IBC’s BioProcess International Conference and Exposition (BPI) is the largest bioprocessing event currently offered to our industry, bringing you new ideas, demystifying technology, and fostering partnerships in highly engaging formats to move drug candidates closer to approval. This year’s event will be held 26–29 October 2015 at the Hynes Convention Center in Boston, MA. BPI is engineered to be exactly what you need it to be. Formal and informal networking experiences connect you to peers, prospects, and customers. Parallel tracks…

What’s on the minds of groups involved in cell culture and fermentation in 2015? They’re looking to implement genomics and other “-omics” technologies in cell-line development and engineering. They’re working with new analytical tools to model, monitor, and control upstream production bioprocesses. Many are interested in the possibilities of perfusion and other continuous processes. They want the most sophisticated single-use options developed with modern bioprocessing in mind. They’re adapting cell culture knowledge to new product modalities and applying all this…

During the past decade, biomanufacturers have faced increasing bottlenecks, process times, and operation costs in their downstream processing. That has led many companies to reevaluate their traditional methods and technologies and consider replacing or supplementing them with strategies for reducing the number of purification steps and leveraging more efficient, less expensive, and well- understood approaches. Some strategies to enhance efficiency have focused on optimizing recovery and initial clarification processes, especially when removing host-cell proteins (HCPs). Although HCPs are an essential…

Biomanufacturers are striving for leaner and more flexible processing, and it’s paying off. Reports received at BPI are showing that companies are improving the efficiency and robustness of their processes, and some are making changes in facility and process designs. Multiproduct, closed-system, and “portable” manufacturing facilities are helping manufacturers meet capacity demands. And additional competition from biosimilars makers has pushed some companies toward further expanding their commercial market as their original biologics come off patent. Contract manufacturing in general is…

What’s on the minds of groups involved in drug-product manufacturing in 2015? They’re applying quality by design (QbD) principles and process analytical technology (PAT) to formulation and fill–finish. High- throughput and single-use technologies are helping them improve process economics as well as sterility and flexibility. Formulators are redrawing the lines between drug substance and drug product manufacturing, especially when it comes to preformulation analysis. Fill–finish groups are working out the details of new types of container– closures and delivery devices.…