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In the fast-moving world of biopharmaceutical research, where scientists are trying not only to solve today’s analytical problems, but also to guess what’s around the next corner, the traditional models for accessing cutting-edge analytical technology no longer deliver. Much of the challenge lies in anticipating the unknowns in a field where the pace of development is unprecedented and analytical and regulatory requirements continually evolve. For those in biopharma’s frontline—i.e. working in candidate screening, where analytical testing has been cited as one of the major bottlenecks—new problem-solving technologies cannot come too soon.
A significant hurdle for analytical instruments companies in providing solutions to these ever-changing problems is to recognize that they can’t answer these questions along, and to facilitate a collaborative approach. The Bioscience Development Initiative (BDI) at Malvern Instruments provides a partnering vehicle through which biopharmaceutical companies can embed themselves in the development process, as well as a nimble approach to technology development that circumvents the traditional, route to providing a new analytical tool. The shared learning that such partnering generates enables all parties to understand and anticipate the analytical needs of the biopharmaceutical industry and to steer an effective path to rapidly identifying and applying emerging technologies to maximum effect.
The analytical challenge
With the advent of biopharmaceuticals has come a paradigm shift in the development, manufacture, storage, testing, and delivery of medicines. These protein-based therapeutics are grown, not made, and then delivered intravenously rather than in traditional solid dosage forms. Major developments are taking place within a constantly evolving regulatory environment as the industry comes to terms with new product quality issues and product quality attributes. Given the very high cost of developing biological molecules there is an imperative to root out potential “problem children” early, progressing only those with the highest chances of success as manufacturable, efficacious, safe, and profitable products.
In small-molecule drugs, the key attributes of purity and potency are established, measured, and controlled using well-proven analytical techniques. Defining purity and potency for proteins that are harvested from biological cells, and which themselves can be a source of contamination through aggregation, misfolding, or denaturation, is much less straightforward. Consequently the analytical technology needed to address quality assurance and quality control requirements, as well as to deliver the biophysical and biochemical data essential in pre-formulation and formulation, is wholly different from the pharmaceutical industry’s historical norm.
Selecting the best candidate molecules immediately post-discovery, for example, involves a number of physicochemical testing processes designed to eliminate molecules that might throw up formulation, delivery, or manufacturing problems far downstream. Viscosity or the physical and chemical stability of the formulation can be deciding factors in whether a molecule attracts further interest and investment, but at this stage only very small volumes are available on which to perform a whole battery of testing. The analytical tools to effectively address these issues are only just beginning to emerge.
Advantages of partnering
The goal in partnering with industry players is to encourage mutually beneficial information sharing and an understanding of what the problems are and how they can be solved. The Bioscience Development Initiative works both with those in biopharma—where the analytical needs lie—and with those who lead analytical technology development. BDI reaches out to universities, small start-ups, and long-established companies in search of promising new technologies, Its focus is on the biotechnology sector, in particular the biochemical and biophysical characterization needs of formulation and product development within biopharmaceutical companies.
The companies who enter the partnership help drive the development of new analytical tools and gain early access to (often embryonic) technologies and help shape their future development and application. BDI will fast-track those that show promise, advancing them quickly towards becoming viable tools to help relieve analytical bottlenecks, speed up development, and support an accelerated time to market. Equally, the iterative learning at the heart of this process enables a “fail fast” approach, sidelining those technologies unlikely to deliver value for either the biopharmaceutical industry or Malvern.
As the process of developing biopharmaceuticals matures, new approaches to providing critical analytical measurements are needed. Early biopharmaceutical partners to Malvern’s Bioscience Development Initiative feel that the program is providing a low-risk opportunity for them to test out novel ideas and play an integral part in a development process designed to rapidly deliver the analytical technologies they need to get new products to market.
About the author
Dr. Lewis received his PhD in chemistry from the Polytechnic of Wales and did his postdoctoral fellowship at the National Institutes of Health. After the sale of Spectral Dimensions to Malvern Instruments he was appointed to Malvern’s Board of Directors and holds the position of chief technology officer.
Filed Under: Drug Discovery
