Pharma-regulated QC Resources to Get the Best of Your Analytics

Up-to-date access to application notes, white papers, infographics, and more

Welcome to your one-stop resource for pharma-regulated quality control testing. Here, we provide a wealth of information and resources designed to support professionals in the pharmaceutical industry. From the most recent advancements in quality control testing to in-depth guides and tools, we are committed to helping you maintain the highest standards of quality and safety in pharmaceutical production.

Pharmaceutical Quality Control Resources by Category

Pharmaceutical Microbiology QC

Application Note

Beta Test: Real-time PCR-based Presence/Absence Test

Explore detection of bacterial contamination in ATMPs with this real-time PCR-based test.

Application Note

Rapid, Real-Time PCR-Based Detection of Microbial Contaminations

Explore how to detect contaminations in high cell density Jurkat-, HPBMC- and CHO- Cultures.

Microbial forms in vibrant colors and distinct shapes, highlighting the diversity of microscopic life
Application Note

Enhancing ATMP QC With Microsart® ATMP Sterile Release

A Comparison With Alternative Solutions

3D illustration of cells
Webinar

The Invisible Threat: Mycoplasma Contamination in Cell Cultures

Watch this webinar to explore the causes, challenges, and effective solutions for maintaining Mycoplasma-free cell cultures.

EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Manufacturers
Article

EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Ma...

PDF 839.9 KB
3D illustration of cells
Webinar

Real-Time PCR-Based Mycoplasma Testing

Explore challenges and solutions in Mycoplasma detection for Advanced Therapy Medicinal Products (ATMPs). 

Webinar

Continuous Microbial Air Monitoring

Webinar on gelatin membrane filtration for microbial air monitoring in pharma, covering sterility, EU GMP, risk management, and sampling methods.

Application Note

Enumeration of Clostridium perfringens

Microbiological Performance Testing of Membrane Filters in Accordance with EN ISO 7704:2023

Webinar

Importance of Data Integrity in Microbiology Labs

Marie Dorna discusses the importance of data integrity in microbiology labs.

Lab technician operating a Sterility Testing Lab Pump - Sterisart Universal Gen 4 inside of a Skan Spectra isolator - close view
Webinar

Ready to Embrace the Digital Age with Modern Sterility Testing?

This webinar provides an in-depth look at the latest developments in sterility testing technology.

Webinar

The Future of Qualification and Compliance

The panel will emphasize compliance, risk assessment, and advanced techniques in pharmaceutical microbiology

Webinar

Best Practices for Risk-Based Microbiology Instrument Qualification

This webinar highlights the importance of equipment qualification in a validated pharmaceutical environment.

Microbiological QC 101 article cover
Article

Microbiological Quality Control 101

Learn about ensuring safety in biologics production, preventing and eliminating mycoplasma contamination, and microbial limits testing

eBook

Fortifying Contamination Control

Biocontamination Control Strategy: FDA insights, cleanroom tips, and barrier tech

Application Note

Recovery of Burkholderia cepacia Complex Species

Using Microsart® @filter

poster thumbnail
Poster

How to Prevent Mycoplasma Contamination and Spread

Download this poster to learn how to prevent mycoplasma contamination and spread in your cell culture lab.

How to Prevent Mycoplasma Contamination in Cell Cultures infographic preview
Infographic

How to Prevent Mycoplasma Contamination in Cell Cultures

Learn five tips for preventing mycoplasma contamination in the cell cultures in this easy-to-understand infographic.

Webinar

Implementation of a Real Time PCR Based Method For Sterile Release Tes...

Understand how real-time PCR can be implemented as sterility testing method for ATMPs

Robust Microbial Recovery After Filtration of Disinfectants Using Microsart® @filter PVDF
Application Note

Robust Microbial Recovery Using Microsart® @filter PVDF

Learn how the Microsart®@filter PVDF is a robust solution that ensures effective recovery of microorganisms after filtration of various disinfectants.

cosmetic production line
Article

Bioburden Testing of Viscous Samples

How to Achieve Pharmacopeia-Compliant Bioburden Testing of Viscous Samples

Flyer

Rapid detection of Mycoplasma and other cell wall-less bacterial speci...

PDF 894.8 KB
Application Note

Detection of cell wall lacking bacterial species using the real-time P...

PDF 501.0 KB
Technical Note

Microsart® ATMP Mycoplasma Detection Kit - Impact of repetitive freezi...

PDF 1.1 MB
Flyer

Bacteria, Fungi, and Mycoplasma Detection Kits - DNA extraction and re...

