Newsletter | February 17, 2014

02.17.14 -- Scaling Single Use Equipment; Tips For FDA Inspection

Bioresearch Online Newsletter
Departments:
Upstream Downstream Quality/Regulatory Supply Chain Integrity
» Featured Magazine Article
In Continuous Bioprocessing Wider Adoption Signals Industry Maturation
By Eric Langer, President and Managing Partner, BioPlan Associates, Inc.
Batch processing, both up- and downstream, has long been the dominant bioprocessing paradigm. Bioprocessing fluids are piped and transferred as a batch from one holding vessel or process equipment to the next. This finish-one-step-and- move-on-to-the-next approach works rather well, and advances over the years have resulted in a lot of experience and data. In fact, upstream and overall process yields have tended to double about every five years.
Featured Focus: Upstream
The Importance Of Scaling Single-Use Equipment
By Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC
Process equipment choices, whether multiuse or single-use, are commonly made early in the medicinal drug development activities, and in test labs, choices made in the test lab about which equipment would be tested is often dependent on either the availability of the equipment or knowledge about it. This often results in a legacy equipment choice. However, since the volumes used within the early drug development stages are very small, the process equipment used might not represent the process scale design, or even worse, is not scalable to process volumes. A proper plan and scalability investigation should precede the choice and testing of equipment, especially when being single-use.
ARTICLE: Improvements In Single-Use Bioprocess Product Testing
By Gregg A. Larson, Product Manager, Single-Use
Testing of single-use bioprocessing products is performed to mitigate risk for customers by validating that products will perform as intended and reducing the possibility they will damage or contaminate the biological materials processed through them.
APPLICATION NOTE: Removal Of Endotoxin From Monoclonal Antibodies
DATASHEET: Integrity PadReactor Mini Small-Scale, Single-Use, Stirred Bioreactor
By ATMI LifeSciences
POSTER: Investigation Of Cell Migration Using A High-Density Cell Exclusion Assay And Automated Microplate Imager
PRODUCT: Autoclavable Pipettes
PRODUCT: Sample Batching And Storage Boxes
» Downstream
WHITE PAPER: Process Review: Vero Cell-Based Vaccine Production
By K. John Morrow Jr., Ph.D., and Ma Sha Ph.D.
Viral diseases, including rabies and influenza, are worldwide challenges to the international biomedical community. WHO notes that in 1998 more than 32,000 deaths due to rabies were reported, while influenza has been responsible for millions of deaths worldwide over the course of the past century.
APPLICATION NOTE: How To Improve Isolation And Purification Of Natural Product Extracts
APPLICATION NOTE: Rapid Prototyping Solves Unique Bottle And Carboy Cap Situations, While Saving On Costs
APPLICATION NOTE: Global Biochemical Profiling For Bioprocess Optimization
DATASHEET: Bioburden And Fine Particle Reduction Filters
By 3M Purification
PRODUCT: Nuvia HR-S Chromatography Media: Strong Cation Exchanger
PRODUCT: HyPerforma Single-Use Mixer DS 300 Docking Station
» Quality/Regulatory
WHITE PAPER: Kinetic Analysis Of Antibodies From Different Cultured Media
By David Ho, Tom Fletcher, and Jessie H.T. Ni
The Octet QKe platform is evaluated to establish an analytical method for assessing the effects of media condition on the quality and activity of cultured antibodies.
WHITE PAPER: Achieving Automation Of Hygienic Production Processes
By Dipl.-Ing. Sebastian Kundel, Product Manager Process and Control Valves, Bürkert Fluid Control Systems
In the food and beverage industry, and also in the production of medicines and cosmetics, excellent hygiene in processes and around the plant plays a key role. This is ensured by stringent legislative regulations. Standards such as HACCP (Hazard Analysis and Critical Control Points) for food processing and GMP (Good Manufacturing Practice) for FDA-compliant processes in the pharmaceutical industry define extremely stringent requirements for cleanliness, safety, and product quality.
DATASHEET: Sequestosome 1 (SQSTM1)/A170 (Mouse)/p62 (Human)/ZIP (Rat) - Ubiquitin-Binding Protein
By Wako Laboratory Chemicals
BROCHURE: Amsco V-PRO 1 Plus Low-Temperature Sterilization System
BROCHURE: Production Freeze Drying 
PRODUCT: Wet Ink Roll Scanner
PRODUCT: Sanitary Series Couplings: Medical-Grade Polysulfone, 3/4" Mini And 1" Maxi
» Supply Chain Integrity
WHITE PAPER: Best Practices In Cold Chain Logistics Planning
By Dan Catizone, VP of Business Development, QuickSTAT
Planning is the key to successful and efficient Cold Chain Distribution. Yet even with careful planning, many companies still miss out on opportunities to save money, streamline processes, and increase overall efficiency.
WHITE PAPER: Tips On Preparing For An FDA Inspection: Are You Following cGMP?
By Bruce McDuffee, Marketing Manager, Vaisala Life Science Division
If you're in the business of manufacturing drugs, medical devices, nutraceuticals, or manufacturing or importing any product in the United States that must comply with current Good Manufacturing Practice (cGMP), your facility will be inspected by the U.S. Food and Drug Administration (FDA).
CASE STUDY: Good Teamwork And Communication Made A Valuable Pharmaceuticals Shipment From Toronto To Sydney Possible
BROCHURE: GxP Compliant Logistical Service For Pharmaceutical Industry
PRODUCT: Air Cargo Integrity: Real-Time Tracking
PRODUCT: PureTemp: Phase Change Materials (PCMs)
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Survey Shows Half Of Drug Companies Use Counter-Generics Teams
Upcoming Event
IBC's 2nd Annual Flexible Facilities conference brings together senior level executives and scientists from biopharmas, CMO's, 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, Save 20% off the standard rate with priority code FLEX14BRO. Download the event brochure
UPCOMING TRAINING

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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