Newsletter | February 24, 2014

02.24.14 -- Novartis Strengthens Cancer Research Program Through CoStim Acquisition; GSK, Teva, And More

Bioresearch Online Newsletter
Upstream Downstream Quality/Regulatory Supply Chain Integrity
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.
» From The Editor
A CDMO's Plan For The Future Of Biologics
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.
Featured Focus: Upstream
What Are The Current Drivers And Directions In Bioprocess Monitoring?
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.
GUEST COLUMN: The Advent Of Single-Use Technology: Moving Forward
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.
APPLICATION NOTE: Anaerobic Yeast Fermentation Using Redox Control
POSTERS: in vitro Microplate Assay That Monitors IL-6 Secretion And Cell Viability With Ovarian Cancer Cell Line
BROCHURE: Cryogenic Laboratory Vials
PRODUCT: Affinity Media: Ready-To-Use Media For Purification Of Biomolecules
PRODUCT: Single-Use Fluid Transfer And Storage
» Downstream
GUEST COLUMN: Dangerous Goods Classification: UN 3373 Biological Substance, Category B Confusion
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.
APPLICATION NOTE: Compound Profiling And Toxicity
APPLICATION NOTE: Automatic Detection Of Improper Test Setup Of A Filter Integrity System
BROCHURE: Enhanced Process Flexibility With Back-To-Back Insert Adapters
BROCHURE: Modular Disposable Heat Exchanger Brochure
SERVICE: Weekly Equipment Auctions From Major Bio And Pharma Manufacturers
PRODUCT: Fluid Control Systems For Downstream Processing
» Quality/Regulatory
WHITE PAPER: Streamlining Particle Count Data Management
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.
ARTICLE: The Demand For High-Flow Sterile Connectors For Single-Use
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.
ARTICLE: What To Know Before Initiating Product Packaging Changes For Gamma Processing
CATALOG: Auto-Readers And Biological Indicators For Steam
BROCHURE: Process Optimization And Scale-Up Of Freeze-Dry Products
PRODUCT: Eliminate Natural Killer Activity In Cells: Anti Asialo GM1 (Rabbit)
PRODUCT: Solvent Evaporators: HT Series
» Supply Chain Integrity
WHITE PAPER: Supply Chain Reacts To Healthcare Cost Pressures With Innovative Partnerships
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.
ARTICLE: Growing Freight Tonnage Equals Growing Cargo Security Concerns
DATASHEET: Accurate Temperature-Sensitive Shipment Protection: Envirotainer RKN t2
By Envirotainer
DATASHEET: Thermal Pallet Shipper: CSafe RKN
By CSafe Global
» Most Recent News
Novartis Expands Cancer Immunotherapy Research Program
GSK Begins Phase III Trial To Evaluate Rare Disease Drug Mepolizumab
Teva Wins FDA Approval For Synribo Injection
Daiichi Sankyo And UMN Pharma To Link Up On Norovirus Vaccine
Global Vision Releases Proofware The First All-In-One, Cloud-Based, Packaging Inspection Suite
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.

New registrations can save 20 percent off the standard rate with priority code FLEX14BRO. Download the event brochure

Monitoring Electronic Health Records (EHRs): Frequently Asked Questions
Date: Thursday, February 27, 2014 • Time: 1pm – 2:30pm EST

Writing Clinical Monitoring Reports: Using the Liquid Report Writing Method
Date: Friday, February 28, 2014 • Time: 1pm – 2:30pm EST
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