Quality Assurance

INSIGHTS ON QUALITY ASSURANCE

Beyond Protein A: Efficient Purification Strategies For Misbehaving mAbs
Next-generation antibody formats require more precise purification strategies. Explore how subdomain-specific VHH ligands can address structural heterogeneity, improve purity, and preserve stability.
Pharmaceutical Bioburden And Microbial Limits Testing
Explore how membrane filtration tools streamline bioburden and microbial enumeration while improving ergonomics and easing routine tasks in fast‑paced pharmaceutical microbiology labs.
Aggregate Analysis Of Tirzepatide
A new size exclusion method effectively analyzes Tirzepatide aggregates, demonstrating robust separation and reproducibility with minimal need for organic solvents or acidic modifiers.
Rethinking Column Care: Why Resin Preservation Is A Lifecycle Strategy
Chromatography resin is expensive, making proper maintenance vital. A comprehensive cleaning, regeneration, and storage program protects resin longevity, reduces risks, and ensures cost-effective biopharmaceutical manufacturing.

Engineering Excellence In Container Closure Integrity Testing
1/30/2026

Explore the critical factors that define a reliable container closure integrity method, as well as what truly distinguishes robust, reproducible testing in today’s demanding parenteral landscape.
Leverage Apps To Reduce Line Changeover Time From 14 Days To 3
6/26/2025

A global biopharma leader modernized its complex equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized, validatable SOPs.
Preventive Maintenance Isn't Enough For GMP Manufacturers
3/31/2026

Schedule‑based maintenance supports compliance but misses real‑time asset risk. Explore how GMP manufacturers are moving toward condition‑based and predictive strategies to modernize asset management.
The Benefits Of Low Endotoxin Products
6/16/2025

Minimizing endotoxin contamination is vital in manufacturing to protect patients. Learn more about rigorously tested, low-endotoxin products designed for critical cleanroom and sterile applications.
Where Does Container Closure Integrity Break Down In Cold Storage?
11/9/2026

Closure integrity qualified at ambient conditions can hide failures that appear only in deep freeze. Testing capped 2R vials across a descending temperature range pinpoints where the seal gives way.

Compounding Isolator: HC-IS Series

GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of High Potent Active Pharmaceutical Ingredients (HPAPI) for compounding activities.
Batch Manufacturing Software For Pharma

Visualize Batch Production Like Never Before

TrackWise Experion® Batch combines compact Experion distributed control, batch automation, and advanced visualization technology to provide a solution optimized for pharmaceutical, specialty chemical, food and beverage, and similar applications.
Computer Software Assurance (CSA) And Computer System Validation (CSV)

CAI’s Kneat: Data Ready provides you with best-in-class content and templates created by industry-leaders, giving you a headstart in implementing your own Kneat solution.

Kneat: Data Ready offers not only templates, but a validated out-of-the-box configuration that you can tailor to your business needs. Implement your Kneat instance in less than half the time.
Phase 1, 2, And 3 Clinical Supply

Upperton provides clinical supplies for Phase 1, Phase 2, and Phase 3, specializing in oral, nasal, and pulmonary dosage forms.
Two Decades Of Sterile Manufacturing Excellence

Ensure the highest quality and sterility for your injectable manufacturing with proven aseptic expertise. Expect customer-first service, regulatory excellence, and a commitment to long-term success.