Recent years have underscored the importance of large-scale vaccine development within the biopharmaceutical industry. Nevertheless, the scope of biomanufacturing extends far beyond vaccines, encompassing a spectrum of biopharmaceutical products that are well-placed to revolutionise healthcare.
Biomanufacturing represents a new horizon in pharmaceuticals, offering the promise of efficiently producing complex medicines, vaccines and therapies.
In July this year, 23 new cell and gene therapies (CGTs) were in line for approval throughout the European Union and the United States, and we are beginning to hear more regular accounts of their real-world impact on patients.2
Collaboration as a catalyst for innovation
When we look to the successes within the biomanufacturing sector, it’s clear that collaboration transcends statistics, emphasising its pivotal role in unlocking biomanufacturing’s potential.
The exchange of ideas and knowledge among stakeholders lies at the core of innovation in biomanufacturing.
Discussions encompassing novel applications, efficiency boosting technologies and essential workforce training not only enhance productivity, but also empower biomanufacturing organisations to confront industry challenges.
Collaboration is not a mere buzzword; it is an imperative in the realm of biomanufacturing. It acknowledges that no single entity can master all facets of this intricate field.
Biomanufacturing encompasses a myriad of disciplines, including molecular biology, process engineering, quality control and regulatory compliance.3
Collaboration enables experts from diverse domains to converge, share insights and collectively push the boundaries of what’s achievable.
For instance, the recent advancements in the CGT sector provide a clear example of how collaboration can achieve results. CGT has emerged as a revolutionary branch of medicine, offering treatments that can target hereditary diseases, genetic disorders, autoimmune diseases and cancers at a molecular level.4
However a recent EY survey highlighted the necessity of the sector to embrace and instil a culture of continued collaboration — with 97% of participants agreeing that greater levels of collaboration in an industry that is inherently competitive are essential to successfully scaling CGTs, and nearly a third citing industry culture as the biggest barrier.3
As we all know, substantial growth necessitates significant investment. However, biomanufacturing companies can optimise their ability to develop innovative products by pooling capital and resources through collaboration.
This co-operative approach allows for the swift and efficient global rollout of groundbreaking healthcare solutions and industry standards.5 Such standards ensure the safety, quality and consistency of biopharmaceutical products.
Moreover, collaboration fosters innovation in process development and optimisation, leading to more efficient and cost-effective production methods.
Guiding biomanufacturing’s trajectory
Given some of the ethical concerns and doubts surrounding the financial viability of biomanufacturing, effective regulation is paramount.
The facilitation of an ongoing dialogue among industry stakeholders supports the development of coherent and ethically sound policies. Continuous discussion and shared understanding are prerequisites for successful policy making in this transformative field.
Recent years have highlighted the significance of being able to rapidly develop effective vaccines on a large scale. However, the scope of biomanufacturing extends far beyond vaccines, encompassing fusion proteins, amino acids and biopharmaceutical products such as CGTs.
Collaboration between the pharmaceutical and biomanufacturing sectors can pave the way for the development of a wide array of innovative healthcare solutions, ensuring that they are available as and when needed to serve global healthcare requirements.
Consider the scenario of regulatory challenges in the CGT sector. The lack of standardisation and clear regulation in CGT manufacturing has hindered its growth.6
The absence of clear and binding standards for CGT therapies has led to slow approvals, raising concerns about patient safety and legal costs for developers. There is currently no strong set of international standards governing chemistry manufacturing and controls (CMC) within the CGT sector.
The European Medicines Agency (EMA) and the US FDA have issued industry guidelines, but these are mostly non-binding and have been criticised as vague.6,7
As the industry expands and new therapies emerge, regulatory agencies must adapt to ensure the safety and efficacy of these treatments. Open communication between industry experts and regulators is crucial to strike the right balance between innovation and patient safety.
Ethical considerations play a significant role in biomanufacturing. As we harness the power of biology to produce therapies, questions about genetic engineering, human gene editing and the implications of altering living organisms arise.
Discussions involving ethicists, scientists, policy makers and the public are necessary to navigate these complex ethical challenges.
Shaping the future of healthcare
With visionary leadership and a commitment to open dialogue, the industry can navigate the challenges and opportunities presented by this transformative technology.
The fusion of pharmaceutical expertise with biomanufacturing innovation heralds a future in which healthcare is revolutionised, saving and improving lives on a global scale.
Collaboration isn’t just an option; it's an essential catalyst for progress in biomanufacturing, shaping a brighter future for healthcare.
The collective efforts of industry leaders, policy makers and innovators will drive biomanufacturing’s scalability, transforming it from a promising concept into a reality that benefits patients worldwide.
However, collaboration is not limited to industry stakeholders alone; it involves engaging with the broader community, including patients and advocacy groups.
At IMAPAC, we aim to facilitate this dialogue through our industry conferences, annual committee meetings and speaking events — which provide an essential forum for stakeholders to discuss the future of the CGT sector.
These voices provide valuable insights into the real-world impact of biomanufactured therapies and help to shape the future of healthcare.
References
- www.globenewswire.com/news-release/2023/06/08/2684853/0/en/Innovations-That-Matter-Next-Generation-Biomanufacturing-Technologies-You-Can-t-Ignore.html.
- www.lse.ac.uk/business/consulting/news/gene-therapies.
- www.ey.com/en_gr/life-sciences/what-might-cgt-achieve-through-industrialized-collaboration.
- www.mckinsey.com/industries/life-sciences/our-insights/a-call-to-action-opportunities-and-challenges-for-cgts-in-europe.
- www.mckinsey.com/industries/life-sciences/our-insights/reimagining-the-future-of-biopharma-manufacturing.
- www.genengnews.com/insights/cell-and-gene-therapy-sector-needs-cmc-clarity/.
- www.biospace.com/article/cell-and-gene-therapy-market-size-growth-trends-forecast-report-2022-2030/.