Guest Columns

1. How To Close The Looming Life Sciences Data Storage Gap 12/9/2022

   Organizations across life sciences are facing a data storage dilemma: how to balance the need to store and potentially monetize mushrooming amounts of data while managing IT budgets and limiting the total cost of ownership.

2. ICH Issues Draft Guideline On Viral Safety Evaluation Of Biotech Products 12/8/2022

   Viral contamination can affect raw materials, cell culture processes, bioreactor contamination, and downstream processing. ICH's new draft guideline titled Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin is available for public comment through the FDA (ending Jan. 14, 2023) and through the EMA (ending Feb. 10, 2023).

3. CDMO Partnerships In Early Development Aren’t Always The Best Choice 12/7/2022

   This article looks at the needs and challenges biotech organizations face during the manufacture of therapies, how they can reduce cost, and how establishing — or not establishing — partnerships with CDMOs can help get their therapies to patients faster.

4. Rising Interest Rates Skew Risk-Return Paradigm For Life Sciences 12/6/2022

   Rising interest rates, imploding cryptocurrencies, and erratic equities markets have upended assumptions about risk and returns during 2022. The “risk-free” rate has surged to more than 4% as of late November. Your pharma, biotech, or medical device company looking to raise cash needs to take the key considerations shared in this article into account.

5. Where Do We Stand On Adopting Continuous Manufacturing For Biologics? 12/5/2022

   Continuous manufacturing offers productivity and cost-saving benefits among other things, but technical and regulatory challenges have slowed uptake. Speeding up adoption will require innovation and knowledge sharing within the industry and regulatory support from the FDA.

6. 5 Steps To Eliminate Weak Links In Your Data Governance 12/2/2022

   Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.

7. Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview 12/1/2022

   This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.

8. Create The Correct Checklist To Land The Best CDMO 11/29/2022

   When considering outsourcing strategies, develop the right kind of checklist that considers human dynamics. This is not a script, nor is it static. Flexible enough to meet the needs of the project and the personnel, this spec will help you create frameworks, master service agreements, and quality agreements for best oversight of your supplier.

9. A Methodology To Support Particle Investigations In Biopharma Products 11/22/2022

   Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.

10. 1 Year Out, Where Do We Stand On DSCSA Implementation? 11/21/2022

    This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.