GUEST COLUMNISTS

• Making FMEA More Robust With HACCP

  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.

• Repurposing An Aging Facility To Produce Cell & Gene Therapies: Layout & Design Considerations

  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.

• Discovering & Motivating Talent In The Life Sciences: Redefining “Other Duties & Responsibilities”

  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.”

• Trends In Bioprocessing CDMO Selection

  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.

• The Global Regulatory And Quality Environment For Biopharma Outsourcing

  It is critical that organizations looking to engage an external contract service provider be aware of new regulations to align their programs with the latest expectations for each relevant market.

• A Functional History Of Process Validation: Part 2 – The Key To A More Effective Future

  This article describes how process validation concepts can be evolved so the industry can better develop, manufacture, and launch the next generations of biopharmaceutical products.

• CBER Takes On More Oversight Of Biologic & Biosimilar Master Files

  This year saw a significant change in the process for submitting drug master files (DMFs) for biologic products: as of March 23, biologic-related DMFs are now administered by the FDA’s Center for Biologics Evaluation and Research (CBER). This transition of responsibilities presents a number of challenges for sponsors accustomed to working under the Center for Drug Evaluation and Research ( CDER).

• Environmental Monitoring And Sterility Assurance Control For Medical Devices And Combination Products

  The establishment of an environmental monitoring and microbiological control program for sterile medicinal devices is necessary to ensure microbiological safety and finished product quality. The level of environmental control is primarily dependent on the method of product sterilization.