PDF 976.4 KB
Flyer

Rapid Sterility Solutions: Microsart® ATMP Sterile Release

PDF 932.6 KB
Flyer

Rapid MycoplasmaDetection: Microsart® AMP Extraction and Microsart® AT...

PDF 815.3 KB
Rapid Solutions: Microsart®️ ATMP Bacteria, Fungi and Mycoplasma flyer cover
Flyer

Rapid Solutions: Microsart®️ ATMP Bacteria, Fungi and Mycoplasma 

PDF 759.1 KB
Poster

Detection of Nucleic Acid Traces

A PCR Kit Manufacturer Perspective

Application Note

Influence of Incubation Conditions on Microbial Recovery

Download the application note and discover more about the influence of incubation conditions on microbial recovery on R2A Agar

microsart
Application Note

Filtration of Viscous Samples for Microbiological Quality Control

Optimizing microbial enumeration in viscous substances is critical. This study explores how temperature & dilution with IPM impacts, using Microsa...

Infographic

Solutions for Microbiological Quality Control: Continuous Active Air M...

Discover three key air monitoring considerations for (c)GMP environments and how Sartorius solutions support compliance with Annex 1 guidelines.

Benchmarking of Two Mycolplasma Real-time PCR Kits suitable for Release Testing According EP 2.6.7
Application Note

Benchmarking of the Microsart® AMP Mycoplasma Kit

This application note presents a benchmark study comparing the capabilities of two different qPCR kits for the detection of Mycoplasma.

Application Note

Continuous Microbial Air Monitoring in Clean Room Environments

Be prepared for Annex 1 and EN17141 regulations and download our application note.

The Sterisart®️ Septum Enables Reliable Sampling from a Closed System Sterility Testing Unit
Application Note

The Sterisart® Septum Enables Reliable Sampling

In this study, we evaluated the Sterisart® closed system sterility testing device, with a septum, for the recurrent sterile extraction of samples.

thumbnail
Infographic

Microbiological QC Biopharma Production Process

Discover Sartorius solutions for Microbiological QC throughout the biopharma production process, from process development to final release.

sterisart ebook thumbnail
eBook

Sterility Testing Playbook

This interactive PDF/playbook helps you to easily identify the right sterility testing canister for your application. The playbook also provides an ov...

First Final Release Test of ATMPs Prior to Treatment Validation of a qPCR-Based Rapid Sterility Test
Poster

Rapid Sterility Testing for Cell Therapy Quality Control Poster

In this poster, a validation study was designed to evaluate bacterial and fungal detection capability.

Brochure

Microbiological QC Solutions: Performance You Deserve, Compliance You...

PDF 2.8 MB

Bioanalytical QC

Article

Assuring Accuracy, Preventing Fraud

The Critical Role of Validation in Bioanalytical Methods

BLI Technology for Comprehensive Characterization of Biotherapeutics
eBook

BLI Technology for Comprehensive Characterization of Biotherapeutics

Discover expert insights into the BLI technology that's revolutionizing quality control in the biopharmaceutical industry.

Brochure

Octet® BLI Kinetic Screening In Biosimilar Development

Discover how a single analyte concentration can be used to accelerate biosimilar development when using an Octet® BLI system.

Webinar

On-Demand Webinar: Accelerating Biosimilar Development Using Octet®️ B...

Learn how the high-through-put Octet instruments and reagents can be used to design assays that rapidly characterize multiple attributes of antibody b...

Application Note

Biosimilar Assessment

Novel, High-Throughput Approach for Testing Development Samples

eBook

Improved Efficiency with Label-Free Bio-Layer Interferometry (BLI)

Discover how Octet® BLI systems revolutionize quality control (QC) testing for increased efficiency, productivity, and compliance.

Flyer

AAV Capsid Titer Data 80 Percent Faster Compared to ELISA

PDF 314.3 KB
Application Note

Modernize Biopharmaceutical QC Testing to Increase Efficiency

Up to 2x faster and with the ability to process 40x more samples per day, Octet BLI technology is an ideal replacement for ELISA, SPR, and HPLC

Application Guide

Ligand Binding Assays That Meet Compliance with Octet® BLI Systems

Octet® GxP packages support the GMP compliant implementation, including 21 CFR Part 11 software, validation packages, and biosensor validation support...

Validated Quantitation and Activity Assay of Antibody Fragment Molecule (Fab) for Process Development and Quality Control
Application Note

Validated Quantitation and Activity Assay of FaB

For Process Development and Quality Control

app note thumbnail
Application Note

Potency Assay Development Qualification and Validation Strategies

A method for evaluating the binding of an Fc gamma receptor III (FcγR) molecule to the widely characterized NIST mAb.

