Guest Columns

  1. The Single-use Bioprocessing Bottleneck & Looking Ahead 4/18/2022

    Are you asking, What happened to the bags promised for my product? The single-use system bag market had been seeing strains as early as 2018, and COVID-19 made the demand worse. This article looks into the factors contributing to the demand. Normalization of the supply chain may continue to be delayed, but it will eventually even out.

  2. 5 Key Steps For FDA Q-Submissions 4/18/2022

    Most medical device designers and developers have some familiarity with the FDA's Q-Submission Program. Relatively few, though, know how to best use the program to effectively speed the product development process and, ultimately, get their devices to the market sooner. Follow these 5 steps for speedier time-to-market than your competition.

  3. Technical Due Diligence Considerations For Multi-Site Biopharma Acquisitions 4/14/2022

    Part 1 of this 2-part article series shared considerations for standalone biopharma manufacturing facility acquisitions. This article, Part 2, shares considerations for multi-site acquisitions when the seller is manufacturing part or all its products in-house.

  4. Rare Diseases’ Cost Burden On Patients 4/13/2022

    95% of rare diseases do not have approved treatments or therapies. Patients often bear the brunt of costs directly and indirectly. By understanding the cost drivers that a lack of available treatments poses for rare disease patients, pharma companies can identify unmet needs. Drug developers can improve the cost burden using 3 strategies.

  5. Biopharma Patents: Satisfying Descriptions For Claimed Ranges 4/11/2022

    In pharma patents, ranges are often recited in patent claims to broaden the scope of the claim coverage. Claims may also include a temperature range or pH range used in making a drug. This article shares the key takeaway for industry from a recently decided court case.

  6. Tech Due Diligence: Acquiring A Biopharma Manufacturing Facility 4/8/2022

    As a consultant, this author has been approached on several occasions to perform on-site technical due diligence for facilities that his clients were considering to acquire. In this article, he shares the considerations you should keep in mind when acquiring a stand-alone biopharma manufacturing facility.

  7. CGT Apheresis Service Market: Future Challenges 4/6/2022

    For improving the overall efficiency of the existing apheresis centers, we must address gaps in six key areas.

  8. A Better Path For CMO Relationships As The Pandemic Continues 4/6/2022

    In this article, we discuss how drug sponsors and service providers can better work together to continue down the path of outsourcing success that has been highlighted during the pandemic.

  9. FDA Issues Guidance On Initiation Of Voluntary Recalls 4/5/2022

    This guidance supports the requirements of 21 CFR Part 7 Enforcement Policy for drugs, medical devices, and biological products, and is being issued consistent with FDA's good guidance practices regulation. You may submit comments regarding this guidance to the agency at any time. 

  10. mRNA Vaccines: Key Considerations For Development & Manufacturing 4/4/2022

    This article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, good manufacturing practices, regulatory approval, and more. Address these challenges and have a speedier time-to-market.