If you work with powders or other bulk solids and are interested in learning how to design bulk solid handling systems, this workshop is for you! Systems for handling powders and other bulk solids are often improperly designed, leading to: Erratic flow, no flow or limited throughputs Poor product quality and excessive downtime Customer complaints Safety issues including […]

Single use technology opens up a world of possibilities never considered before for biotech/pharma manufacturing but also brings with it a host of new challenges. As companies move from simple application of single use systems like bags (for buffer storage) to more complex single use systems and even entire single use facilities, the potential impact […]

Sampling of pharmaceutical water is a required activity that has historically relied on the expertise of those responsible for developing and implementing the sampling procedures and/or plan. Sampling provides proof that a system producing water for pharmaceutical applications is operating under control and that the water being used is of suitable quality for the intended […]

The call for implementing continuous processing in the manufacturing of bio-pharmaceuticals requires re-thinking of process chromatography and its equipment design. Proof-of-concepts of innovative multi-column continuous processes were introduced by the industry, which verified improvements in resin utilization and increased productivity [1]. Now, these concepts are transferred and verified at the pilot and production scale. First […]

For those who have an interest in pharmaceutical waters, the recently released USP 39 Supplement 2 includes an updated Informational Chapter <1231>. This new and improved chapter has been rewritten and reorganized including a new table of contents, added hyperlinks for contemporization and ease of use, clear and concise technical explanations, and additional material including […]

Industry leaders Bert Frohlich, Director of Strategy and Technology Lifecycle, Shire, and Amy Lachapelle, Lead Consultant & Founder, QbD Strategies, presented “Quality by Design” as part of the Chapter’s recent Regulatory Symposium held at Northeastern University. Well known in the regulatory field with a combined 38+ years of experience in biopharmaceutical manufacturing, the speakers presented […]