FROM THE EDITOR'S DESK

  • Biohacking: Bringing Patient Centricity To Biologics Drug Development
    Biohacking: Bringing Patient Centricity To Biologics Drug Development

    The insulin market has yet to see generic competition. However, one team of scientists known as biohackers aims to identify a cost-effective protocol for the development of biosimilar wild-type insulin. Getting this treatment approved for market use may not be the primary goal for this group, but the Open Insulin project speaks volumes about the role patients and regular citizens can play in modern drug development.  

What Amgen And Biosimilar Makers Stand To Gain From AbbVie’s IPR Win

Amgen's IPR upset is being viewed as a big setback for the biosimilar industry. However, when considering the fact that Amgen is both an innovator and biosimilar maker, this loss carries with it an interesting benefit for the biosimilar industry.

4 Takeaways From Cell & Gene Therapy World

Cell and gene therapies hold great promise for patients. Now, the pressure is on the industry to develop processes and solutions that deliver these products economically.

UPS Pain In The Chain Survey: Pharma Makes Gains In Compliance, Partnerships

UPS' Pain in the Chain survey is one of the best ways to understand where life science companies stand on the issues making logistics a headache and keeping executives up at night. Since 2008, the survey of healthcare and life science supply chain professionals has attempted to determine the needs of these companies.

Cinfa Biotech: How Pharmacists Can Benefit Biosimilar Development

Developing a biosimilar is a highly scientific process. To ensure the biosimilar demonstrates the same efficacy and safety profile as the reference product, the science and clinical data have to match up. However, as Ruediger Jankowsky, managing director of Cinfa Biotech, says, a company should approach biosimilars from the “pharmacist’s perspective,” which extends far beyond the science of a biosimilar.

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GUEST CONTRIBUTORS

  • Who’s YOUR Yoda? What Star Wars Can Teach Us About GMP/Quality Mentoring
    Who’s YOUR Yoda? What Star Wars Can Teach Us About GMP/Quality Mentoring

    The newest round of Star Wars mania got me thinking about one of the themes in the movie series — mentoring.

  • 5 Questions To Ask About Biosimilars In 2016
    5 Questions To Ask About Biosimilars In 2016

    Not only did we see the U.S. release its first biosimilar, Zarxio, in 2015, but the Federal Circuit provided its first interpretation of the Biologics Price Competition and Innovation Act (BPCIA). Nevertheless, there are still a lot of unanswered questions, many of which are likely to be addressed in 2016.

  • Choosing Between Patent And Trade Secret Protection In A Biosimilar World
    Choosing Between Patent And Trade Secret Protection In A Biosimilar World

    Biologics are protected by patents that can slow or eliminate competition from generics as long as the patent remains in effect. However, as the biosimilar market grows, biosimilar manufacturers are just as likely to face competition from other biosimilar companies. But could filing for their own patents help biosimilar applicants limit competition from other biosimilar applicants? 

  • Regulatory Concerns For Facilities Of The Future:  Does Flexibility Come With A Cost?
    Regulatory Concerns For Facilities Of The Future: Does Flexibility Come With A Cost?

    Trends in biomanufacturing follow a slow cycle, partly due to the regulated nature of the industry and the substantial costs and risks that introducing a change in the process can bring. But that ignores the benefits that changes in bioprocessing over the past 10 years have brought, from better expression systems, to new modular and flexible facilities, sensors, and control systems for downstream operations.

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BIOPROCESSING WHITE PAPERS

A Cure For Pharmaceutical Supply Chain Complexity

The pharmaceutical industry lags in the sophistication and performance of its supply chains when they are compared with best-in-class companies in other industries. This is due to the complexity that has come with new drugs, more complex production technologies and evolving regulatory requirements. In this environment, integrating and aligning the supply chain makes it more flexible, bolstering operational performance and financial competitiveness.

Device Development For Pharmaceutical And Biologic Combo Products: Part II

In part I of this white paper, we discussed understanding the development strategy and product needs of pharmaceutical and biologic combination products. Hereinafter, we will discuss product requirements and device manufacturing variation.

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INDUSTRY INSIGHTS

Fed-Batch Supplements To Boost Cell Culture Performance

To increase the yield of a target protein, fed-batch culture is often employed in biomanufacturing processes. This application note demonstrates the enhanced performance of commonly used cell lines for MAb production when supplemented with HyClone™ cell culture supplements.

A Lifetime Study For Protein A Resin With CIP Cycle Testing

Many factors are required to assess and implement a protein A resin into a mAb purification process. Dynamic binding capacity, purity, operating flow rate and caustic compatibility are a few among many evaluation parameters. Resin lifetime is a key parameter that needs to be assessed as this is directly related to both installed resin volume and process costs. The resin should maintain performance parameters over the intended number of process cycles. This technote describes the effects of process cycling and caustic CIP on purification performance of Amsphere A3 over 100 cycles.

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BIO INDUSTRY POSTERS

  • Increase CHO Antibody Production Rapidly And Efficiently

    Chinese Hamster Ovary (CHO) cells are used extensively to produce recombinant proteins. One of the most challenging aspects of culturing recombinant CHO cell clones is providing the diverse nutritional requirements unique to each clone.

  • A New Single-use High-capacity Polishing Tool For mAB Purification

    This study compares dynamic BSA binding capacity of NatriFlo HD-Q with competing technologies to demonstrate performance in challenging process conditions (salt & phosphate background). It also demonstrates the effectiveness of NatriFlo HD-Q in removing process impurities (HCP, DNA & viruses) from industrial feed streams.

  • Provide Enumeration Results For Up To 24 Hours Post Venipuncture

    The use of flow cytometric analysis of peripheral whole blood to enumerate lymphocyte subsets is commonly used to assess the immunological status of patients in a wide variety of clinical conditions.

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ON-DEMAND WEBINARS

More Webinars On-Demand...

LIFE SCIENCE INDUSTRY EVENTS

Good Manufacturing Practices (GMP) – An Introduction February 9, 2016
1pm-2:30pm EST, Online Training
Analyzing and Understanding ISO 13485 Proposed Changes February 10, 2016
1pm-2:30pm EST, Online Training
Advanes and Progress in Drug Design February 15 - 16, 2016
London
Fundamentals of an Environmental Monitoring Program February 16 - 17, 2016
Bethesda, MD
Medical Devices - Effective Complaint Handling and Management February 16, 2016
1pm-2:30pm EST, Online Training
Events Calendar