PharmTech: What emerging technologies or practices do drug sponsors expect your organization to provide?
Ron Connolly: Sponsors expect CROs to lead implementation of technology and best practices that help them stay current with changing regulatory requirements. Within the past year, older elemental wet chemistry methods were replaced with ICP-MS and ICP-OES for USP monograph testing per the ICH Q3D revised requirements on specific quantification of heavy metals. Other growth areas (sponsors expect expertise, working practices, or instrumentation) are extractable/leachable testing, following new regulations on container closure; and in vitro release test (IVRT).
PharmTech: What scientific or technical advances have positively or negatively impacted drug development processes in this market segment?
Ron Connolly: Key advances in analytical testing:
PharmTech: Are you seeing shifts in demand for particular types of services? Please describe.
Ron Connolly: Demand for heavy metal testing, extractable/leachable testing, IVRT for all types of products, and purity/characterization analyses for large molecules have increased. Since large molecules are difficult to characterize using singular analytical techniques, a variety of test methods, from size exclusion chromatography, gel electrophoresis and Western Blot, to particle characterization using laser diffraction and fragmentation analysis using mass spectrometry may be employed. These challenges have increased demand for specialized analytical services.
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?
Ron Connolly: Common technical challenges often relate to instrumentation limitations. The use of currently available instrumentation generally involves sacrificing sensitivity for broad application, or vice versa. Most service providers actively attend relevant conferences and events, (such as Pittcon) and engage frequently with instrument developers to stay current on instrumentation technology and attempt to employ these technologies to specific analytical challenges.
PharmTech: What advances do you see in science or technology in this market segment in the next five years?
Ron Connolly: High throughput and sensitive analytical instrumentation will continue to advance. Using a combination of scientific expertise with the latest technologies will continue scientific advancement for analytical techniques. It is important for scientists to remain engaged in the development of new technology and ensure that the technologies developed are fit for the purpose they are intended.
PharmTech: What regulatory changes have positively or negatively impacted drug development/manufacturing processes in this market segment?
Ron Connolly: The implementation of Quality by Design (QbD) and its acceptance in the industry is creating the need for an updated approach in the drug development process. The increased work to understand the finished dosage form can be substantial depending on the product and manufacturing process. There has been a notable increase in the amount of sample analysis required to understand the process design space and critical quality attributes.
PharmTech: What changes are you observing in the organization and operations of drug sponsors in this market segment?
Ron Connolly: Many sponsors in the market segment of biosimilars are outsourcing most of the analytical work due to the need for trained chemists and equipment in order to perform testing to characterize molecules. As a specialized, high growth area, many sponsors do not have the capacity in house and look for organizations to guide them through the process.
PharmTech: Describe the role that quality agreements play in contract services relationships. How will FDA’s draft guidance on quality agreements affect the relationships between contract service providers and drug sponsors?
Ron Connolly: Although the guidance places ultimate accountability for compliance, quality, safety and efficacy with sponsors, contract facilities also assume responsibility for complicity, and run the risk of penalty for non-compliance. FDA establishes a quality agreement as a stand-alone and legally-binding contract for product liability and compliance. The contract facility and sponsor essentially assume joint responsibility, as active engagement from both parties is required. In turn, these relationships will be formally structured in terms of responsibility, deliverables and accountability.