FROM THE EDITOR

Quality Risk Management: Reduce Risk By Embracing It

Despite the resources available to help companies develop a QRM program, such as the ICH Q9, there are several challenges that commonly prevent a successful implementation. Ghada Haddad, director in global sterile and validation at Merck, suggests several best practices that can help overcome these issues. 

More From The Editor...

BIOPROCESS INSIGHT

More BioProcess Insights

BIOPROCESS CONTRIBUTING EDITORS

  • What Is the Role VCs Play In Partnering With Small Biotech?
    What Is the Role VCs Play In Partnering With Small Biotech?

    When Peter Young began planning his session proposal for this year’s BIO International Conference, he wanted to create a session worthy of your time. His session may be fascinating, but the young, a 35-year veteran of the biopharmaceutical industry, took some time to provide additional industry insights — ones you are not likely to gather by only attending his session.

  • CROs In A Business Exchange With Silicon Valley?
    CROs In A Business Exchange With Silicon Valley?

    As an applied economic theoretic, by driving out inefficiencies from the current model used by researchers to find and contract with CROs, the Science Exchange should improve the business model for drug discovery. But will all parties — Pharma/Bio, CROs and individual researchers — benefit equally? 

  • FDA News Roundup: Valeant, Pfizer, Boehringer Ingelheim, And More
    FDA News Roundup: Valeant, Pfizer, Boehringer Ingelheim, And More

    What FDA decisions have you missed recently?

  • Does Adversity Build Character Or Reveal It?
    Does Adversity Build Character Or Reveal It?

    Denice Torres is the president of McNeil Consumer Healthcare, a Johnson & Johnson company, and winner of HBA’s 2015 WOTY award. Listening to her acceptance speech reminded me of legendary pro football coach Vince Lombardi’s philosophy — “Adversity doesn’t build character, it reveals it.” 

  • Pharma’s Orphan Drug Binge: Redefining Corporate Social Responsibility?
    Pharma’s Orphan Drug Binge: Redefining Corporate Social Responsibility?

    A few months ago, Senator Elizabeth Warren launched a proposal for a “swear jar” bill that would require law-breaking Big Pharma companies to contribute 1 percent of the profits from each of their blockbuster drugs to NIH research. While this proposal was highly contested by members of the industry, I questioned if there couldn’t be a benefit to this bill apart from punishing law breakers and bolstering drug R&D. Would seeing pharma push more of its profits into research boost the industry’s image?   

More From Bioprocess Contributing Editors

FEATURED PRODUCTS

  • Single-Use Sampling Solutions
    Single-Use Sampling Solutions

    Three 60 is a completely disposable method of removing a sample from a closed sterile system. There are no parts which must be disassembled, cleaned, and reassembled.

  • Maximize Containment With The Task-Specific Workstation

    Flow Sciences's Task-specific workstations can meet the challenges and end user can experience with other laboratory workstations.

  • Cytation3 Cell Imaging Multi-Mode Reader
    Cytation3 Cell Imaging Multi-Mode Reader

    Cytation™3 combines automated digital microscopy and conventional microplate reading in one instrument. Its unique patent pending design is ideal for research and assay development applications in the field of cell biology.

  • Macro-Prep® High S Support
    Macro-Prep® High S Support Macro-Prep ion exchange media meet the demands of analytical, semipreparative, and process-scale applications. These rigid macroporous, hydrophilic 50 µm media provide exceptional capacity, resolution, and throughput in a chemically and mechanically stable form. Macro-Prep media operate well at low and medium pressures and exhibit minimal volume changes in response to variations in pH or ionic strength
More Products

BIOPROCESS ONLINE VIDEOS

BioProcess Online Videos

FEATURED SUPPLIERS

  • Sartorius Stedim Biotech
    Sartorius Stedim Biotech

    For the biopharmaceuticals industry, Sartorius offers a comprehensive, globally unique program of products and services, ranging from the discovery of active pharmaceutical ingredients to process engineering, from scale-up and production to compliance with regulatory steps.

  • Grace
    Grace

    Grace is a global provider of process manufacturing solutions supporting pharmaceutical and biotech industries. Our range of solutions includes peptide building blocks for API synthesis, chromatographic media and packing equipment for process purification, and multifunctional silica excipients for pharmaceutical formulation.

  • BioTek Instruments, Inc.
    BioTek Instruments, Inc. BioTek Instruments, Inc. is a global leader in the development, manufacture and sale of microplate instrumentation and software. The company's origins date back to 1968, when Dr. Norman Alpert, a physiologist at the University of Vermont Medical College, founded BioTek. Dedicated to providing test equipment solutions for the hospital safety and quality assurance markets, BioTek's Biomedical Division grew to become one of the largest and most successful companies in the field.
More Suppliers....

BIOPROCESS ONLINE INDUSTRY PARTNERS

 
 

 

ABOUT BIOPROCESS ONLINE

Bioprocess Online is the leading source of technical information and thought leadership for the biotherapeutic community. If you are a bioprocess engineer, scientist, bioprocessing manager, biotechnology producer, consultant, QA/QC, project manager, director, purchaser, marketer, or if you are involved in biopharm supply chain or facilities management, you now have access to a comprehensive Web community delivering the latest updates on the business and scientific information you need to succeed in your industry. From upstream to downstream processing through bioanalysis and biomanufacturing, our goal is to provide readers with the most up-to-date information about the issues, challenges, and news they care about most.

BioProcess Online is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

Please take a moment to join our community and discover the benefits of your free membership.

 

Newsletter Signup
By clicking Sign Me Up, you agree to our Terms and that you have read our Privacy Policy.

 UPCOMING TRAINING COURSES

Pediatric Clinical Trials: Special Considerations and Requirements

June 1, 2015
2pm-3:30pm EDT, Online Training

FDA GMP Inspections – Proven Preparation & Survival Techniques

June 2, 2015
1pm-2:30pm EDT, Online Training

Cost-Efficient/Cost-Effective Validation Protocols

June 3, 2015
1pm-2:30pm EDT, Online Training

Identifying and Closing the Training Gap in Clinical Research

June 9, 2015
1pm-2:30pm EST, Online Training
More Upcoming Courses

WEBINARS

More Life Science Webinars

BIO EVENTS

Pediatric Clinical Trials: Special Considerations and Requirements

June 1, 2015
2pm-3:30pm EDT, Online Training

Management of Aseptic Processing

June 1 - 3, 2015
Bethesda, MD

FDA GMP Inspections – Proven Preparation & Survival Techniques

June 2, 2015
1pm-2:30pm EDT, Online Training

Cost-Efficient/Cost-Effective Validation Protocols

June 3, 2015
1pm-2:30pm EDT, Online Training
More Events....