IBC's Biopharmaceutical Development & Production (BDP) Week event (March 24 to 27, 2014, San Diego, CA) provides the most in-depth coverage of bioprocessing methods in the field, to give you the tools you need to develop and manufacture the increasingly diverse and complex molecules emerging in the biopharmaceutical pipeline. New registrations can save 20 percent off the standard rate with priority code BDP14BRO. Download the event brochure.
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
When narrowing the field of potential manufacturing partners, finding one that is flexible enough to respond to increased production requirements in an ever-changing industry is imperative. After all, that is the reason many outsource in the first place. Peter Soelkner, managing director of Vetter, believes being flexible is not just the ability to respond to a client's current needs, but also being prepared to meet their future needs.
By William Whitford, Thermo Fisher Scientific What are the issues in bioprocessing monitoring? Accurate, timely, and nonperturbing monitoring of bioprocesses has always been of interest. Drivers of this begin from the need to know as much as possible about the state of the cultured cells, their environment, or the process during development and optimization. PAT-inspired process monitoring also provides increased process understanding in development, and better control in manufacturing. A number of both classic and brand-new needs demand that we better understand what's going on within the bioreactor. Concerns in bioprocess monitoring begin with all the standard issues of accuracy, precision, and linearity. But, current bioprocessing quality initiatives and process developments are presenting additional demands.
By Mario Philips, Senior Vice President and General Manager at ATMI LifeSciences
For more than three decades, novel biologics, including monoclonal antibodies, immunotherapies, vaccines, and therapeutic proteins, have transformed the pharmaceutical and therapeutic landscapes. Yet as patent expirations on many of these biological blockbusters come to fruition, there is significant competition coming from biosimilars; this is expected to continue leading into 2020. The resulting increases in demand for more specialized drug products — including vaccines and cell therapies — in the development pipeline has drastically spiked demand for manufacturing capacity.
By Michael Gotz, QuickSTAT
In the previous blog post "Infectious Biologicals Category A and B — Classification Guidelines," I provided definitions of infectious biologicals in category A and B, and some basic guidelines on how to classify your shipments. These definitions are clear and helpful when you know that your shipment contains pathogens. In that case, it is either on the list for Category A, or if it is not, then it is classified as Category B.
By Paul Yates, Beckman Coulter Life Sciences
Pharmaceutical cleanrooms have gone through drastic changes in recent years as mergers, acquisitions, facility closures, drug patent-cliffs, and other industry dynamics have forced manufacturing facilities to continually adapt to remain both competitive and compliant with U.S. Food and Drug Administration (FDA) regulations.
By Brent Bushnell, Colder Products Company
When the first sterile connectors were launched in the early 2000s, single-use systems and bioreactors where focused on small-scale production at the lower end of pilot-plant range. Maximum single-use bioreactors ranged from 200 L to 500 L, and although sterile hold bags of 1,000 L to 2,000L were used, flow rates of 20 L per minute were sufficient in most cases. Sterile connectors designed around 1/2" I.D. formats performed well for the majority of single-use applications at that time.
By Dave Bode, VP, Health Care Solutions – DSC Logistics
Innovation defines a wide range of initiatives that supply chain leaders in life sciences companies are pursuing to best help their organizations meet the fundamental changes occurring in the industry: heightened regulatory enforcement, outcomes-based reimbursement, consumer-centric vs. provider-centric care, increased access to care, and new taxes. The magnitude of these changes was made perfectly clear at a healthcare conference hosted by Gartner in November 2012. The keynote speaker, Don Cassey, CEO, Medical Segment, Cardinal Health, declared that the healthcare industry must reduce its costs by 30 percent in order to remain sustainable. To put this in perspective, this means that the U.S. healthcare system would need to shed $5 Trillion in operating cost. The need and value of step-change innovation in the healthcare industry will never be higher.
IBC's 2nd Annual Flexible Facilities conference brings together senior level executives and scientists from biopharmas, CMOs, technology providers, engineering firms, and regulatory groups to explore the changing landscape of biologics manufacturing and to share case studies of the latest flexible facility implementations, lessons learned, and practical experiences.