Newsletter | January 13, 2014

01.13.14 -- An Inexact Science: Biosafety Risk Assessment

Bioresearch Online Newsletter
Upstream Quality/Regulatory Supply Chain Integrity Downstream
» Featured Guest Column
Despite Challenging Economic Environment, Biotechs Are Booming
By Aftab Jamil and Ryan Starkes

CRO Oversight: Risk Assessment And Action Planning
Date: Tuesday, January 28, 2014 • Time: 1pm – 2:30pm EST

Data Integrity And Manufacturing: Detecting And Mitigating Risk
Date: Wednesday, February 12, 2014 • Time: 1pm – 2:30pm EST

Quality By Design (QbD) In Clinical Trials: Build Bullet-Proof Protocols
Date: Tuesday, February 18, 2014 • Time: 1pm – 2:30pm EST
Featured Focus: Upstream
APPLICATION NOTE: How To Analyze Nuclear Stained Cells Using A Multimode Microplate Reader With DAPI-Stained Cells
By Paul Held Ph.D. and Peter Banks, Ph.D., BioTek Instruments, Inc.
The imaging and analysis of fluorescently stained cells has traditionally been accomplished using manual microscopic methods with low numbers of samples, while the analysis of higher sample numbers requires the use of very expensive dedicated microscopes.
APPLICATION NOTE: Successfully Cultivate Hybridoma Cells In A Fibra-Cel Packed-Bed Basket
APPLICATION NOTE: Increase Enzyme Stability In Chiral Production With Purification And Immobilization
POSTER: A Single, Chemically Defined Culture Medium Supporting A Wide Range Of Development Activities For The Production Of Biologics
By Mark C. Arjona, Catherine Nguyen, Jenny Y. Bang, Tom Fletcher, and Jessie H.T. Ni
In the production of biologics, various development activities require different medium requirements, calling for multiple media. 
BROCHURE: Filter Systems For Pharmaceutical Separations 
BROCHURE: Pall XRS 20 Single-Use Bioreactor System 
VIDEO: Measure DNA, RNA, Or Protein In Seconds: NanoDrop 8000
» Quality/Regulatory
WHITE PAPER: An Inexact Science: Biosafety Risk Assessment
By Brian Garrett, LEED Green Associate and Product Specialist, Labconco Corporation
One of a biosafety officer or laboratory manager's most vital functions is that of performing risk assessments. This multistep process becomes the backbone of a microbiology laboratory's biosafety plan, operating procedures, and, if done early, facility design.
WHITE PAPER: Monitoring Chemical Processes For Early Fault Detection Using Multivariate Methods
By Dr. Frank Westad, Chief Scientific Officer, CAMO Software
Multivariate statistical process monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment.
WHITE PAPER: Real-Time Facility Monitoring For Quality And Compliance
By Tim Russell, TSI Incorporated
A facility monitoring system (FMS) is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in real time.
CASE STUDY: Complete Pharma Packaging Accuracy Peace Of Mind
BROCHURE: Documentum Quality And Manufacturing Solution
BROCHURE: StandardPractice Digital File Protocol
PRODUCT: Integrity Bioreactors
» Supply Chain Integrity
GUEST COLUMN: Holding The Supply Chain Accountable
By Jeff Clark, 7P Solutions, LLC
Quality is certainly not new terminology in the pharmaceutical industry. However, I believe it is a term that is sometimes used too loosely within the pharmaceutical time and temperature supply chain.
APPLICATION NOTE: How To Avoid FDA 483s For Temperature, Humidity, And Other Controlled Environments
PRODUCT/SERVICE: Global Cold Chain Logistics
PRODUCT/SERVICE: Remote Monitoring: Prevent Damage In Shipping
PRODUCT/SERVICE: On-Site Packaging And Pickup
PRODUCT/SERVICE: Compact Temperature Controlled Shipper: CSafe SVS
PRODUCT/SERVICE: Cargo Companion Tracking Solution
» Downstream
POSTER: Semiautomated, Single-Use TFF Systems With An ‘Open Architecture' Design Maximize Flexibility And Allow Supply Chain Security
By Nick Hutchinson, Parker domnick hunter Process Filtration
Crossflow filtration used in bioprocesses is typically either microfiltration to clarify process streams or ultrafiltration to concentrate and diafiltrate the biopharmaceutical molecule.
Q&A: Taking Helium Integrity Testing Downstream
By Lori Clapper
A Q&A With Brent Todd, ATMI Life Sciences.
Q: Can you compare pressure decay and helium integrity testing?
A: Most bags today are tested by pressure decay, which is the industry standard, and it works fine — but there are some limitations to this technology. As customers begin using single-use assemblies further and further downstream, they have a need to increase their assurance of integrity and sterility in their single-use manifolds, bags, etc. That is why ATMI developed the innovative helium integrity tester (HITTM) — to do just that.
APPLICATION NOTE: Greater Productivity In Insulin Purification
ARTICLE: Mixing Predictions Without A Mixer
BROCHURE: HyPerforma Single-Use Mixer DS 300
BROCHURE: Sartobind Ion Exchange Membrane Adsorber Capsules
PRODUCT: Foresight Prepacked Plates And Columns
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