Biologics drug development and manufacturing
PharmTech: What emerging technologies or practices do drug sponsors expect your organization to provide?
John Sandles: For mammalian cell culture there is an increasing demand for single-use technologies and is expected as the norm in this sector. The environmental and financial outcomes are favorable over stainless steel at smaller scales of production, however at larger scale stainless steel is still a very prominent option. Using single-use means up to 90% less water is needed for cleaning purposes per batch, meaning a reduced contamination risk and cost is incurred against stainless steel.
PharmTech: What scientific or technical advances have positively or negatively impacted drug development processes in this market segment?
John Sandles: The introduction of High Throughput Screening technologies across R&D means that it is much easier to demonstrate rapid and scalable process development. For instance our recently purchased ambr250 aids in rapid selection of upstream fermentation conditions. This initial screening timeframe reduction takes process development further off the critical path to in human trials and consequently means the drug development process is reduced with an increased data set to justify forward working decisions and satisfy regulation.
PharmTech: Are you seeing shifts in demand for particular types of services? Please describe.
John Sandles: We continue to see a range of projects with customers requiring a mix of services from process development, analytical, and GMP manufacturing.
PharmTech: What pressing technical challenges have you seen in this market segment? What actions has your company taken to resolve the challenge? What actions does your company suggest?
John Sandles: We are finding that customers are expecting material that represents scalability to be produced at much faster rates. Fujifilm has the technology to meet these demands with both microbial and mammalian cell culture expression systems. Our industry leading pAVEway microbial technology allows high titer proof-of-concept studies in four to six weeks. We have added extra HTS capability for upstream and downstream process development to further reduce time to clinic for our customers.
PharmTech: What advances do you see in science or technology in this market segment in the next five years?
John Sandles: We expect to see more and wider deployment of single-use technology as the benefits become widely recognized.
PharmTech: What regulatory changes have positively or negatively impacted drug development/manufacturing processes in this market segment?
John Sandles: The definition of a regulatory pathway for biosimilars in the US is a significant event, we are watching closely to see how this spurs biosimilar development for the US market.
PharmTech: What business trends have positively or negatively impacted drug development/ manufacturing processes in this market segment?
John Sandles: The flow of investment, primarily from a very strong series of IPOs in the US market during 2013, has been welcome and has helped a number of our customers to progress lead drugs through the clinic.
PharmTech: What changes are you observing in the organization and operations of drug sponsors in this market segment?
John Sandles: Since 2008, both preclinical and clinical pipelines for biotechnology and pharmaceutical companies have shrunk. Indeed the %CAGR for R&D spend between 09-13 was 1.2% whereas between 06-08 it was 9.3%. Our own data suggests that biologics are still significant in clinical pipelines and are regarded as attractive development candidates. In addition, drug approval rates are being maintained signaling a strong pipeline is still flowing.
PharmTech: How has quality by design influenced a drug sponsor’s expectations of suppliers?
John Sandles: QbD has been used for years at the company and we generally find it customer specific whether or not QbD awareness is apparent. Pharma and large biotech tend to expect this as standard, but small/medium biotech may be less aware of the advantages, we would encourage them to select a CDMO which offers QbD as standard as this will make the process more scalable and commercially attractive.