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White Paper: For Potent Product, Reliable Resource Is Required

Fri, 12 Mar 2010 04:35:00 GMT

Probiotics, products that contain scientifically documented live microorganisms, are increasingly being used by consumers around the world. Market growth could potentially be significant, offering sizable opportunities to scientific-minded companies aware of the complexities of probiotics. By Ropack, Inc

Datasheet: SART SystemT

Wed, 10 Mar 2010 16:23:00 GMT

The SART SystemT is designed to allow aseptic liquid transfer between two areas with different containment classifications. The SART SystemT consists of an external port, an internal port and a disposable connection device - Gammasart ATDT.

Datasheet: Opta� SFT

Wed, 10 Mar 2010 16:16:00 GMT

The Opta� SFT Sterile Connector is a single-use device, composed of pre-sterilized female and male coupling body, that allows a sterile connection in biopharmaceutical manufacturing processes.

Brochure: BIOSTAT� CultiBag RM

Wed, 10 Mar 2010 16:11:47 GMT

The BIOSTAT� CultiBag RM is the new generation of disposable bioreactors utilizing rocking motion for mixing with low shear. The combination of a new generation of Sartorius Stedim Biotech engineered control capabilities launches the disposable bioreactor system into a new era of cultivation.

White Paper: Computer System Validation And FDA Inspections

Mon, 08 Mar 2010 05:20:00 GMT

Often, the FDA comes to inspect your facility for reasons other than your computer system validation (CSV) program. However, because so many of our business processes are governed by electronic systems, the topic of CSV inevitably comes up during the course of an inspection. By Michael Gregor

Article: A Focus On The Science And The Business

Mon, 08 Mar 2010 05:08:00 GMT

RXi Pharmaceuticals was founded by one of the codiscoverers of the RNAi mechanism and recent Nobel laureate Craig Mello, Ph.D., professor of molecular medicine at University of Massachusetts. Dr. Mello is still a member of the company's scientific advisory board. By James Netterwald, Ph.D.

White Paper: Can Your Cold Chain Hurt Your Company's Brand?

Mon, 08 Mar 2010 05:02:00 GMT

Consider how important it is for the physicians administering your drugs to have a good perception about your company. And by good perception, I don't mean that they just are satisfied with the drugs you produce, I mean they like the drugs and your company in general; they feel confident that you're top-notch. Sure, there is a lot of marketing that goes into creating that perception, but what you may not realize is that your cold chain processes and technologies can have just as big an impact on a customer's perception as any advertising or marketing campaign. By Dan Schell, Life Science Leader magazine.

White Paper: Fiscally Fit Facilities: A New Look At What It Means To Be Lean

Mon, 08 Mar 2010 04:55:00 GMT

Optimizing the fitness of a manufacturing facility requires a multifaceted approach, using a combination of lowering operating expenses, increasing throughput, and reducing inventory. By Cindy Lieberman

Feature Article: Demonstrating Comparability For Well-Characterized Biotechnology Products

Thu, 04 Mar 2010 15:56:00 GMT

Challenges and approaches in demonstrating comparability of a well-characterized biotechnology product after manufacturing changes can be as varied and complex as the products themselves. Participants at the January 2005 CMC Strategy Forum sought to discuss and agree on common implementation strategies for different manufacturing change scenarios. By John Towns and Keith Webber

Feature Article: Integrating Modular Design — Build Execution Strategies Into Biotech Projects

Thu, 04 Mar 2010 15:47:00 GMT

One of the earliest and most important decisions in a biopharmaceutical facility construction project is choosing a project execution strategy. This choice affects cost, schedule, and quality of the immediate project as well as further operations throughout the facility life-cycle. By Kevin L. Koffke and R. Grant Merrill

Case Study: Thermo Scientific CONNECTS At GPSG Brazil Delivers Enterprise-Level Productivity Linking Laboratories To ERP

Thu, 04 Mar 2010 05:19:00 GMT

Pharmaceutical manufacturing companies such as GPSG Brazil are required to control the quality of their analyses according to specific US FDA guidelines, which apply to electronic format records that are created, modified, maintained, archived, retrieved or transmitted in their laboratories. These regulations are valid even for records that are not used in a submission, such as training records and SOPs. By Thermo Scientific Brand Products, Part of Thermo Fisher

Poster: Promega's ADP-Glo™ Kinase Assay Performed On BMG LABTECH's PHERAstar FS And POLARstar Omega

Wed, 03 Mar 2010 05:39:00 GMT

BMG LABTECH presented the poster Promega's ADP-Glo Kinase Assay performed on BMG LABTECH's PHERAstar FS and POLARstar Omega at LabAutomation 2010. In this poster we discussed the ability of the PHERAstar FS as well as the POLARstar Omega to perform the ADP-Glo™ assay from Promega in a 384-well format. By BMG LABTECH, GmbH

Technical Bulletin: Thermo Scientific Nalgene InVitro Biotainers

Tue, 02 Mar 2010 08:50:00 GMT

Thermo Scientific Nalgene InVitro Biotainers are safe, sterile, single-use containers ideal for storage, transport and freezing applications of critical reagents and bulk intermediates such as vaccine and protein therapeutic preparations.

Application Note: In-Situ Micro-Volume Bicinchoninic Acid Protein Assay

Tue, 02 Mar 2010 05:09:00 GMT

Standard protocols for bicinchoninic acid (BCA) assays using vials or microplates have been modified for use with the Take3™ Multi-Volume Plate suitable for micro-volume analysis. Protein samples and BCA working reagent are added sequentially directly to the microspots of the Take3 plate, incubated, then read on the Epoch™ Multi-Volume Spectrophotometer. By Peter Brescia, MSc. and Peter Banks, Ph. D., BioTek Instruments, Inc., Winooski, VT

Article: How To Improve Your Implementation Of Two-Dimensional Preparative HPLC

Fri, 26 Feb 2010 11:19:00 GMT

The biologics and natural product industries rely heavily on separation technology. Sample analyses are undertaken on the analytical scale, and isolation and purification are undertaken at the preparative scale. Key target components are often isolated to provide standard reference materials for future product quality assurance testing. By R. Andrew Shalliker and Georges Guiochon

Datasheet: Early Formulation Development

Fri, 26 Feb 2010 05:08:00 GMT

Patheon and Solvias AG have partnered to provide customers with integrated early development services.

Datasheet: Cytotoxic Contract Manufacturing

Fri, 26 Feb 2010 05:02:00 GMT

BSP is a partner alliance of Patheon, providing solutions to develop and manufacture high potency cytotoxic products.

Podcast: Redefining The CRO

Fri, 26 Feb 2010 04:58:00 GMT

Listen to Bob Burford Ph.D. Managing Director, Aptuit Consulting.

Datasheet: Low Solubility Compounds

Fri, 26 Feb 2010 04:58:00 GMT

For tackling the bioavailability challenges of BCS (Biopharmaceutical Classification System) class II and IV compounds, proven formulation development, analytical and manufacturing capabilities are available at Patheon's facilities.

Datasheet: Pharmaceutical Drug Delivery

Fri, 26 Feb 2010 04:58:00 GMT

AcuForm™ technology has a proven track record of once-daily dosing, improved treatment tolerability, and enhanced patient compliance. It can be a preferred delivery system for new chemical entities, or a differentiating formulation for life cycle management.