Bioresearch Online Downloads

BioPharma Industry Getting Comfortable With Complex Single-Use Devices

Fri, 10 Feb 2012 18:56:00 GMT

The rate of usage of disposables in biopharmaceutical manufacturing has increased substantially over the past six years in a variety of areas, but most notably for complex devices, that are also among the most expensive. By Eric Langer

Avoiding A Failed NDA Submission Via A Third-Party Gatekeeper

Fri, 10 Feb 2012 04:21:00 GMT

Companies specializing in the development, registration, and manufacture of pharmaceuticals will require no less than flawless management of data and tactical tasks to meet stringent FDA NDA (new drug application) submission requirements. By Diane Mauriello and William Cairns

405 Touch Microplate Washer Datasheet

Thu, 09 Feb 2012 20:38:00 GMT

The new 405T Touch Microplate Washer incorporates a state-of-the-art, high resolution LED backlit touch screen user interface for intuitive and flexible onboard instrument control of 96- and 384-well microplate washing.

Ready-To-Use Fluid Management Solutions For Cross Flow Filtration Systems

Thu, 09 Feb 2012 06:21:00 GMT

A selection of fluid management components from GE Healthcare's ReadyToProcess platform of disposable and single-use equipment was used to arrange buffer and sample management solutions for two large-scale filtration setups.

Propagation Of Influenza Virus In Vero Cells Using Cytodex* Microcarriers In WAVE Bioreactor* Systems

Thu, 09 Feb 2012 06:08:00 GMT

The aim of this work was to establish a process to produce influenza virus in Vero cell culture using single-use equipment.

An Explanation Of IPEC Guidelines

Thu, 09 Feb 2012 05:18:00 GMT

The required standards for manufacturing active pharmaceutical ingredients (APIs) are laid out in GMP (good manufacturing practice) requirements.

Does Joint Auditing Work? A Look Into The Rx-360 Pilot Program

Thu, 09 Feb 2012 05:06:00 GMT

Rx-360, an international pharmaceutical and biotech industry supply chain consortium, has set up a program of joint audits.

Ready-To-Use Fluid Management Solutions For Chromatography Systems

Thu, 09 Feb 2012 04:52:00 GMT

Purification Of A Monoclonal Antibody Using ReadyToProcess Columns

Thu, 09 Feb 2012 04:44:00 GMT

To reduce costs and shorten time to market, the use of plug-and-play technology is increasing in process development as well as in later-stage production.

A Rapid Filtration Method For Harvesting Mammalian Cell Culture Grown In Cellbag Bioreactors

Thu, 09 Feb 2012 04:38:00 GMT

Disposable bioreactors have gained widespread acceptance in cell culture applications because they provide a flexible resource for multiproduct facilities and speed the production of biomolecules.

Capture Of An Acid-Sensitive Recombinant Protein From E. coli Lysate Using Mixed-Mode Chromatography

Thu, 09 Feb 2012 04:36:00 GMT

HyperCel™ MEP, HEA, and PPA mixed-mode chromatography sorbents offer unique selectivity, are an efficient alternative to hydrophobic interaction sorbents, and can be used for intermediate step purification of monoclonal antibodies and for many other applications in the biopharmaceutical industry.

A Flexible Antibody Purification Process Based On ReadyToProcess™ Products

Thu, 09 Feb 2012 04:25:00 GMT

We have developed and used an efficient monoclonal antibody (MAb) purification protocol to reduce the level of aggregates from 10% to 0.4% in a two-step chromatography process giving a monomer yield of 81%.

Filamatic H-Series Automatic Inline Filling Machine Datasheet

Wed, 08 Feb 2012 19:43:00 GMT

Filamatic H-Series Automatic Inline Filling Machine

Single-Use Technologies Applied Throughout The Development And Manufacturing Of Biopharmaceuticals

Tue, 07 Feb 2012 21:37:05 GMT

While much has been written about specific applications of single-use technologies (SUT) in biopharmaceutical production, the breadth of their involvement is sometimes overlooked. From the earliest thaws of frozen cells to the final filling of protein-product solutions, SUT are in widespread use. By Michiel Ultee, Laureate Biopharmaceutical Services

Integration Of Remote Sensors Into Airborne Particle Counters To Monitor Critical Environments

Mon, 06 Feb 2012 06:39:00 GMT

As many of you already know, when a particle counter continuously monitors an aseptic manufacturing process, it is positioned to detect potential harm to the product.

Sentinel Clear™ XT Brochure

Thu, 02 Feb 2012 08:15:00 GMT

The Sentinel XT powered air purifying respirator system incorporates the most advanced technologies available including a brushless long life motor, a lightweight lithium polymer battery capable of delivering 12 hours of operation on a single charge, and easy decon features.

A Single-Use Bioreactor For Both Cell And Microbial Cultures: A Dream Becomes Reality

Thu, 02 Feb 2012 07:47:00 GMT

Application of single-use equipment is common practice in the biopharmaceutical industrial and academic field. Compared to the traditional glass or stainless steel bioreactors, single-use bioreactors offer clear advantages. By Nico M.G. Oosterhuis, Frank H. van Dongen, CELLution Biotech BV

Cell Therapy Process And Cost Model Simulations — Defining Process Improvement Strategy

Thu, 02 Feb 2012 07:33:00 GMT

Cell therapy is an emerging industry facing serious challenges. In this context, the role of the biotech industry is to provide dedicated technologies and support to enable the development of very promising cell therapy products. That is the objective of companies like ATMI lifeSciences.

Process Train Containment In CMO Operations Case Study

Thu, 02 Feb 2012 06:50:00 GMT

Handling HP/C compounds requires highly specialized facilities and controls.

Trends And Challenges In Bioresearch: Part II Chromatographic Analysis And Characterization Of Protein-Based Drugs

Wed, 01 Feb 2012 06:25:00 GMT

The commercial drug pipeline has made a dramatic shift from conventional small-molecule drugs to biologic-based pharmaceuticals in the past five years. By Tom Ricci