EDITOR'S DESK

  • DIA Biosimilars Conference Reveals “More Questions Than Answers”
    DIA Biosimilars Conference Reveals “More Questions Than Answers”

    During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”

Pfizer’s Cultural Evolution To “Tell The Biosimilar Story”

Pfizer's Tracy Dianis presents a candid look into the cognitive and cultural transition that needed to occur in her own mindset, as well as within Pfizer, in order to embrace biosimilar development.

Biosimilar Regulatory Best Practices: Don’t Fear Exploration

In the first of this two-part article, Sandoz's Cindy Cao shares lessons learned from working with the FDA and reveals that there is still a lot of room for exploration and innovation in biosimilar development.

What These Two Mottos Must Mean For The Biosimilar Industry

I recently attended the Association for Accessible Medicines (AAM) Biosimilars Council’s Leading on Biosimilars conference.In addition to the many tidbits of knowledge I took away from this event, two terms kept resurfacing throughout the conference I feel are worth delving into more deeply.

Pfenex’s New CEO Sizes Up Biosimilar Industry’s Future

Newly-appointed Pfenex CEO, Eef Schimmelpennink, faces the challenge of determining how to adapt Pfenex to a constantly changing future. Though it's still very early in his tenure, Schimmelpennink highlights some areas he will keep in mind as he steers Pfenex's future biosimilars onto the market.  

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GUEST CONTRIBUTORS

  • An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection
    An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection

    This article discusses how the maximum safe surface residue (MSSR) can be combined with the visual residue limit (VRL) to assess the acceptability of visual inspection for detecting the possibility of compound carryover in shared facilities.

  • The FDA/EU Mutual Recognition Agreement — What You Need To Know
    The FDA/EU Mutual Recognition Agreement — What You Need To Know

    The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.

  • Bioprocessing Trends To Watch In 2018
    Bioprocessing Trends To Watch In 2018

    The current situation in biopharma is exciting, with new technologies, biosimilars, cellular and gene therapies, and opportunities in emerging markets.  And these innovative platforms are going to continue to need improved manufacturing technologies in the future.

  • Best Practices For Data Integrity Oversight At Your Contract Manufacturer

    Part 1 of this two-part article addressed FDA warning letter enforcement actions and discussed things that can go awry in these relationships related to data governance and data integrity. In Part 2, we turn our attention to health authority GMP guidance on contractual relationships and best practices that should be considered in this area.

  • Process Analytical Technology: Benefits Of Spectroscopic Tool Use

    To increase familiarity with process analytical technology (PAT), this article provides examples that illustrate where traditional analytical tests could be supplemented, improved, or replaced with these new tools, such as identity testing, concentration verification, and concentration monitoring (in real time).

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BIOPROCESSING WHITE PAPERS

  • Virus Retentive Filtration In Biopharmaceutical Manufacturing

    There are two different schemes to claim modular retrovirus clearance in place of performing molecule-specific laboratory scale retentive filtration studies.

  • Best Practices For Chemical Inventory Management

    Companies that utilize chemicals in their labs and their manufacturing processes must manage those chemicals in a safe environment in accordance with government regulations. At a minimum, to ensure that this is accomplished, a system for managing information about the chemical safety and inventory data should be established and maintained. Best practices, on the other hand, take this minimum and leverage the management of the chemical inventory by taking full advantage of the people, processes, and technology involved. This white paper delves into the best practices involved in managing chemical inventory to achieve the most effective, holistic chemical inventory system.

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INDUSTRY INSIGHTS

  • Rapid Single–Step Purification Of Proteins From Whey
    Rapid Single–Step Purification Of Proteins From Whey

    Whey proteins play a vital role in the formulation of food supplements because of numerous desirable nutritional and functional properties. This case study depicts the establishment of a process workflow for whey purification using Nuvia S and Nuvia Q Ion Exchange Resins.

  • Selecting The Optimal Resins For Aggregate Removal
    Selecting The Optimal Resins For Aggregate Removal

    The success of any biologic drug depends greatly on downstream purification. Among the challenges process scientists face during this process is the formation and/or removal of aggregates of monomers.

  • TCO Considerations For Biopharma Manufacturing Facilities
    TCO Considerations For Biopharma Manufacturing Facilities

    whether you’re building a plant for a small molecule drug or a biologic, you need to be able to do so faster and in a more agile manner than ever before. 

  • Expanding Single-Use Biomanufacturing Into New Locations
    Expanding Single-Use Biomanufacturing Into New Locations

    If you have decided to add capacity in-house, you need to consider which location enables you to most efficiently and effectively meet demand. Having knowledge of the local operating environment as well as regulatory considerations is vital. Where you don’t have this knowledge in-house, finding a supplier with first-hand experience of operating in a region can help fast track your project.

  • Make The Right Container Choice For Critical Environments
    Make The Right Container Choice For Critical Environments

    There are a number of factors to be taken into consideration when selecting containers for use within a critical environment.

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LIFE SCIENCE INDUSTRY EVENTS

Auditing Validated Computer Systems In A GxP Environment December 12, 2017
1pm-2:30pm EST, Online Training
Building An Effective GMP Training System: A Risk-Based Approach December 19, 2017
1pm-2:30pm EST, Online Training
Stability Programs - Key Factors in Meeting FDA/ICH Expectations January 17, 2018
1pm-2:30pm EST, Online Training
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