Industry Insights

1. Revolutionizing Drug Discovery: The Rise Of Fashionable Models 6/6/2024

   As a result of advancements in research technology, "fashionable models" such as organoids and organs-on-chips (OoCs) have been developed. Explore organoid and OoC technologies in detail.

2. Calculating The Probability Of Passing The USP Dissolution Test 1/9/2023

   Dissolution tests are performed during drug manufacturing to ensure that the drug product meets the standards specified in the United States Pharmacopoeia (USP). This article calculates the probability of passing the USP dissolution test using Microsoft Excel, and it can be modified for any combination of Q, mean, and standard deviations.

3. Lyobeads Are The Hottest Thing In Freeze Drying For Pharma 6/22/2023

   If the lyophilization process is applied to a single droplet of liquid, it creates a lyo ‘bead’ rather than a lyo 'cake.' Discover the potential of lyobeads and why they are an excellent alternative.

4. EMA'S eCTD 4.0 Workshop Seeks To Gear Industry For Implementation 4/12/2024

   As the EU prepares to implement the new eCTD 4.0 standard for regulatory submissions, the European Medicines Agency (EMA) is taking steps to ensure a smooth transition for industry.

5. Managing Extractables And Leachables In HPAPI Manufacturing 7/10/2025

   These contaminants can compromise the quality, stability, and safety of a drug product, and regulatory bodies mandate assessment to protect patients.

6. Applying QbD To Incorporate Excipients Into Drug Lifecycle Management 3/10/2021

   This article is the third in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation (IPEC Federation). In addition to life cycle management, the article delves into continued monitoring, multivariate analysis, continued product verification, and more.

7. Process Engineering's Key Role In Sterile Injectable Facility Design 2/24/2026

   Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.

8. How Two Life Sciences Companies Boosted R&D Productivity

   Explore how partnering with a third-party facilities management team helped two leading life sciences companies boost R&D productivity during the height of the covid-19 pandemic.

9. Common Pitfalls To Avoid When Building A Life Sciences Lab 7/3/2018

   Designing labs can be complicated. To stay competitive, it is crucial that companies adapt to market changes. New products and services may mean changes in operations. For companies that have lab spaces, this can be costly. Many companies make decisions based on saving money without planning ahead.

10. Valentine's Day Heartbreak: How To Let Your (Underperforming) CMO Partner Go 2/12/2020

    We read many articles about building relationships in the business environment to improve transactions, fortify the supply chain, and increase profits. But, what if the CMO has a deteriorating plant that directly impacts your production, or personnel turnover creates an environment of never-ending deviations and senseless retraining?