In literature and music, a keynote establishes the main underlying theme of a work of art. Think of the famous “da-da-da-DUM” in Beethoven’s 5th Symphony. Or in George Orwell’s Animal Farm: “All animals are equal, but some animals are more equal than others.” Similarly, a keynote address establishes the framework for program of events or convention agenda. Frequently the keynote speaker sets the underlying tone and summarizes the core message or most important revelation of an event. Some famous keynote…

  What’s on the minds of groups involved in cell culture and fermentation in 2014? They want to build on recent achievements in reducing timelines and cost-of-goods (CoGs) while increasing efficiency and productivity by implementing potentially disruptive approaches and technologies. Those include genomic tools and synthetic biology, continuous bioprocessing, single-use applications, process intensification, raw-material integrity test methods, culture media optimization approaches, technology transfer, and small-scale models. Raw Materials Matter: Culture media, supplements, and related ingredients are important raw materials in…

  What’s on the minds of groups involved with downstream processing in 2014? They want to capitalize on innovations in methodologies, materials science, and technologies to help optimize efficiencies. They’re using process design and flexibility in downstream processing to purify an emerging wave of antibodies and novel product modalities. They’re interested in disruptive harvest-step technologies, new chromatography chemistries, continuous processing and the interface between upstream and downstream, high-throughput technologies and modeling, sequence variant analysis, and improving flexibility and facility fit.…

What’s on the minds of leaders involved in manufacturing and operations strategy in 2014? They want to maximize efficiencies and cost savings across their manufacturing networks by implementing potentially disruptive technologies, operational excellence and new facility concepts. But they also have to be flexible to the production needs of diverse pipelines in a multiproduct environment. New concepts in biomanufacturing can help companies reach those goals through technology transfer, scale-up/scale-down, continuous manufacturing, single-use applications, and possibly relaxing some biomanufacturing facility environmental…

What’s on the minds of analytical and quality laboratories in 2014? They want to stay abreast of both emerging analytical tools for biotherapeutics and increasing quality expectations. They need to optimize their analytical strategies and reduce quality risk across every product’s life cycle. They’re focusing on physiochemical characterization methods, impurities and product variants, biosimilars and complex glycoproteins, high-throughput methods for predicting stability and developability of early stage products — and of course, quality risk management. Characterization, Structure, and Function: As…

What’s on the minds of biopharmaceutical formulators in 2014? They want to apply innovative technologies and phase-appropriate strategies for preformulation and formulation development of monoclonal antibodies (MAbs), next-generation biologics, non-MAb protein therapeutics, vaccines, biologics, and other product modalities. They need to be aware of the latest drug delivery options. High-throughput analytical methods are helping in preformulation and liability assessments. Stability testing and physiochemical characterization remain key. Product Characterization: As is often the case, analytical and formulation laboratories have a lot…