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When Is Software The Answer To Regulatory Concerns About Your Investigations?

When Is Software The Answer To Regulatory Concerns About Your Investigations?

Jan 30 | John Ager, Technical Consultant, Life Science, Kepner-Tregoe, Inc

Document management software enables investigators to present the information used to reach conclusions clearly and concisely and it helps reviewers to track and approve investigations.
The Benefits of Professional Project Management

The Benefits of Professional Project Management

Jan 13 | Thorsten Vammen, Director at GEA Liquid Processing in Skanderborg, Denmark

Some companies feel that they can project manage new processing facilities themselves, bringing in sub-contracted help only when it’s needed. Self-managing is possible, but there may be a better way.
New Year - New Recall

New Year - New Recall

Jan 11 | Mike Auerbach, Editor In Chief

It’s only a few weeks in to the New Year and it’s sad to say that 2012 is already shaping up to be as bad as 2011 was in regards to pharmaceutical product recalls.
Happy Refurbished Year!

Happy Refurbished Year!

Jan 6

If you are willing to put in the effort, savings can be found in every arena — you can even find ways to save money on manufacturing equipment.

Featured Articles

Continuous Quality Verification as a Control Strategy for Biocontainers

Continuous Quality Verification as a Control Strategy for Biocontainers

Jan 18

An integrated quality/manufacturing approach to ensure the integrity of single-use biocontainers
Going for a Tumble

Going for a Tumble

Jan 17

Blending prior to compression, tabletting or packaging is a critical process where many aspects can go wrong both during the blend and after the blend.
The Expanding Vaccine Market

The Expanding Vaccine Market

Jan 16

Vaccines continue to be one of the brighter spots for  pharmaceutical companies in the current market, and revenues for vaccine products are expected to continue their double-digit growth in the future.
Spending Trends in the CMO and CSO Market

Spending Trends in the CMO and CSO Market

Jan 12

Where and how pharma and biotech companies are spending reveals much about the industry.

Manufacturing Technologies
Stainless Steel Reactor System For High Temperature/Pressure Applications

Stainless Steel Reactor System For High Temperature/Pressure Applications

Continuous Quality Verification as a Control Strategy for Biocontainers

Continuous Quality Verification as a Control Strategy for Biocontainers

Ultra-High Binding Capacity Anion Exchanger

Ultra-High Binding Capacity Anion Exchanger

Sartorius Stedim Biotech and G-Con Manufacturing Announce Global Collaboration

Sartorius Stedim Biotech and G-Con Manufacturing Announce Global Collaboration

Containers Available in a Variety of Sizes

Containers Available in a Variety of Sizes

Ultra-Low-Temperature Freezers

Ultra-Low-Temperature Freezers

Bag Ports that Meet Biopharm Requirements

Bag Ports that Meet Biopharm Requirements

Mini Bioreactor System

Mini Bioreactor System

Single-Use Transfer Assembly

Single-Use Transfer Assembly

High-Capacity Production Centrifuge

High-Capacity Production Centrifuge

3D Bag Fill (Side Gusset) Stainless Tank

3D Bag Fill (Side Gusset) Stainless Tank

Powerful and Flexible Multi-Channel Binding Analysis

Powerful and Flexible Multi-Channel Binding Analysis

Orbital Shaker for Use in High-Humidity CO2 Incubators

Orbital Shaker for Use in High-Humidity CO2 Incubators

Stand Aids Single-Use Fluid Transfers

Stand Aids Single-Use Fluid Transfers

Single-Use Filling Control System

Single-Use Filling Control System

Filling 3D Single-Use Bags in a Production Setting

Filling 3D Single-Use Bags in a Production Setting

Vapor-Compression Distillation Unit

Vapor-Compression Distillation Unit

Modular, Efficient Isolators

Modular, Efficient Isolators

Disposable Manufacturing Benefits from Advanced Process Control

Disposable Manufacturing Benefits from Advanced Process Control

Parallel Bioprocess Development Tool

Parallel Bioprocess Development Tool

Ozone Generator for Biopharmaceutical Applications

Ozone Generator for Biopharmaceutical Applications

Single-Use Bioreactor Systems

Single-Use Bioreactor Systems

Sartorius Stedim Biotech and GE Healthcare Life Sciences Sign Cross-Licensing Agreement