Application Note

MAb Quantitation Protein A HPLC vs Protein A Bio-Layer Interferometry

Rapid, accurate and cost-effective quantitation of monoclonal antibodies (MAbs) is essential for bioprocessing.

app note cover
Application Note

Enhancing Efficiency and Economics in Process Development and Manufact...

PDF 372.5 KB
Interview

The Importance of Sample Preparation and Filtration

An interview with Stephanie Schweizer

Physiochemical QC

White Paper

Weighing the Importance of Lab Balances in Quality Control Labs

Explore the importance of lab balances in QC labs, the advanced features of ultrahigh-resolution balances, and regulatory compliance.

Infographic

Preparation of Bioassays and Serial Dilutions in Microplates

PDF 647.2 KB
Lab Water Workflow Graphic Illustration
Webinar

Combatting Water Contaminants

We address the issues of contaminants including microplastics and PFAS contamination of water sources and introduce solutions from Sartorius

Infographic

Analytical Samples & Standards Infographic

Webinar

Pave Your Weigh to Accurate Analytical Results

Explore sample preparation challenges, the importance of meeting minimum sample weight guidelines and the importance of proper cleaning.

Analytical Samples, Standards & Calibration Curves
Application Guide

Analytical Samples and Standards

Collection of technical documentation to effectively limit interferences.

Application Guide

Sample Prep for Nucleic Acid Techniques

Contamination Under Control for Reproducible Amplification

Application Guide

QC Bioassays & Serial Dilutions

Collection of technical documentation for safe cultures and minimal variances

application guide thumbnail
Application Guide

Preparation of Buffer, Media and Microbio Testing

Ergonomic Preparation to Prevent Cross-Contamination

Application Guide

Fundamental PreAnalytics for Compliant Flexibility

Lab essentials for tailored sample preparation

cell line development ebook thumbnail
eBook

Lab Essentials for Successful Cell Line Development

Streamline routine CLD tasks, achieve more accurate results, avoid contamination, and simplify workflows.

infographic thumbnail
Infographic

Sample Preparation for Quality Control

Download this infographic to learn four ways to immediately improve the quality of your samples for common QC assays.

Why Ultrapure Water is Essential for Reproducible Endotoxin Results
Article

Why Ultrapure Water is Essential for Reproducible Endotoxin Results

Explore what type of ultrapure water is suitable for use in endotoxin analysis and how to validate and verify it is endotoxin-free.

Ultrapure water for HPLC analysis application note
Application Note

Ultrapure Water for HPLC Analysis - The Role of Ultrapure Water

HPLC is an analytical procedure for separation, identification and quantification of substances using liquid chromatography.

Application Note

Impact of the Claristep® Filtration System

On Recovery and Adsorption of Various Therapeutic Proteins at Low Sample Volumes

application note cover
Application Note

Are You GLP/GMP Compliant When It Comes to Pipetting?

Are you following methods for current Good Laboratory Practice (cGLP) or current Good Manufacturing Practice (cGMP)? 

flyer thumbnail
Flyer

Minisart® Syringe Filters for HPLC Sample Preparation

See how Sartorius Minisart® PP filters reliably remove particles from your samples without adding unwanted extractables or leachables.

brochure thumbnail
Brochure

Sample Preparation for Quality Control: Solutions for Optimized Workfl...

PDF 5.3 MB
Infographic

The Essentials of Sample Preparation Infographic

Sample preparation plays a key role in advanced techniques like chromatography, mass spectrometry, nucleic acid methods, and flow cytometry.

Interview

The Importance of Sample Preparation and Filtration

An interview with Stephanie Schweizer

Pharma Compliance & Regulatory Applications

eBook

Securing Accuracy in Pharma QC

The Strategic Role of Advanced Lab Balances

Scientist using Ingenix Suite software for lab data and fleet management.
Infographic

Ensuring Data Integrity: Connected Solutions

Explore this infographic to understand the importance of data integrity, the FDA’s focus on data integrity violations.

Webinar

Mastering Data Integrity with High-Precision Lab Balances & Associ...

Explore the essentials of maintaining data integrity in laboratory settings.

