How is the world market evolving for high throughput robotic systems, considering the basic research activities in pharma and biopharma?
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Steve Crouse
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Pharma and biopharma have successfully adopted automation in the drug discovery process. While real innovation has come from this adoption, it has created new bottlenecks in drug development. Introducing automation in drug development, both drug substance and drug product development, is where we are seeing pharma and biopharma focus their investments. This includes early development, where they are trying to shorten the time for human trials and later in development where they are trying to reduce the risk in the manufacturing process.
How has market perception changed for faster research and process development using HTR and regulation as per QbD by US FDA?
Our approach to High Throughput Research (HTR) combines: a) a statistical experimental design – including the ability to import designs from DoE software, b) material savings by miniaturising formulations and reactions, increasing the number of experiments that can be conducted with the same material c) improved reproducibility of data, comparability of data and data integrity through automation and d) powerful data management tools. This allows for a deep understanding of the design space and manufacturing risks much faster than could previously be accomplished. This supports both faster drug development and a deeper understanding of the drug product and process supporting QbD initiatives.
What challenges have Freeslate identified and how do you plan to overcome them?
Our systems go far beyond traditional automated liquid handling to address more complex research processes encountered in drug development. Applying automation to novel application areas has forced us to be innovative in how we design our automation systems. For example; for polymorph, salt selection and crystallisation studies, we have designed a crystallisation assembly, heated filter block, heated liquid dispense element, powder dispense element and universal substrate to allow for 96 samples to be analysed in parallel. Since this application had not really been addressed with automation previously, we had to design an approach basically from scratch. Other examples include automated approaches to microscale viscosity measurements or higher throughput pH measurements. Designing automation for more chemical research applications required us to invent quite a number of new approaches.
While a thoughtful approach to automating a process is critical, invention is only the first step. The systems need to perform their functions robustly. For complex processes like protein formulation, small molecule crystallisations or organic synthesis, it means the equipment needs to be thoroughly tested in real world studies with relevant samples. Along with our own internal development work, we are also working with our customers to thoroughly test these systems. This includes testing customer samples in delivering a system, using our systems to offer contract research services to leading pharma companies and collaborative partnerships, like our recent work with the medicines for malaria venture. Being able to run such a large number of diverse studies through the systems has allowed us to hone the systems for target applications.
Another challenge that took some time to overcome was data management. The large amount of data automation can just create a new bottleneck – effectively managing the data. Data generated only offers value if it can be pulled together in a way that allows for informed decision making. We designed a software package that links analytical data to sample creation and sample processing information in a centralised database to ensure data integrity and easy reporting for decision making. A number of processing steps and analysis require the use of third party equipment. We might need to use a UV/Vis plate reader for measuring protein concentration, or HPLC or XRD for analysis. We designed our software to wrap around practically any third party instruments, controlling them and then capturing all critical information back into the database and linking it to the sample information. This not only makes for a powerful data management tool, but it also provides a high level of data integrity.
Presently, how big is Freeslate’s market share in the life sciences segment and what are the new application areas you are working on?
Freeslate is a market leader for automation systems for small molecule pre-formulation and process chemistry and for large molecule pre-formulation and formulation. Our expertise in this area and ongoing discussions with customers are allowing us to recognise unaddressed bottlenecks. For biologics formulation for example, we have identified a bottleneck in the visual inspection of vials and visible particle detection. Scientists are literally spending hours looking for visible particles in vials and recording the number of particles they see. There is no stored image that can be referenced later, and the potential for variability from one scientist to another is high. We designed an automated approach for this visible inspection. The system automatically spins a vial and counts the number of visible particles, measures turbidity of the solution and assesses colour changes. So you are going from a tedious, variable process that doesn’t allow you to review the scientist’s findings, to an automated, highly reproducible process that stores an image of the analysis in our database. That can have a real impact on productivity and data integrity.
Why should a company spend huge amounts on robotics automation for high throughput activities?
