Abstract
The market for therapeutic proteins is on the rise, plagued by several challenges related to production amounts and costs. Solutions to these problems are widely thought to come from academia, governments and production companies. This conference aimed to bring experts in the industry together under one roof, in order to demystify several novel technologies in therapeutic protein development. Key topics included analytical tools for protein stability and ligand interactions, measurement of protein aggregates as small as 30 nm and reducing production costs, just to name a few. The need to eliminate protein aggregates early during bioprocessing was emphasized. Finally, several companies presented novel technologies related to therapeutic protein development.
It is estimated that the global market for therapeutic proteins will grow to more than US$150 billion by 2013, with the USA and Europe playing significant roles. The dire need to meet vast market demands requires collaboration between governments, academic institutions and industry. Such collaborative approaches facilitate opportunities to discuss the challenges facing key sectors of therapeutic protein development and demystifying some of the novel approaches and new technologies that are currently being developed. That was the aim of the second annual Therapeutic Protein Production Event, which brought together more than 40 delegates to discuss various issues related to protein production. Several presentations on advances in therapeutic protein development were delivered and a panel of experts with broad backgrounds gave comprehensive answers to critical questions during a trouble-shooting panel session.
Paul Dalby (University College London, UK) described a recently developed microfluidics-based biophysical analytical tool for protein stability and ligand interactions. The importance of rapidly analyzing proteins under preformulation, stress and bioprocess conditions was emphasized. He also introduced an automatable high-throughput method for measuring protein stability, tolerance to freeze-drying, solubility, aggregation and precipitation. All of these approaches are valuable in permitting rapid screening of proteins for manufacturability and would reduce bioprocess development time and costs.
Protein aggregation occurs during most steps in therapeutic protein processing, limiting overall yields and is capable of triggering an immunogenic response in a patient. As a result, proper characterization of protein aggregates is important in protein production. Patrick Hole (NanoSight, Amesbury, UK) illustrated a technique that detects and measures aggregates down to 30 nm. The unique technology also allows for visualization of light scattered from viruses/bacteriophage in liquid suspension. The system equips the user with the ability to accurately determine size as well as number of viruses and aggregated particles. Compared with frequently used techniques, such as dynamic light scattering, the NanoSight technique yields high-resolution data, and is easy to use, rapid and inexpensive.
As is the case with any process, the final cost of products is expected to be as low as possible in order to be competitive in the market. Methods of reducing therapeutic protein production costs were discussed. Andrew Brown (BioPharm Services, Chesham, UK) emphasized the need to use economic modeling tools in assessing manufacturing costs and sensitivity of financial returns to changes in the projected market demand throughout biopharmaceutical development cycles. These models enable better business decisions to be reached early in process development since they provide critical evaluation of alternatives involved in the process.
This event was chaired by Brendan Fish (NPI-PT Director at GlaxoSmithKline, Barnard Castle, UK). Other speakers included Gareth Lewis of MedImmune (Cambridge, UK): ‘Scale-down approaches to CHO clone selection and process development facilitating high-level mAb expression’; Phillip Mellors (Eden Biodesign, Liverpool, UK): ‘Bioprocess characteristics using quality by design principles’; Tony Hitchcock (RecipharmCobra Biologics, UK): ‘Disposable technologies’; Stuart Hassard (DeltaDOT Ltd, London, UK): ‘Using novel high performance capillary electrophoresis approach in all stages of the bioprocess’; Simon Webster (Avacta, Wetherby, UK): ‘New proteins, new problems: analytical clues to the stability of therapeutic proteins outside the lab’; and Hanna Jankevics (Malvern Instruments, Malvern, UK): ‘Using light scattering to predict protein formulation stability and detect the early onset of aggregation’.
At the end of the day, delegates were satisfied with ongoing developments in therapeutic protein production. Several challenges and possible solutions were discussed, with an emphasis on limiting costs of production and eliminating protein aggregates early in bioprocessing. The event was also an opportunity for several companies to showcase novel technologies related to therapeutic protein development. NanoSight presented a new direct visualization, sizing and counting system for protein aggregates; Innova Biosciences advertised its easy-to-use antibody labeling kits; PAA Laboratories Ltd introduced ActiCHO as the next-generation media system for CHO-DG44 cells; DeltaDOT Ltd presented an integrated label-free analytical process technology; and Broadley-James and Malvern Instruments introduced a host of products.
This meeting was organized by Euroscicon, and the next Therapeutic Protein Production Event will take place on 14 June 2012.
Financial & competing interests disclosure
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.