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

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.

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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.

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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

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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.

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Article

Article: Bioburden Testing of Viscous Samples

How to Achieve Pharmacopeia-Compliant Bioburden Testing of Viscous Samples

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Flyer

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

PDF 976.4 KB

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Flyer

Rapid Sterility Solutions: Microsart^® ATMP Sterile Release

PDF 932.6 KB

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Flyer

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

PDF 815.3 KB

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Flyer

Rapid Solutions: Microsart^®️ ATMP Bacteria, Fungi and Mycoplasma

PDF 759.1 KB

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Poster

Detection of Nucleic Acid Traces

A PCR Kit Manufacturer Perspective

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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

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Application Note

Filtration of Viscous Samples for Microbiological Quality Control

The results of this study provide valuable insights into the most effective methods for microbial enumeration of viscous substances.

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Infographic

Solutions for Microbiological Quality Control

This infographic covers continuous air monitoring, isokinetic sampling and advantages of gelatine filters

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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.

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Application Note

Continuous Microbial Air Monitoring in Clean Room Environments

In this study, we qualify gelatin membranes manufactured by Sartorius for continuous air monitoring

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Application Note

Continuous Microbial Air Monitoring in Clean Room Environments

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

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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.

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Infographic

Microbiological QC Biopharma Production Process

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

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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...

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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.

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Brochure

Microbiological QC Solutions: Performance You Deserve, with the Compli...

PDF 4.5 MB

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Bioanalytical QC

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.

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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...

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Application Note

Biosimilar Assessment

Novel, High-Throughput Approach for Testing Development Samples

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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.

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Flyer

AAV Capsid Titer Data 80 Percent Faster Compared to ELISA

PDF 314.3 KB

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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

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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...

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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

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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.

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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.

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Application Note

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

PDF 372.5 KB

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Physiochemical QC

eBook

Lab Essentials for Successful Cell Line Development

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

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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.

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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.

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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.

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Application Note

Impact of the Claristep^® Filtration System

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

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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)?

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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.

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Brochure

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

PDF 5.3 MB

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Pharma Compliance & Regulatory Applications

Brochure

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

PDF 5.3 MB

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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!

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White Paper

Best Practices Guide: Lab Weighing

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

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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.

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Pharmacopoeia Compliance Guide: Chapter 2.1.7 Ph.Eur.

Download to ensure adherence to the updated European Pharmacopoeia guidelines and how our Cubis^® II laboratory balance supports this.

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Performance Test According to USP Chapter <41>

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

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

PDF 2.7 MB

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Modalities

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!

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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.

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

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

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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...

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