Quality Control

INSIGHTS ON QUALITY CONTROL

Method Development For Forced Degradation Of GLP-1 Agonist
Gain insight into how a systematic approach reveals impurity behavior, strengthens selectivity, and refines chromatographic conditions to build a reliable degradation method for a GLP‑1 agonist.
Accelerate Biologics Product Release With Seamless Viral Testing
Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.
Improved GLP-1 Receptor Agonist Peptide Recovery
Discover how an innovative technology enhances LC-MS analysis of GLP-1 receptor agonists by minimizing peptide loss and improving assay sensitivity and consistency.
Cloud Migration In Regulated Environments: Validation Implications And Best Practices
Cloud adoption is essential for BioPharma growth, offering scalable tools for faster research. Success requires a risk-based approach to ensure data integrity and GxP compliance during the shift.

A System For Annex 1 Data, Reporting, And Interpretation Requirements
5/13/2026

Watch this tech expo video to discover how multi-dimensional sensor placement and integrated data dashboards optimize cleanroom environmental monitoring for Annex 1 compliance.
Shielded BSCs: Regulatory Requirement Or Risk-Based Engineering Solution?
4/20/2026

Master the balance between USP <825> aseptic standards and radiation safety. Learn how integrated engineering solutions ensure regulatory compliance while protecting both patients and personnel.
A CDMO's Take On Psychedelic Formulation
1/26/2026

Psychedelics show therapeutic promise, but face major formulation and regulatory hurdles. Advances in delivery and neuroscience may unlock new mental‑health treatments.
Characterizing The Physical Properties Of Spray Dried Powders
10/21/2024

Ensure the success of your spray-dried powder formulations by thoroughly assessing their physical properties early in the development process to optimize handling, stability, and performance in final dosage forms.
CDMO Audit Coverage: Key Focus Areas And Compliance Objectives
12/30/2025

CDMO audits focus on compliance, quality, performance, and relationships to reduce risk, ensure clear documentation, and align customer expectations with CDMO capabilities.

Integrated CDMO Solutions For Your Biologics

Advance biologic and bioconjugate programs with unified platforms, scalable GMP manufacturing, and specialized capabilities that move teams efficiently from early design to clinical readiness.
High-Risk Package Integrity Testing Systems

The ongoing R&D of PTI continues to build a powerful set of leading-edge inspection technologies that will bring patented and unique solutions to high risk packaging applications. There is continuous development in the field of creating new test methods for container closure integrity, seal integrity testing and package integrity testing.
Palltronic® Flowstar V Integrity Test Instrument

Filter integrity testing reaches a whole new level with the Palltronic Flowstar V featuring higher safety margins with a plug-and-play network integration.
Minimizing Uncertainty Throughout The Development Lifecycle

Wearable technologies that allow for dosing of high-volume biologics over a longer time need to be designed with manufacturability end-user needs in mind and must comply with the highest quality and regulatory standards.
Automatic Filling And Capping Machine In Aseptic Conditions

AseptiFill is the Aseptic Filling and Capping Machine specifically designed for Pharma & Biotech companies, focused on small batch production of injectable products for pre-clinical and clinical trial studies. Suitable for Ready-To-Use (RTU) vials ISO 8362-1 and RayDyLyo^®push-fit caps.