Industry Insights

1. The Importance Of A Quality Management System 4/15/2021

   In the pharmaceutical industry, having a good quality management system is extremely important. This involves set processes to ensure that products continuously meet industry standards.

2. The Building Blocks For Successful CDMO–Pharma Relationships For Packaging Operations 12/4/2024

   The building blocks of such successful packaging relationships include a thoughtful approach to quality service agreements, a culture of transparency, and more.

3. 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.

4. RNA Therapeutics: New Market Research 11/14/2024

   According to our new market research, the RNA therapeutics industry is predicted to exceed $31 billion by 2032. This article shares key findings and trends.

5. 5 Best Practices For Improving AI Literacy In A GxP Environment 7/25/2025

   ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.

6. Need For Speed: The Key To Successful Multi-Market Product Launches 3/29/2021

   Launching a new drug in the European marketplace presents unique challenges. Numerous official working languages, complex independent regulatory requirements with an overarching framework, and the intricacy and scale of distribution are all characteristics of an EU launch. Jumping these hurdles is a given, but it’s the speed that makes the difference.

7. COVID-19 Vaccine Benefit-Risk Analysis/Ratio Using Real World Data 10/6/2021

   For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric articles such as this one, covering a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. The article provides a relevant, contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.

8. DART Studies: What Are They, And How Do They Fit Into Your Program? 8/27/2021

   Uncover how Development and Reproductive Toxicology studies are used to detect any effects of a drug within a complete reproductive cycle as relevant to humans.

9. Meeting The Small-Batch Pharma Packaging Challenge 12/14/2020

   A greater number of virtual biotech companies across the globe are launching lower-volume large molecule drug products to address a smaller patient population. Contract manufacturing and contract packaging providers configured for long-running, high-volume packaging processes to support small molecule drug products must now adapt their services, technology and people to meet the market’s changing needs.  

10. FDA Releases Pre-Launch Activities Importation Requests (PLAIR) Guidance 5/24/2022

    The FDA has finalized the draft guidance describing the policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for U.S. market launch based on anticipated approval of a pending NDA, ANDA, BLA, or combination product assigned to CDER.