Industry Insights

  1. Are You Approaching LIMS Validation Correctly? 4/26/2021

    Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.

  2. What Parameters Can Help You Create Biologics Developability Profiles? 8/16/2023

    Developability profiles of biologics candidates help you avoid risk by collecting many quality attributes. Learn which attributes are evaluated during development and approaches for their measurement.

  3. Fast Track Designations For Your 505(b)(2) Drug Development Program 6/6/2022

    One FDA tenet is to get safe, effective drugs to market as soon as possible. Understand the details of Fast Track designation (FTD) and how 505(b)(2) products can qualify for this program.

  4. Emerging Technologies In The Delivery Of Proteins & Peptides 6/28/2021

    The limited ability to selectively deliver new drug molecules in the forms of peptides and proteins remains a significant challenge. Therefore, new materials and manufacturing techniques are emerging to meet the challenges associated with the formulation and delivery of biopharmaceuticals and pharmaceuticals.

  5. Elevate Your Life Sciences QMS: 5 Must-Have Features 10/8/2024

    With advanced features and better visibility into operations, uncover how MasterControl helps organizations navigate the complexities of the life sciences industry.

  6. Move Your Gene Therapy From Strategy To Reality 3/30/2023

    Implementing integrated solutions can provide cell and gene therapy manufacturing systems that work in concert to create a closed, automated, scalable, and performance-qualified network of unit operations.

  7. NGS-Based Assays In CGT: Enhancing Product Development 1/29/2026

    Examine how NGS brings essential clarity to cell and gene therapy development by enabling sensitive biosafety testing, detailed genetic characterization, and reliable stability monitoring.

  8. A Quality Agreement Primer: What To Include & Who To Assign It To 10/16/2020

    Part one of this three-part series on quality agreements discussed identifying key risks in partnering with contract companies and working with vendors. Part two explored the regulations and enforcement activities associated with quality agreements. In this final part, we examine what to include in quality agreements and who should be responsible for the assigned tasks.

  9. 6 Ways To Achieve Manufacturing Audit And Inspection Readiness 7/19/2023

    Achieving audit readiness is not a snapshot in time but an ongoing commitment to maintaining day-to-day compliance and quality standards. Let's explore how your manufacturing and quality teams can align efforts with these six practices to maintain audit and inspection readiness at all times.

  10. 5 Answers To FDA Computer System Validation Questions 4/8/2022

    We answer questions regarding the FDA's indication that a risk-based approach is compliant and significantly reduces the burden on life sciences companies.