Menzo Havenga
CEO, Batavia Biosciences
Biotech companies starting the vaccine development journey need to look at the whole process right from the start.
“Research shows that about 22% of novel therapeutics never progress beyond their first clinical trials, for various reasons. This includes lack of commercially viability,” says Menzo Havenga, CEO, Batavia Biosciences. Contract development and manufacturing organisations (CDMOs) typically have extensive knowledge and experience in the field. Their CMC expertise in the early development stages helps to bring this high attrition number down. Havenga, who co-founded the CDMO Batavia Biosciences after having witnessed the hurdles of outsourcing while working on vaccines and viral vector-based products in biotech companies, claims that reducing risk of failure starts with a hard think on the process from beginning to end.
Addressing the hurdles
Some of the challenges of working on viral vaccines include:
- Bench-scale processes used for generating preclinical data are not scalable. Every unit operation needs to be evaluated for its fit for purpose at perceived final scale.
- Regulatory and quality compliant raw materials and process strategies must be selected in an early stage to ensure a smooth transition from bench to clinic.
Biotech companies themselves, certainly in the start-up phase, do not have the expertise in-house to understand the manufacturing challenges. They typically focus their investment money on the expansion and solidification of their patent position(s) and to rapidly increase company value by obtaining proof of efficacy in human trials. As such, external resources like CDMOs are brought in to deliver a first manufacturing process and bring the product to patients.
Research shows that about 22% of novel therapeutics never progress beyond their first clinical trials, for various reasons.
No time to lose
The increasing world population, close proximity to animals and intense global travel all contribute to an ever-increasing number of virus outbreaks. With the current SARS-CoV-2 pandemic in mind, we know how important it is to minimise the risk of failure.
Havenga therefore advises biotech companies: “Include a CDMO early in the process to help create a robust and detailed manufacturing plan. Their experience of the regulatory landscape and technological manufacturing options that are available ensure a smooth transition from bench to clinic.”