Quality Control

INSIGHTS ON QUALITY CONTROL

Pharma Custom Isolator For Sterile Lab Process
This project showcases Germfree’s capacity to provide cutting-edge, bespoke solutions in pharmaceutical manufacturing, underpinning their dedication to innovation, safety, and quality.
Development Of Separation Methods For GLP-1 Synthetic Peptides
Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.
How To Double Up With A CDMO To Reduce Risk
Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.
Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements
Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

Organ-Chips Outperform Animal Models And Spheroids
8/2/2024

Examine how 780 human Liver-Chips were assessed for their ability to predict drug-induced liver injury from small molecules.
Advancing Cell Therapy Manufacturing: Rapid Sterility Testing
5/7/2024

The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.
Change Management In Pharmaceutical Quality Control Laboratories
10/29/2024

Gain expert insights into the driving forces behind change management, the associated obstacles within a QC lab, and best practices for guiding change when implementing new technology or procedures.
Expanding Capabilities In QC Analyses With Advanced LC Detection
11/26/2024

Today's quality control (QC) labs need instruments that can accurately take on a wide range of tasks. Discover a system that allows QC labs to enhance their capabilities and achieve various goals.
Challenges In Developing Medical Devices From Animal-Based Biomaterials In China
11/11/2024

Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

Our Science-Forward Approach To API Development, Manufacturing

Our highly skilled team of chemists and process engineers, combined with a science-driven project management approach, ensures seamless execution at every stage.
Test Method Development For Package Integrity Testing

A variety of test methods exist to challenge package quality and performance. The objective of a feasibility study is to evaluate if a recommended CCI solution works and establish the optimal test parameters and Limit of Detection (LoD).
Container Closure Integrity Testing Using Gas Ingress

The CCI Test Vessel provides a simple means of preparing samples for container closure integrity testing (CCIT) using the highly-sensitive and non-destructive laser-based headspace analysis technology. When combined with a LIGHTHOUSE FMS Headspace Gas Analyzer, the CCI Test Vessel offers a robust solution for container integrity tests on a wide range of container types and packaging conditions.
Tailored Process Development Services Designed For Success

Explore the design services offered by the Gibco Media by Design team including cell line development, media and feed panel evaluations, bioproduction analytics and more.
Used Applied Biosystems Genetic Analyzer, Model 3500

Applied Biosystems genetic analyzer, model 3500, integrated autosampler, 120 volts, serial# 24158-161.