In a white paper for IDT Biologika Dr Andreas Neubert explores how viral vectors offer a host of opportunities for vaccine development with the right conditions and collaboration. He describes the expanding “conversation” around vector-based treatments over the last 20 years. Since their development two decades ago, he states that their “value has become more apparent”. They present opportunities for both prophylactic and therapeutic treatments, yet “many drug manufacturers still do not have the means to scale up their production”. Thus, companies must use contract development and manufacturing organisations (CDMOs).
Special needs
Dr Neubert reflects that among the “many hurdles” involved in driving vector-based treatments to market, a significant challenge is “access to the necessary facilities and equipment”. Production of vector-based therapies relies on “access to cell lines, cell characterisation and analysis resources, cell propagation in cell factories, and fermenting systems”. Expertise is essential to scaling up viral vectors, to create systems for “optimal yields and potency as well as safety”. 20 years ago, when vectors emerged, the “standard equipment” for vaccine production was stainless steel. According to Dr Neubert this doesn’t provide the necessary flexibility. Single-use technology (SUT) “affords greater flexibility”, he states, but is expensive and often “fails to meet the scale and standards” required.
Further requirements relate to the consequences for patients: “when characterising cells lines, developers must ensure that they contain no indigenous or adventitious viruses, no tumorigenicity, and no potential to cause harm in patients”. Dr Neubert insists on the importance of “functional” vectors that “carry no microbiological or viral contamination”. The equipment used for manufacturing must be “reliable’ and perform accurately. Each step of the process brings more complications. For example, “fermentation and purification steps” can “adversely affect virus propagation”. Highly specialised conditions are also necessary for freeze-drying or storage, even the final manufacturing processes.
Understanding is vital
Although he recognises the speed of the development of Covid-19 vaccines “seems remarkable”, Dr Neubert considers it to be “on par with the standard rate of development”.
“The science behind the vaccines now on the market began about 10 years ago”
Evolving tools and technologies enable us to keep up with increasing knowledge to develop vaccines. In contrast to traditional vaccines, which often contain elements that “suppress or modify” immune responses, viral vectors are “well-known to be safe in humans”. They also provide “more options for eliciting a specific reaction”.
As well as prophylactic solutions, viral vectors have potential for gene therapy. In these cases, vectors with “low immunogenicity” are used. Dr Neubert recognises that the current state of viral vector knowledge “emerged from setbacks as much as successes”. However, it is also a result of IDT Biologika’s “collaboration with partners and customers across the world”, he says.
“IDT Biologika has worked since 1997 to help numerous companies and academic institutions develop vector-based products”.
Partnerships promote learning
IDT Biologika works with partners in across the industry to “design and improve the specialised spaces and systems” needed to manufacture and scale up. A current challenge is the development of a vector-based vaccine against Covid-19. Hoping to reduce side effects and increase immunity, the developers are using a vector that has been “proven safe in humans for nearly 20 years”. As well as design and development, IDT Biologika provides “guidance and support” to partners.
Dr Neubert’s conclusion
Although viral vectors have been around for two decades, their “potential applications are still largely unexplored”. This presents the industry with room for further research and development, despite the complex nature of managing the products. Dr Neubert reflects that equipment and expertise are necessary, recalling the importance of partnerships. However, the most important factor for success in his mind is “a spirit of collaboration and a willingness for developers, manufacturers, researchers, and CDMOs to learn together and build upon their shared experience to advance this exciting science”.
To hear from IDT Biologika’s Senior Vice President of Development, Dr Simone Kardinahl, at the World Vaccine Congress in Europe 2022 click here for tickets.
For the full paper by Dr Neubert, click here to download a copy.
