Collaboration Is the Key to Efficient Product Development
Industry Insight Dec 11, 2020 | By Dr Leonardo Magneschi, Ingenza Ltd, UK.
It’s not always easy to take novel ideas from concept to market, as there are numerous hurdles to jump when developing new therapeutics and technologies. Many researchers are now realizing the power of collaboration, bringing together creative ideas and complementary expertise to ensure that projects meet their end goals. This approach can bring refreshing innovation to the development process, combining tried-and-tested traditional methods with the latest breakthroughs and technologies. Outsourcing certain aspects of experimental work to biotech companies with vital experience in relevant areas can help to advance products more rapidly, accelerating time-to-market and ensuring success.
Biotechnology encompasses many fields, and it is easy to focus on just one aspect of a research project at a time, slowing overall progress. Many companies with in-house molecular biology and biotech expertise are well aware of this potential bottleneck and embrace the benefits of outsourcing to specialist biotech CROs, supplementing internal resources for a specific phase of a research project. At the other end of the R&D spectrum, numerous companies in the pharma and chemistry sectors are looking to move away from petrochemical feedstocks and implement greener, more renewable processes. Often, they have limited knowledge of how to achieve this, and require external expertise for bioprocess development. Regardless of an individual lab’s understanding of bio-based process development, collaboration or outsourcing can provide specialist knowhow to drive research forward at a faster pace.
Fully integrated, multidisciplinary teams
A fully integrated, multidisciplinary organization can provide the complete skillset necessary to support any stage of development, from proof of concept to scaled-up manufacture under GMP conditions. Expertise in working with a variety of host expression organisms is highly beneficial, as each host has very specific capabilities, and an understanding of these various strengths at the outset of a project can be essential to minimize repeated work and maximize downstream success.
A key advantage of multidisciplinary expertise is that it allows many different phases of a research project to be supported under one roof. Molecular biology – including vector design, and plasmid and recombinant strain construction – is just the first step of the process. Once a new strain has been created, it is just as important to ensure that it will be economically viable and perform as expected on scale-up. This is where fermentation knowledge is essential, combining broad process development understanding with scale-up expertise to guide the optimization of bioprocessing conditions and create sustainable, scalable processes. Finally, an understanding of organic synthesis and analytical chemistry – including biochemistry/enzymology, downstream processing and product recovery techniques – is required to optimize post-fermentation processes and ensure the high-quality manufacture of chemicals, enzymes, or GMP-compliant pharmaceuticals and biologics.
A systematic approach
With so many disciplines, host organisms and biosynthetic approaches to consider, and associated pitfalls to avoid, it is not surprising that many new biosynthesis processes never make it to scale-up and routine production. Innovative approaches are vital to meet the current and future materials needs as we move away from petrochemical-derived synthesis, but this must be tempered with experience – and combined with tried-and-tested traditional approaches where necessary – to ensure economic viability and long-term success. A multidisciplinary, systematic approach that looks at each step in isolation and as a part of the whole bioprocessing pathway can help to ensure success. It should include:
- Definition and confirmation of optimal biosynthetic production pathways;
- Synthesis of intermediates for use in bioprocess optimization;
- Identification and resolution of rate limitations in the biosynthetic process;
- Efficient recovery and purification of fully active target molecules.
Interaction between disciplines with different areas of expertise has other benefits. Collaborative problem solving – which is still uncommon in the biotech industry – is a key part of this, allowing scientists from various sectors to jointly study a metabolic pathway. For example, a chemist may have the knowledge to synthesize a target product using the metabolites of a specific enzyme, which a molecular biologist can express in the chosen host organism. Or perhaps a particular host has been used for proof-of-concept by the client, but it is not well suited to scale-up, and there are other options that may produce a better result. These multidisciplinary research capabilities allow target protein expression to be investigated in a range of hosts, using different combinations of promoters or regulatory elements, to provide much broader and deeper process analysis, allowing the best yielding approach to be determined.
The demand for greater throughput is omnipresent, and this has led to significant innovation in the high throughput screening (HTS) space, including the development of novel plate-based colorimetric or fluorometric assays that can provide rapid, quantitative or semi-quantitative assessment of target protein expression across a large number of clones. Regardless of the marker or assay system used, automation is crucial to the success of HTS studies, providing the necessary throughput and reducing experimental variability to ensure high quality results. This both accelerates timelines and reduces the number of lab personnel required, increasing the probability of success while reducing costs.
Collaboration is the way forward
Developing a new biosynthesis process from the ground up can be a daunting process – even for companies with in-house molecular biology and biotech expertise – and can feel virtually impossible for those lacking the required knowhow. However, as the shift towards the use of more sustainable resources continues, many businesses will be forced to consider greener alternatives to traditional synthesis pathways reliant on petrochemical feedstocks.
Collaboration with an integrated biotech CRO can overcome these challenges, allowing companies to benefit from a holistic, multidisciplinary approach to bioprocess development – from strain construction and selection, through fermentation, to organic synthesis and analytical chemistry. This type of partnership can provide additional resources and bridge gaps in in-house expertise, leading to faster process development and, ultimately, shorter time-to-market.