Insights On Quality Control

  1. The Hidden Costs Of GMP Qualification And How Your Supplier Can Help 4/19/2022

    What should you be aware of before starting instrument qualification, and what can an instrument provider do to help you avoid the hidden costs of GMP qualification?

  2. Pharma Analysis & Quality Control: Trends From The Rapid Pharma Evolution 4/4/2022

    We look into how the pharma analysis & QC community envisions future trends and explore if the challenges faced by your peers are the same as yours.

  3. Rapid Microbial Detection Of Contaminants In Water Samples 4/7/2022

    Learn how rapid detection methods allow you to address contamination events sooner, avoid line shutdowns, release product to the market faster, and reduce warehousing costs.

  4. CDMO Collaboration: Foundation For Sterile Injectable Product Success 6/1/2021

    Explore how a small or medium size biotech or pharma company eveloping sterile injectables can benefit from the experience and assistance provided by a CDMO.

  5. Complex Pump-Driven Blending In A Bioprocess Application 7/8/2021

    There are quite a few applications that require multiple streams to converge into a single process flow. Two such examples are buffer formulation and liquid chromatography gradient elution. 

  6. Biological Indicators And The European Pharmacopoeia 5/10/2022

    Here we review the information in European Pharmacopoeia (EP) General Chapter 5.1.2, concerning BIs, which is more detailed and covers a wider scope than the previous version.

  7. Why Biological Indicators Survive A Validated Cycle 5/10/2022

    We review what to do should you ever find yourself in the situation where the probes indicate conditions that would render killed BIs, yet the units are testing positive.

  8. Understanding cGMPs For Phase 1 Investigational Drugs 12/21/2020

    Phase 1 investigational drugs are exempt from the requirements of the current good manufacturing practices (cGMP), as prescribed in Title 21 of the Code of Federal Regulations parts 210 and 211. 

  9. High Potency Fill Line 6/17/2021

    Whether it's a liquid or lyophilized product, we provide capacity, quality, and expertise to ensure a stable supply of your promising therapeutics.

  10. Analyzing Product Formulation Using Raman Microscopy 10/26/2020

    Raman spectroscopy is used to compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world, all containing the same API.