Quality Assurance

INSIGHTS ON QUALITY ASSURANCE

Cambrex Scientist Spotlight: Daniel Kirschner
With a Ph.D. in bioanalytical chemistry from the University of Alaska Fairbanks, Kirschner brings nearly 15 years of experience in pharmaceutical development across biotech and CDMO sectors.
The Benefits Of Automating Your Requirements Traceability Matrix
The Requirements Traceability Matrix ensures every system requirement is verified through testing, supporting compliance, reducing risk, and strengthening validation efforts across development.
Design Testing Strategies To Develop A Drug-Device Combination Product
Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.
Regulatory Considerations When Choosing Stem Cell Media
Watch to explore key considerations for researchers moving from academia to industry or expanding their operations.

How To Overcome Common Single-Use Assembly Design Challenges
10/15/2025

Single-use systems offer major benefits in pharma manufacturing, but design complexity brings challenges. Learn how to overcome issues like scalability and quality assurance with integrated strategies.
Digital Transformation Essentials: AI Readiness, What Do You Need To Know?
6/22/2024

Unlock the full potential of AI and digital solutions with these practical steps to begin moving your BioPharma organization's goals forward with optimized data usage.
Validation Of A Sterilization Process: Part 2
9/9/2025

Gain essential insights into sterilization processes by exploring the Overkill method—an approach that ensures product safety through rigorous cycle development and validation.
Advanced Aseptic Filling Assembly Helium Integrity Testing
10/15/2025

Helium leak testing offers unmatched sensitivity for detecting micro-leaks in single-use fill-finish systems. Learn how tighter leak thresholds can strengthen aseptic processing and regulatory confidence.
A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems
10/3/2024

One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.

Sensors For Superior Process Control

Thermo Fisher Scientific offers single-use and reusable sensors for the measurement of pH, DO, biomass, and headspace pressure along with The Thermo Scientific™ TruSens™ transmitter blade which is a combined technology designed to monitor all conventional pH and DO sensors.
Observe Cell Viability With SpectraMax MiniMax 300 Imaging Cytometer

Observe the viability of your cells with the field-upgradeable cellular imaging option for the SpectraMax i3/i3x Multi-mode Detection Platform.
Accelerate Batch Releases With Right-First-Time Execution

Enforce standardized workflows while collecting data in real time, giving you the visibility you need to prevent deviations, review exceptions, and release batches faster.
Quality Standards

Learn how our Quality Management System (QMS) can accelerate your project’s path to market and enable the development, manufacture, and delivery of safe and effective products.
Quality, Compliance, And Regulatory Services For Life Sciences

The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.