Bringing new drugs and other treatments to the market poses many challenges to pharmaceutical developers and their partners. In this interview, Betsy Baer, senior director, Americas Contract Organizations Business, Waters Corporation, discusses which stages of drug development tend to be most challenging, some of the services and technologies that can help meet these challenges, the importance of collaboration, and key trends in the industry.
Q: Which stages of the drug discovery/development/production process tend to be most challenging? Why?
A: All of the stages carry with them their own challenges. From an analytical perspective, the development and production aspects are often the most challenging, as efficiency, safety, compliance, quality, continuous supply, consistency, and scalability (including validation at other sites) all become so critical in bringing drugs to market, and ultimately to patients.
Q: What are some of the key solutions to those challenges?
A: Key solutions include automated analytical technologies such as liquid chromatography and mass spectrometry to assess content, with the ability to measure and characterize analytes of interest to ensure quality, safety, efficacy, and consistency. Training is critical, and something that has to be well thought out as a key investment and requirement. The job market is very robust at this time and turnover is an ongoing concern, so including multiple employees in training sessions is extremely important. This includes hands-on training and best practices for utilizing/maintaining technologies and software.
Automation is key to efficiency and productivity, and there are many solutions to address this including robots for sample prep and sample handling, multiplexing, PAT and on-line/at-line monitoring, and especially results management to efficiently and effectively aggregate and re-purpose data to enable quick decisions. Service and proactive instrument maintenance to maximize uptime are key to success, as downtime can be very costly and meeting deadlines is always of critical importance. New technologies, including novel materials of construction designed for the separation of complex molecules and biologics, add value and save time in the methods development process. Mass spectrometry designed to analyze biologics in a regulated environment is becoming much more prevalent as a QC tool, especially as it pertains to well-characterized biopharmaceuticals.
Q: What lessons have you learned from helping your customers solve their challenges?
A: Collaboration with a capital C! Sharing our knowledge and insights is so important, including all the lessons learned from the pharma industry and our own subject matter experts. We collaborate very closely through on-site evaluations, scientific projects, early access to technology and many workshops to seek the voice of the customer to integrate into our future products and product enhancements. The pandemic has brought about a whole new level of cooperation and agility among pharmaceutical companies, CDMOs and suppliers, and we have participated in several projects where the CDMOs, their sponsors, and our company have worked together to accelerate a solution and product delivery. Outsourcing became a critical need for vaccine and therapeutic development and production during the pandemic, and the CDMOs were well prepared to address this need in terms of both capacity and expertise.
Q: What main trends do you expect to see in drug discovery and development going forward?
A: One of the key trends most recently has been a focus on data security, data integrity, and compliance. Cyberattacks are a new reality, and with multiple projects and multiple clients, data security and data protection/privacy present a new challenge. As a supplier, it’s a high priority for us to constantly assess and address this through our software platforms and data interface portfolio to focus our efforts not only toward compliance and data integrity requirements, but also data security and business continuity.
There is also tremendous growth in biologics and new modalities (cell and gene therapy, vaccines, biotherapeutics such as mAbs, bsAbs, ADCs, and mRNA-based therapies) and more complex molecules and formulations. With an increase in parenteral drugs and vaccines, the need for impurity analysis and measuring E&L (extractables and leachables) becomes even more important, so we are seeing an increase in the need for mass spectrometry for low level quantification, as well as characterization.
We are also seeing an ongoing trend toward onshoring, where the pandemic has highlighted the need to reduce dependency on other countries such as India and China for APIs and raw materials, so there is a renewed focus on building capabilities to ensure continued supply and the ability to manufacture locally. CDMOs have played a critical role in building the capacity to meet these increased demands, with new innovative methodologies along the way. The federal government and academic institutes will continue to play a key role in supporting scientific innovation and key collaborations. We have all become much more agile during the past 18 months in response to the urgency of the pandemic and the role of science and technology. CDMO partners have been key to accelerating these efforts and we foresee continued growth for outsourcing partners in pharma, especially for biologics, manufacturing, and end-to-end services.