Industry Insights

  1. Environmental Monitoring And Sterility Assurance Control For Medical Devices And Combination Products 8/11/2020

    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.

  2. Important cGMP Considerations For Implementing Electronic Batch Records 2/26/2021

    Mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met. 

  3. What To Expect From A Remote Inspection -- & How To Navigate It 7/23/2021

    Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.

  4. The IMDRF Cybersecurity Guidance: A Comprehensive Analysis 12/9/2019

    Principles and Practices for Medical Device Cybersecurity clarifies cybersecurity expectations for medtechs selling to a global market and is likely to serve as a blueprint for most regions’ local regulations, including the next round of FDA guidance documents.

  5. Vial Adapter Considerations For Cell And Gene Therapy Applications 4/21/2025

    Review features that need to be considered to choose a vial adapter for cell and gene therapy drug products and a case study where vial adapter transfer devices have been used to extract lentiviruses.

  6. The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter 1/31/2020

    This is the second article in a two-part series reviewing the MHRA’s publication of the GMP deficiencies for drug product published in October 2019. Part 1 identified and evaluated the critical and major deficiencies. Part 2 presents the 10 most frequently cited paragraphs for the 10 chapters and annexes with the most frequently cited deficiencies.

  7. The Formulation Development Journey

    Successful formulation journeys start with a roadmap where scientific studies and decision points create a route for understanding a molecule’s personality and its viability to help it along the way to the patients.

  8. Regulatory Considerations For First-Time Drug Developers 10/31/2024

    Navigate the challenging path from concept to clinical reality by partnering with an experienced CDMO that can provide the regulatory, clinical, and CMC expertise needed to move your therapeutic forward and bring it closer to patients in need.

  9. 3 Key Bottlenecks In Cell Therapy Supply Chains 6/10/2025

    Ensure your cell therapy program is prepared for the future by learning how to effectively navigate sourcing, logistics, and manufacturing challenges with confidence.

  10. The Downstream Process: Playing A Crucial Role In Extracting Essence 8/1/2024

    For bispecific antibodies (bsAbs), the goal of downstream process development is to develop a method for obtaining highly purified bsAbs with optimal recovery and quality.