Blog
The pharmaceutical landscape is evolving rapidly with the introduction of platform technologies, often enhanced by machine learning (ML), and Ingenza is one of the few contract, research, development and manufacturing organisations (CRDMOs) to embrace this approach. Ingenza’s inGenius® platform plays a pivotal role in accelerating drug substance development, particularly as we tackle increasingly intricate processes and complex modalities. In this blog, Masha Kononov, Director of Business Development at Ingenza, explains why Ingenza decided to invest in an adaptable platform technology, and how this is essential for keeping pace in this dynamic field.
Platform technologies drive efficiency in therapeutic innovation
The demand for innovative therapeutics is rising and, with that, pressure mounts to find more efficient ways to identify and develop promising drug candidates from extensive libraries, both physical and in silico. This means that the traditional approach pharma companies have taken to discover and develop individual molecules is gradually giving way to a more standardised suite of technologies designed to support multiple assets.
In response, the industry is increasingly investing in advanced tools capable of rapidly screening large volumes of molecules. Drug discovery platforms – integrated systems that can assess multiple candidates in parallel – are now frequently enhanced with AI and ML to generate high quality data at an unprecedented rate. This combination of platform technologies and AI is enabling unparalleled precision and efficiency in drug discovery, marking a significant shift in industry standards. Their value has been noted by investors, with start-ups using platform technologies attracting over two-thirds of venture capital biotech funding from 2019 to 2021, a global investment totalling $34.6 billion.1
Navigating the complexity of emerging drugs
These AI-driven platforms are unlocking new drug modalities that hold promise for overcoming the constraints of traditional therapeutic approaches. As a result, the drug discovery field is rapidly expanding to include more complex molecules, such as antibody-drug conjugates, peptides, fusion proteins, vaccines, chimeric molecules designed for targeted protein degradation and many more. For instance, bispecific antibodies (bsAbs) have seen significant growth, with over 50 candidates reaching clinical trials in 2021.2
However, it is fair to assume that these sophisticated modalities often introduce unique challenges for product development and CMC, largely due to the absence of historical reference points. Manufacturers need to invest time and money to establish new critical quality attributes, process controls and analytical assays, as there are no established templates for these advanced molecule types.
The inGenius® platform solution
CRDMOs have traditionally relied on more conventional methods of drug discovery and development, which is challenging for these novel complex modalities. These approaches are time consuming, resource intensive and are often unreliable. At Ingenza, we have adopted a more agile way of working to accommodate high molecular diversity and complexity, while simultaneously addressing the constraints of time, cost and scope. The inGenius® platform integrates several elements to develop and optimise bioprocesses for a range of complex biologics and small molecules, including:
- Multiple efficient, proven biomanufacturing hosts
- ML-based customised gene design
- A comprehensive library of genetic elements
- Advanced genome editing tools
- FACS-assisted optimisation of protein expression
- Customised fermentation
With the inGenius® platform, we can develop efficient, robust and compliant bioprocesses that support investigational new drug (IND) readiness, ensuring future manufacturing meets productivity, quality and cost standards. An excellent example of this is our contribution to the production of a recombinant coronavirus vaccine with cross reactive immunity, where the inGenius® platform was used to enhance the development of bioprocesses for eight antigens and one nanoparticle. By streamlining process development, Ingenza’s approach accelerates candidates’ progress toward clinical trials and helps mitigate investment risks for our partners.
Interested in finding out how we can help your project? Contact us today.
- McKinsey and company. (2021). What are the biotech investment themes that will shape the industry? https://www.mckinsey.com/industries/life-sciences/our-insights/what-are-the-biotech-investment-themes-that-will-shape-the-industry
- Kinch, M.S., Kraft, Z. & Schwartz, T. Immunoconjugates and bispecific antibodies: trends in therapeutic success and commercial focus. Drug Discov. Today 28, 103462 (2023).