Strategic Approaches to Process Optimization and Scale-up - Almac

devised. Rather than completing each experiment at the full scale, the experiment can be performed using a suitablysized aliquot of the blend manufactured already. As both dry granulation and compression are a continuous throughputprocess, the parameters investigated are mainly independent of batch size used. Using this approach, a 60-kg blendcould be divided into 3-kg sublots, allowing up to 20 experiments to be run.Following completion of the experiments and analysis of the data, a confirmatory batch could be manufactured using theoptimized parameters determined from statistical analysis and preparation of a design space. The resulting batch or tabletcores could be progressed to coating if required. Again, the coating process can be investigated using method 1 or 2.ConclusionStrategies for product development can vary from company to company and from product to product, and as such, acontract development and manufacturing organization (CDMO) must be able to provide a service that can suit therequirements of any customer. For a variety of reasons, a company might choose either an empirical approach or a moresystematic approach to product development. The approaches described can aid in the provision of a high-qualitydevelopment offering from the outset while striving to control timelines and costs, which are commonly seen as opposingforces in the pharmaceutical industry.Conor P. Long* is a senior formulation development scientist and John McQuaid is a technical development manager,both at Almac Pharma Services, 22 Seagoe Industrial Estate, Craigavon, BT63 5QD, UK, tel: +44 (0) 2838 363363, fax+44 (0) 2838 363300, conor.long@almacgroup.com.*To whom all correspondence should be addressed.References1. ICH, Q1A (R2) Stability Testing of New Drug Substances and Products, (ICH, Geneva, Feb. 2003).2. EMA, Note for guidance, Process Validation, CPMP/QWP/848/96, (EMA, London, Sept. 2001).3. ICH, Q8 (R2) Pharmaceutical Development, (ICH, Geneva, Aug, 2009).Pharmaceutical Tech ‐ Sep 10 ‐ Process Opt & Scale‐Up