PharmTech: What emerging technologies or practices do drug sponsors expect your organization to provide?
Mark Rogers: It is very important for a service provider to maintain existing technologies but also to keep up to date with developing equipment and methodologies. Mass spectrometry, for example, has evolved from a research tool to a technique that is often now expected in QC environments. Quality is perhaps the single most important aspect of all practices demanded by drug sponsors.
PharmTech: What scientific or technical advances have positively or negatively impacted drug development processes in this market segment?
Mark Rogers: Generally, the ability to automate analytical processes has made significant impact on precision and speed. A move towards UPLC technology allows for increases in the rate of analytical testing in the field of liquid chromatography although, due to the increased efficiency, such development can lead to an often unwanted re-evaluation of the product composition.
PharmTech: Are you seeing shifts in demand for particular types of services? Please describe.
Mark Rogers: In the specific area of biopharmaceutical testing, there has been an unmistakable expansion into services that allow higher order structures to be defined. Such techniques are now applied in characterization of primary products as well as for comparability studies such as in the testing of in biosimilars.
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?
Mark Rogers: One of the many technical challenges lies in definition of biotherapeutic impurities. Such studies often demand a multidisciplinary approach in terms of technology and expertise. SGS is able to respond to such requirements by maintaining a broad base of scientific experts and diversity within laboratory instrumentation which is continually updated.
PharmTech: What advances do you see in science or technology in this market segment in the next five years?
Mark Rogers: Traditionally, there has always been a demand for increased rate of testing and this will continue with advances in automation and application of technologies such as UPLC. In the biopharmaceutical testing field, advances in sensitivity and miniaturization will become critical, particularly with the evolution of individual patient therapies. Techniques such as FTIR may also advance to allow non-destructive, continuous screening which may find application in, for example, stability programs.
PharmTech: What changes are you observing in the organization and operations of drug sponsors in this market segment?
Mark Rogers: There has been a trend, particularly in the small/mid-size drug sponsors or those new to the biopharmaceutical market, towards a more consultation-type relationship with the service provider. Rather than simply asking for a pre-determined list of tests, service providers are now becoming much more involved in experimental design and assistance with regulatory issues.