Contributing Editors

1. Closing The Perception-Vs.-Reality Gap In CGMP Quality Culture And Compliance 9/16/2020

   This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.

2. Design Thinking: A Shared Methodology Between Sponsor And CMO To Benefit Patients 9/15/2020

   Collaborative efforts made by the sponsor and the CMO, coupled with a well-defined process grounded in design thinking, can lead to improved patient compliance.

3. Unpacking FDA’s New Guidance On Controlling Nitrosamine Impurities In Drugs 9/10/2020

   On Sept. 2, 2020, the Federal Register announced the availability of a final FDA guidance, "Control of Nitrosamine Impurities in Human Drugs." This guidance is immediately effective and was not subject to the usual comment period “…because of the importance of providing timely information to manufacturers regarding risk assessments, testing, and other appropriate actions they should take."

4. One-Stop Shop Or Best of Breed? 3 CDMO Selection Case Studies 9/8/2020

   Following last week’s editorial by chief editor, Louis Garguilo, Ray Sison, xCell Strategic Consulting, has prepared three case studies and a detailed analysis of the best-of-breed and one-stop-shop outsourcing models. Learn to define a strategy that best fits your product requirements and aligns with your corporate objectives.

5. Dos And Don’ts Of Virtual Factory Acceptance Testing In Life Sciences 9/3/2020

   Performing virtual FATs (vFATs) can be a helpful solution in these new and uncertain times, though it does come with added risk. Without having the team on-site, remote FATs present a higher possibility for equipment to be shipped without meeting the end user’s requirements and functional specifications.

6. Strategic Outsourcing For Virtual Companies — Lessons Learned In The Trenches 8/31/2020

   A virtual company advancing a drug candidate into product development faces a deluge of challenges. The reality is you do need the assistance of pharmaceutical scientists and advice from industry professionals to help you navigate the twists and turns in the road.

7. Making FMEA More Robust With HACCP 8/27/2020

   Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.

8. Repurposing An Aging Facility To Produce Cell & Gene Therapies 8/24/2020

   Many life sciences companies are shifting their operations to encompass new life-saving cell and gene therapy products, also known as advanced therapy medicinal products. In many cases, this requires converting legacy manufacturing facilities to produce these new therapies.

9. Discovering & Motivating Talent In The Life Sciences: Redefining “Other Duties & Responsibilities” 8/21/2020

   How do we attract the right kind of talent to a role within our organizations? How do we take the same innovative approaches in our talent acquisition processes that we put into our products? One answer can be found in an often-overlooked bullet point in a common job description: “other duties and responsibilities as required.”

10. Trends In Bioprocessing CDMO Selection 8/17/2020

    Which CDMO characteristics do experienced outsourcers value the most when choosing a CDMO for biologic API production? Data from the past three iterations of ISR’s Bioprocessing Market Trends and Outsourcing Dynamics show the top selection metrics remain cosnsistent despite some shifts in ranks over the years. Learn which attributes to focus on as a sponsor or CDMO.