Menzo Havenga, President and CEO
The recent scientific breakthroughs in the biopharmaceutical product space—including checkpoint inhibitors and CAR-T technology—have spurred the development of novel product classes such as oncology vaccines and gene therapy products. While this evolution has opened the doors toward a healthier and safer planet, it has also highlighted a significant lack of capacity and know-how in the field of viral vaccine and vector manufacturing resulting in low product yields and high production costs. This has, in turn, resulted in a high cost of certain vaccines and recombinant proteins, hindering people access to a proper cure for a certain disease. The current scenario in the biopharmaceutical product space has made it imperative for the CMOs to find ways to scale and address the growing consumption of medicines.
By offering a groundbreaking low-cost manufacturing technology, HIP-Vax™, Batavia Biosciences is addressing the low product yield from current manufacturing processes. “To achieve substantial cost savings for novel product lines, novel manufacturing technologies, able to significantly intensify the production process, are deemed pivotal, and that’s where we are the changing the game,” says Menzo Havenga, the president and CEO of Batavia Biosciences.
Batavia Biosciences provides improved success rate and production processes which lower the cost of goods for its clients and in this way support the transition of biopharmaceutical product candidates from discovery—through R&D and phased clinical trials for acquiring insights about safety, dosage, efficacy and side effect, and in parallel, monitoring adverse reactions— to clinic.
The attrition rate in the development of novel biopharmaceuticals is substantial with only about 5 percent successfully making it through the R&D phase into Phase 1 clinical trial testing, 63 percent moving forward to Phase 2 clinical trials, 31 percent moving to Phase 3 and less than 50 percent moving forward to either Phase 4 (post-market approval surveillance) or market introduction.
“The R&D phase has the highest attrition rate by far with many putative products not progressing successfully into a regulatory approved Investigational New Drug dossier (IND), which is pivotal to embark on phase 1 clinical testing,” states Havenga. To address this, Batavia Biosciences employs state-of-the-art laboratory infrastructure both in the Netherlands (Leiden) and U.S. (Boston) and is well equipped to develop any biopharmaceutical, be it an antibody, recombinant protein, viral vaccine or viral vector from early discovery to clinical manufacturing. Batavia Biosciences has a broad client base working with biotech companies, multinational biopharmaceutical companies, and not-for-profit organizations, including academia, government, and charitable organizations.
The growth success of Batavia Biosciences (33 percent CAGR) is based on the fact that it has been successful in building a renowned world-class R&D organization (+100FTE) that understands the challenges associated with biopharmaceutical product development. It is thus well-positioned to bring realistic and practical solutions to sponsors and collaborators. Further, Batavia also actively develops a range of tools and technologies to facilitate the development and manufacturing of biopharmaceuticals at reduced cost and accelerated timelines. Examples of such technologies are its SCOUT®, SATIRN®, SIDUS®, STEP®, and SCOPE® technology platforms that allow, early in the product development chain, a thorough understanding about manufacturing challenges associated with the novel compound.
Batavia Biosciences utilizes its resources to develop novel, better, or cheaper vaccines in close collaboration with organizations such as the World Health Organization (WHO), Bill & Melinda Gates Foundation, National Institute of Health (NIH) as well as many prominent academic institutes. Examples of countermeasures that Batavia is currently developing include novel vaccines against measles virus, chikungunya virus, and Ebola virus or potent virus-neutralizing antibodies for protection against, for instance, Zika virus.
With a clear growth strategy that entails doubling its R&D capacity within the next six years through organic growth, Batavia Biosciences will be growing its R&D infrastructure in both the U.S. and Netherlands. In addition, the company wishes to further expand its manufacturing capability for which it will commission a multipurpose, multi-suite GMP manufacturing facility employing approximately 40-50 experienced staff.