Sartorius Lab Essential portfolio for ISO 8655
Video

Sartorius Lab Essentials (LE) Portfolio

ISO 8655 Compliance for Pipetting

Pipette Calibration Lab Balance Software Application Image
eBook

Improved Pipette Calibration and Testing

Revisions in ISO 8655 Advance Laboratory Excellence

Picus-2 Single Channel 300-µL Pippette on a stand
Interview

The Importance of Pipette Calibration

Impacts of the New ISO 8655:2022 Standard

thumbnail
Product Guide

Pipette Calibration with Confidence

Designed to help you choose the best Sartorius option for your needs.

document thumbnail
Article

Achieving Excellence in Pipette Calibration

Learn more about the updates to ISO 8655:2022 for pipette calibration.

eBook

Pipette Calibration Matters: Comply with ISO 8655

As pipettes touch virtually every experiment, they influence the accuracy and repeatability of the experimental data.

Yellow rocket taking off from a laptop, startup and technology concept, black background.
Webinar

You're Now Connected: Prepare Your Lab for the Future

This webinar will explore the crucial roles of data integrity and laboratory connectivity in the lab.

Lock on circuit pattern. Concept of data security and cybersecurity. AI generated
Infographic

Data Integrity in Pharmaceutical Quality Control

This infographic provides an overview of key terms and definitions, points of compliance, and ways to achieve quality control and data integrity.

top tips thumbnail
Article

Top Tips for Navigating ISO 8655:2022 for Reliable Pipetting

Master precision by exploring the implications of the ISO 8655:2022 standard, its most important changes and their impact on pipette users.

brochure thumbnail
Brochure

Sample Preparation for Quality Control: Solutions for Optimized Workfl...

PDF 5.3 MB
Technical Note

Lab Weighing: Generic Operating Procedures for Routine Testing

Our series of Generic Operating Procedures provides valuable information about routine testing of lab balances. Discover more!

Inspecting Cubis instrument
White Paper

Best Practices Guide: Lab Weighing

Discover practical guidance on weighing in the lab, including calibration, accreditation, legal metrology and correct weighing.

Use of Laboratory Balances in the Pharmaceutical Industry cover
White Paper

Use of Laboratory Balances in the Pharmaceutical Industry

Our white paper summarizes USP Chapters <41> and <1251> and the new European Pharmacopoeia Chapter 2.1.7.

Pharmacopoeia Compliance Guide: Chapter 2.1.7 Ph.Eur. 

Ensure compliance with the updated European Pharmacopoeia guidelines and how the Cubis® II laboratory balance supports this.

Performance Test According to USP Chapter <41>

Generic operating procedure for a performance test according to chapter <41> of the United States Pharmacopeia (USP).

instrument services brochure cover

Sartorius Instrument Services - Ensuring Compliance, Reproducibility a...

PDF 683.0 KB
Infographic

ISO 8655:2022 Part 10

How to Achieve Pipetting Compliance

Modalities

Webinar

Advancing Sustainability in the Lab

Explore our range of eco-friendly lab products for tomorrow's science.

Flyer

Quality Control in the Vaccine Manufacturing Process

The recent pandemic demonstrated the need for rapid and safe global vaccine production. Explore the key points of vaccine quality control!

Editorial

Addressing the Challenges of QC Labs in Vaccine Manufacturing

In cell culture-based vaccine manufacturing processes, microbial contamination control and impurity testing are crucial elements of quality control.

cell based therapies thumbnail

Digital Tool: Cell-Based Therapies - Be on the Safe Side

Get QC Results for Advanced Therapy Medicinal Products (ATMPs) Before Treatment

Poster

Pharmaceutical Analysis for Small Molecules

Discover the most important techniques used for the characterization of drug products, the parameters to be considered during lab balances qualificati...

Brochure

Brochure: Quality Control of Monoclonal Antibody Production Process

PDF 743.8 KB

Cell Line Development Infographic

PDF 115.2 KB

Quality Control of Viral Vaccine and Viral Vector Production

PDF 726.5 KB
Brochure

Solutions for Medical Device Development, Manufacturing and Quality Co...

PDF 5.6 MB
Brochure

Innovative Solutions for Efficient and Simplified Chemical Analysis

PDF 3.7 MB

Sustainable QC Lab Products

Technical Note

iJust Software: Optimizing Water Quality for Sustainable Practices

Optifit Pipette Tip Refill Tower 350 µL with ACT Label
Products

Sustainability & Pipette Tips. Better Research, Better Results

Infographic

Preparing for the Future with Sustainable Lab Balances

Related Pharmaceutical QC Content

Analytical QC Lab

Quality Control Solutions for Regulated Laboratories

Innovative QC instruments and consumables for microbiological, physicochemical, and biological analyses, supporting accurate and reliable results.

Cubis® II: The 100% Configurable Laboratory Balance

A high-performance balance that will align with your unique demands and compliance requirements.