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18 Pharmaceutical Technology Europe BIO/PHARMA OUTSOURCING INNOVATION eBOOK 2022 P h a r mTe c h . c o m Development A ccording to market research, the size of the outsourcing sector serving the pharmaceutical and biotechnology industries is expected to ex- pand, reaching $99.4 billion by 2028 (1). Demand for outsourced services is being driven by several factors, such as high demand for biologics and small molecules, a lack of in-house expertise, and rising costs associated with in-house development capabilities. To find out more about how demands have changed for outsourcing partners providing method development ser- vices and the trends affecting this sector, Pharmaceutical Technology Europe spoke with Jerry "Jr." Mizell, senior di- rector, Analytical Services, Metrics Contract Services. Changing demands PTE: Could you provide a brief overview of how the demands have changed over the years for outsourcing partners in terms of method development services? Mizell (Metric s Contrac t Ser vices): Nowadays, there is an increased demand for sound methods to be developed early in t he product life c ycle. More customers wa nt rugged and robust methods in place as early in the devel- opment process as possible, and they want methods that require minimal changes as their programmes advance to commercial phases. Based on the experience of Metrics Contract Services, customers a lso want to develop qua lit y control (QC)- friendly methods that help maximize laboratory efficiency in the commercial phase. Across various methods developed in recent years, dissolution, in particular, has been in the spotlight. A comprehensive approach to dissolution should produce a discriminating method that can demonstrate that an adequate drug product has been manufactured. Current customer expectations also demand a detailed dissolution method development report describing how the dissolution procedure was derived. This is especially important for new drug applications (NDAs). ANDRII YAL ANSKYI - STOCK.ADOBE.COM Method Development in Demand Felicity Thomas Experience is an invaluable asset for outsourcing partners, particularly as more challenging method development services are in demand.