offer the private sector (hospitals and physicians) and institutions solutions for the development of these novel therapeutics.

Cell and Gene Therapy Development

Technology transfer and manufacturing of cutting-edge biologics (monoclonal antibodies, therapeutic proteins), vaccines, and C&G therapies.

Large Scale Manufacturing

Aseptic Fill and Finish for drug products in vials, syringes, and cartridges. Aseptically filled cGMP-certified drug products can be used for clinical trials or for commercial purposes. Intermediate warehousing of the drug products at various temperatures (RT, +4°C, -20°C, and -80°C) will be provided.

Aseptic Fill and Finish Services

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BENEFITS OF A CDMO IN LATIN AMERICA

Brazil and Latin America is highly vulnerable to biological threats. The country does not have the necessary infrastructure to implement a bio protection strategy. BioShield will be capable of producing and supplying biologic stockpiles to protect the population and economy from biological black swan events.

A few examples:

Influenza Viruses (Avian, Swine)

  • Greatest effect on populations because of pandemic possibilities.

  • Frequent global inventory problems. Butantan and Fiocruz are well equipped to manufacture vaccines but rely on API supplies.

  • Novel influenza viruses are created constantly by mutations or gene exchanges between avian, swine and human viruses.

Ebola

  • Ebola viruses (EBOV) cause severe, fatal hemorrhagic syndromes.

  • 11 countries are already affected.

  • Mortality rates vary from 25% to 90% across 5 different strains.

  • Brazil does not have access to even basic Ebola tests, much less vaccines and therapeutics.

Smallpox

  • An estimated 300 million people died from smallpox in the last century.

  • Smallpox is known as being simple to weaponize. Vials stored with smallpox virus exist in various countries.

  • Mortality rate is 30% (at least 10x higher than SARS-CoV-2).

Anthrax

  • Anthrax is simple to weaponize. An Al Qaeda laboratory and detailed plans to produce Anthrax spores were found in Afghanistan.

  • Lethality rate is 75-90% if untreated and still 40-50% if aggressively treated with antibiotics.

Just like it had never anticipated a pandemic, Brazil and Latin America currently does not anticipate biological terrorism. 

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FAQ

  • Ability to expand product line and react rapidly to demand shifts, pandemics, and regional health crisis.

  • Strategic positioning that addresses the biologics infrastructure gap in Latin America.

  • The region is vulnerable to pandemics and biosecurity shocks. Additionally, Brazil has significant labor and regulatory competitive advantages. Current reality strongly supports regional capacity in addition to major global production centers.

  • There is a need to provide advanced, regionally unavailable, state-of-the-art biopharmaceutical therapies to deal with the most aggressive present day diseases (cancers, Crohn’s, multiple sclerosis, etc.).

  • We have entered the age of pandemics and the age of biology.

    Latin America has the opportunity to be at the forefront of a new technological frontier. With a competitive advantage in operating cost and regulatory environment, the region has the capacity to develop and manufacture advanced biologics to enter this new age.