Sartorius Stedim Biotech and GE Healthcare Life Sciences Sign Cross-Licensing Agreement

Gamma-Stable Stir Bars

Gamma-Stable Stir Bars

Single-Use Bioreactor Systems

Single-Use Bioreactor Systems

Biocontainers for Cylindrical Drums

Biocontainers for Cylindrical Drums

Crystal-Clear Polyethylene Biocontainers

Crystal-Clear Polyethylene Biocontainers

Custom Tanks for Biopharm Applications

Custom Tanks for Biopharm Applications

Steam-Injection Heaters for Bio-Kill Applications

Steam-Injection Heaters for Bio-Kill Applications

Custom Drug-Delivery Film and Rod

Custom Drug-Delivery Film and Rod

Single-Use and Disposable Systems and Devices in the Biopharm Industry

Single-Use and Disposable Systems and Devices in the Biopharm Industry


Events Calendar

Informex 2012

February 14-17, New Orleans, LA

Biopharmaceutical Development & Production Week: Process & Product Validation

February 27-28, San Diego, CA

PittCon

March 11- 15, Orlando, FL

PDA Annual Meeting

April 16 - 20, Phoenix, AZ

More Events Calendar >>

Poll

Multimedia

Government Seeking $1T Campaign Against Alzheimer's

Government Seeking $1T Campaign Against Alzheimer's

Jan 18 | Video

Government advisors tried to set priorities for a national campaign to treat and manage Alzheimer's disease, which is projected to cost more than a trillion dollars in care by 2050. But as Dr. Jon LaPook reports, the plan does not include any funding.
ADHD Drugs in Short Supply

ADHD Drugs in Short Supply

Jan 11 | Video

Parents of children with attention deficit disorders are forced to travel from pharmacy to pharmacy in search of prescription medicines with no guarantees they will be available.
Study: Link Between Statins And Diabetes

Study: Link Between Statins And Diabetes

Jan 10 | Video

A recent study reveals that women who take statins may have a greate chance of developing diabetes.
Avastin Shows Promise in Fight Against Ovarian Cancer

Avastin Shows Promise in Fight Against Ovarian Cancer

Jan 5 | Video

Two recent studies show that Avastin, already approved for other cancers - but still controversial, could help women buy more time in their fight against ovarian cancer.

White Papers

50+ FDA Acronyms That Matter to Your Business

By: Vaisala | February 2, 2012

If you manage a GxP compliant manufacturing facility, or oversee storage and distribution of regulated drugs and devices, this e-book is a convenient and comprehensive reference of definitions, helpful insights, and links to additional resources that will give you fundamental understanding FDA regulations and to achieving Good Manufacturing Practices and FDA compliance.

The Benefits Of Conical Rotor Granulation And Coating Technologies

By: Vector | January 19, 2012

The Granurex® fluid bed conical rotor system utilizes multiple granulation and coating methods to produce spherical particles with a very uniform shape and size, particles with an exceptionally uniform coating, particles with multiple layers of coatings, particles with very high active content and particles with a high potency with yields of 97 % plus.

Performance Qualification of a New Hypromellose Capsule - Part II. Disintegration and Dissolution Comparison Between Two Types of Hypromellose Capsules

By: Capsugel | January 10, 2012

This Part II paper describes the disintegration and dissolution aspects of the qualification of a new hypromellose capsule (HPMC Shell 2). This new capsule does not contain any gelling agent, and is manufactured by a thermal gelation process. Rupture time of the carrageenan-containing capsule (HPMC Shell 1) and HPMC Shell 2, as measured by an improved real-time detection method, showed only slight differences that did not manifest in vivo.