INSIGHTS ON QUALITY CONTROL
-
How LIMS Supports QC Scaling At Forge Biologics
Modernizing QC workflows with cloud-based systems eliminates paper inefficiencies, reduces errors, and accelerates reporting. Discover how streamlined processes improve compliance and enhance data visibility.
-
5 Common Pitfalls In CGT Facility Design Planning And Implementation
With shifting needs and requirements in advanced therapy manufacturing, embedding infrastructure flexibility is vital. Discover how to balance these variables for long-term success.
-
Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance
Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.
-
Leachables Method Development, Validation And Relevant ICH References
It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
-
The Pain Of Change – Could Suppliers Be Part Of The Cure?10/15/2024
Change is a constant in the pharma industry, but it doesn't have to be painful. Discover how suppliers can help ease the burden of regulatory change management and streamline essential processes.
-
Platform Strategy For Improving Manufacturability And Efficacy In Bispecific Antibodies7/15/2026
Novel bispecific antibody engineering overcomes assembly and manufacturability challenges, enabling scalable production while preserving therapeutic function, stability, purity, and product quality.
-
QC In The Whole Genome Sequencing Library Preparation Workflow3/19/2026
Take a look at how electrophoresis systems differ in sizing accuracy and why those distinctions matter for assessing high‑molecular‑weight DNA and protecting QC checkpoints across sequencing workflows.
-
A CDMO's Take On Psychedelic Formulation1/26/2026
Psychedelics show therapeutic promise, but face major formulation and regulatory hurdles. Advances in delivery and neuroscience may unlock new mental‑health treatments.
-
Cross-Site Work Within Cambrex's Network7/24/2026
Matthew Zart, Group Leader of Analytical Development, on what happens when a method arrives from another site — inheriting Phase II work from High Point and getting it commercial-ready for the QC lab.
QUALITY CONTROL SOLUTIONS
-
Bioburden testing and microbial limit testing are quality control tests for determining the total number of viable microorganisms of pharmaceutical and medical products. Thanks to its many cleverly designed features, the Milliflex Oasis® is a particularly productive and reliable membrane filtration method for performing bioburden testing in accordance with USP, EP, and JP recommendations, ensuring that patients can call upon microbially safe products.
-
Unlock higher yields and ensure regulatory success with a tailored process optimization program designed to eliminate contamination risks and stabilize biopharmaceutical workflows.
-
Scalable liquid manufacturing for diagnostic system fluids, buffers, and reagents helps protect supply continuity and ensure batch-to-batch consistency.
-
PTI Inspection Systems are scientific instruments being deployed for high risk packaging applications. The environments in which these systems operate is often highly regulated with test results having a significant impact on operational decisions. The reliability and sensitivity of a CCI test method is critical to assure that correct decisions are made to maintain product quality and patient safety. If PTI’s equipment is going to test your packaging, we aim to deliver the most effective solution. Feasibility studies offer a detailed glimpse into the technological capabilities ahead of critical purchasing decisions. Feasibility studies can also act as a preliminary test method for an application. The results from feasibility or method development testing can be rolled out to the production environment for rapid validation and deployment.
-
Establish safe barrier protection in minutes with a portable benchtop isolator. Secure containment for hazardous materials or inert gas processing across flexible laboratory scales.