Newsletter | May 5, 2014

05.05.14 -- FDA Publishes Final Guidance On Orphan mAB Sameness

Bioresearch Online Newsletter
» Featured Poster
Challenges In Biosimilar Monoclonal Antibody Cell Culture Process Development: Media Optimization Is A Key To Success
By Erin Yeh and Qinghai Zhao (Purification Group), Joseph Bordas-Nagy (Protein Characterization Group), Ping Feng (Analytical Group), TEVA Biopharmaceuticals
Biosimilar, a term synonymous to "follow-on biologic," requires very stringent and high standards of comparability with the original biologic drug that is being replicated. Unlike conventional small molecules and chemical generics, "biogenerics," or biosimilars, especially monoclonal antibodies, have complex structures and functions that are affected by slight changes in the manufacturing process.
Featured Focus: Quality/Regulatory
Save Time And Improve Data Integrity: Cleanroom Environmental Monitoring
By Tony Harrison, UK Subject Matter Expert to ISO Technical Committee 209 Working Group
The intensely manual practices of cleanroom classification and routine monitoring are time-consuming and prone to data errors. Particle counter performance and accuracy can vary widely, leading to inaccurate particle counting data.
WHITE PAPER: Freeze-Drying Generics: Cost Advantages And Considerations
By Dr. Kevin Ward, Biopharma Technology Limited
The FDA defines a generic drug as "a drug product that is comparable to a brand-listed drug product in dosage form, strength, route of administration, quality and performance characteristics and intended use."
APPLICATION NOTE: Process Optimization Made Easy: Design Of Experiments With A Multibioreactor System
BROCHURE: Increase Packaging Accuracy: ArtProof Artwork Inspection
BROCHURE: Arc Sensors Are Fully Compensated, Backwards Compatible Measurement Signals
» Supply Chain Integrity
WHITE PAPER: A Challenge For Supply Chain Performance Is The Complexity
CASE STUDY: When Failure Is Not An Option In The Supply Chain
DATASHEET: Accurate Temperature-Sensitive Shipment Protection: Envirotainer RKN t2
By Envirotainer
PRODUCT: ViewLinc Continuous Monitoring System (CMS): Monitoring, Alarming, And Reporting Software
» Downstream
APPLICATION NOTE: Best Practices For Process-Scale Column Packing Of CHT Ceramic Hydroxyapatite Media
DATASHEET: AseptiQuik STC Connectors
By Colder Products Company
BROCHURE: DASware Migrate Software: Integrate Different Bioreactor Control Units
CATALOG: Chromatography Media Selection Guide
PRODUCT: Single-Use Heat Transfer
PRODUCT: Reveleris X2 Flash Chromatography System: The Next Generation In Innovation
» Upstream
APPLICATION NOTE: Automated Cell Dispensing And Image-Based Spheroid Formation Tracking
By Brad Larson and Peter Banks, Applications Department, BioTek Instruments, Inc.; and Nicky Slawny, 3D Biomatrix, Inc.
Scientists using cell cultures for drug discovery, toxicology, stem cell biology, and basic research realize the critical importance of 3-dimensional (3D) models. Data from cells cultured in a nonphysiologic, monolayer format on plastic surfaces has long been suspected to differ from true in vivo physiology, and there is mounting evidence that this difference is slowing the pace of scientific discovery.
APPLICATION NOTE: HarvestClear Filtration System For Harvest Of Small-Scale Bioreactors
DATASHEET: Bioburden And Fine Particle Reduction Filters: LifeAssure PNA Series
By 3M Purification
DATASHEET: Sentino Filter Dispenser
By Pall Life Sciences - BioPharmaceuticals
BROCHURE: BioBLU Single-Use Vessel Adaptor Kits
APPLICATION NOTE: High-Throughput Screening And Process Development For Capture Of Recombinant Pro-Insulin From E. coli
» Most Recent News
FDA Publishes Final Guidance On Orphan mAB Sameness
MorphoSys And Temple University To Collaborate In Antibody Discovery
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Agenus To Collaborate With Merck For Cancer Immunotherapies
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Gain the insight and contacts you need to make your single-use platforms more efficient, economical, and meet more complex drug demands at IBC's 11th Single-Use Applications for Biopharmaceutical Manufacturing conference, taking place June 9 and 10, 2014, in Boston, MA.
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UPCOMING TRAINING

Introduction To Biostatistics: Collecting And Summarizing Data
Date: Wednesday, May 14, 2014 • Time: 1pm – 2:30pm EST
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