The value of automation can be easily justified through the productivity gains provided by the systems. Scientists can eliminate tedious, time consuming tasks and focus on solving critical scientific challenges. This only scratches the surface of the real value these systems offer. By allowing scientists to generate a wide range of data quickly in drug development, organisations can build a deep understanding of the drug product and its behaviour that can have a meaningful benefit as the drug is moved through the development process. Furthermore, the data generated can be compared over long time periods, since all of the experiments are performed by a single automation platform and saved in a central database. The knowledge from this accumulated data can then be used to inform future experimentation and formulation designs. It is this build-up of organisational knowledge that leads to dramatic, and often unexpected, impact on productivity and innovation.
Presently, how many new systems and platforms are offered by Freeslate for cost effective HTR applications?
Freeslate has automation systems for small molecule solid form screening (preformulation), process chemistry and biologics formulation and formulation assessment. These specific systems are all based on two fundamental automation platforms offered by Freeslate.
The first is the Core Module 3 (CM3), our larger automation platform. This is a configurable system that allows for researchers to define a system that addresses their specific research need. Designed for chemical research, there are a range of capabilities available on the CM3 including pH measurement, heating, stirring, powder dispensing, viscous liquid dispensing and high pressure /high temperature reactors. The CM3 can also physically integrate with third party analytical instruments (UV/Vis plate reader, for example) and processing equipment (for e.g. centrifuge). The smaller automation platform is the CM Protégé. This system is designed for specific applications like powder dispensing, polymorph screening or biologics formulation assessment.
What are your plans for the Asian and Indian markets?
Pharma and biopharma are making significant investments in Asia and India at this time. This includes both regional companies, as well as investments from the US and European companies. We believe our products can help to maximise the benefit of these investments; therefore, we are taking a multi-pronged approach. First, we want to make sure scientists understand how our products might be able to help them. We have established distributors and agents in these regions that will help us raise awareness of our solutions. We have established reference labs in these regions including partnerships with Lupin Pharmaceuticals in India and Crystal Pharmatech in China. This allows interested scientists the opportunity to see the systems first hand. We have a global technical sales organisation that ensures we work with prospective customers to understand what their research need is and deliver a system that will have a meaningful impact on their productivity.
Secondly, we want to make sure our customers have a positive experience with our systems. We have established a global support organisation that is well-positioned to provide our customers with a positive user experience. Part of this is simply solving any issues that might come up with the system, but we see customer support as a step beyond this. We work with customers on software training, experimental design or whatever other help they might need to allow them to quickly get value from the systems. Since Freeslate has been active in high throughput research in these fields for nearly 15 years, we have built up expertise that we want to pass along to our customers.
How does a high throughput screening system contribute to a company’s success and how to exploit the system in the best manner?
Automation needs to be a tool that scientists are using to advance science. We find customers that have the most success understand how automation fits into an overall drug development strategy. There needs to be commitment from all relevant stakeholders on how the system will be utilised. Our software really fosters collaboration by allowing for experiments to be designed and shared among colleagues – even across different sites. Project teams can work together to define experimental parameters and really understand what data they need to reach a specific scientific decision. When talented scientists work together to use automation thoughtfully in a drug development process, it can have a dramatic impact on what they can achieve directly and how well they can support other parts of the development process.
Automation should also be a tool that builds knowledge in an organisation. Companies that take advantage of our centralised database and reporting tools to build knowledge – not just data sets – really see significant long term impacts to their productivity.
How important is the Indian market for Freeslate and what initiatives are being taken to support Indian customers?
The Indian market is a very important market for Freeslate. Pharma and biopharma companies are making significant investments in R&D in India, with spending increasing by more than 20 per year over year. Skytech is our channel partner in India who have significant market information and reach in life sciences segment. We want to make sure we are working with companies to help them get the most productivity and innovation out of these investments. We see this as a real opportunity for not only automation, but specifically for Freeslate. To support this we will be attending a number of conferences in India this year, sponsoring a meeting to raise awareness to the value of automation, and will be working with Lupin Pharmaceuticals as a reference lab. We’re pretty excited about the year we have planned.