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QC
Corner
Discover new trends, technologies and solutions for your most pressing quality control concerns through our QC Corner.
Covering topics from drug development, to manufacturing, and regulatory guidance, our QC Corner features a variety of content from industry thought leaders, consultants, regulatory agencies and industry suppliers. QC Corner offers content through a mix of articles, webinars, and videos all specifically chosen to increase your knowledge and understanding of the latest strategies for pharmaceutical quality control and assurance.
Development
Moves to Replace Animal-Based Detection of Pyrogens By In-Vitro Testing
Driven by the 3Rs principle to replace, reduce and refine the use of animals in the testing of ...
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Protein Tagging Strategies for Analytical and Preparative Purifications
When proteins are overexpressed in cells for studying these proteins either within the cellular host...
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On-Demand Webinar: Ensure your Pipetting is QC Compliant
Joni Åke
Axel Taube
In this webinar, Joni Åke, Product Manager at Sartorius, and Axel Taube, Service Product Manager at ...
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BIOFIRE® Mycoplasma system
Jeremy Robertson
In this webinar you will learn how you can maximize operational efficiency and save costs with 1-...
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Developing Cysteine Protease Inhibitors for Therapies Against SARS-CoV-2
SARS-CoV-2, the virus responsible for the global COVID-19 pandemic, has caused millions of ...
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Affinity Approaches to Selective, Sensitive MS Assays
Use of antibodies for detection of very low analyte concentrations has been evolving since Yalow and...
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Middle-Up Strategies for Monoclonal Antibodies
Thorough characterization of protein therapeutics is essential to ensure that drugs developed and ...
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Whitepaper: QC Executive Q&A - Research and Development of Protein-Based ...
As a global provider, MilliporeSigma offers a wide range of products and services to biopharma. On ...
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QC Corner: Single-Use Systems Underline the Rising Significance of Extractables ...
Examining extractables and leachables is an important safety issue as these substances can adversely...
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QC Corner: Quality Control in Pharmaceutical Development
Bikash Chatterjee, Chief Operating and Science Officer at Pharmatech Associates discusses quality ...
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Perfusion Medium Development for Continuous Bioprocessing of Animal Cell ...
Patrick Mayrhofer
Renate Kunert
Traditional bioprocesses of mammalian cell cultures are operated in batch- or fed-batch mode. To ...
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The Human Microbiome: What It Is, Why It Is Important and Opportunities for ...
Dr. Clare Trippett
The human body is home to a huge and diverse community of microorganisms, consisting of bacteria, ...
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Manufacturing
Critical Considerations in Validating Alternative Mycoplasma Detection Methods
This video introduces critical considerations in validating an alternative method, and demonstrates ...
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Increasing Pharmaceutical Quality Control with Automation
How can automation improve your QC? This white paper explores the future of QC and automation. ...
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Why It’s Time to Implement a Digital Management System for Environmental ...
Microbiological environmental monitoring (EM) can be complex, generating hundreds or even thousands ...
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Rapid Sterility Testing for Cell and Gene Therapy Treatments
Every day counts for manufacturers of short-shelf-life biologics/treatments who need to release ...
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QC Corner: Environmental Monitoring: Expert Discussion on the Benefits of a ...
Thierry Bonnevay
Laurent Leblanc
QC Corner: Environmental Monitoring: expert discussion on the benefits of a single incubation ...
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The Intricacies of Testing for Mycoplasmas in Cell Culture Systems
Mycoplasma contamination is a widespread and reoccurring problem in many cell and tissue culture ...
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QC Corner: Water Needs in Pharma Quality Control
This guide covers challenges faced in Pharma QC such as ensuring water in QC labs is compliant, ...
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QC Corner: Automated Methods for Environmental Control (EM)
Heavy investments across the entire bioproduction value chain – from R&D to industrialization and ...
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QC Corner: Automated Data Integrity in Sterility Testing
Pharma 4.0 transformation processes are reaching microbiological QC labs, using automation, robotics...
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Clean Label Podcast with Ken Seufert
Ken Seufert
Join Ken Seufert, JRS Pharma Chief Executive Officer, and Mike Auerbach, American Pharmaceutical ...
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Whitepaper: Comprehensive Pure Water Guide for Pharmaceutical Engineers
In today’s pharmaceutical facilities the availability of purified water is essential. While the ...
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QC Corner: Environmental Monitoring as a Component of a Contamination Control ...
Mark Hallworth
Watch Now! In this webinar, Mark Hallworth discusses environmental monitoring as a component of a ...
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Robotics and Automation: The Future of Pharma QC
Watch Now! The pharmaceutical industry is evolving towards automated, intensified and real-time-...
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Whitepaper: Key Considerations for Extracting Proteins from Recombinant Host ...
In the biopharmaceutical industry, quality is pivotal. For a final product to meet quality standards...
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Whitepaper: Purification Strategies for Recombinant Therapeutic Proteins
Many biopharmaceuticals are recombinant proteins obtained by biotechnological processes. In various ...
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QC Corner: Improved Pharmaceutical Quality Control through Updated Monograph ...
Monographs and general chapters that provide public quality standards for drugs, excipients, and ...
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BIOBALL®
Burkholderia cepacia
Complex Strains Performance Testing for USP <60> 60>...
The purpose of this paper was to evaluate BIOBALL® MultiShot 550 Bcc range recovery levels on ...
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On-Demand Webinar: Bio-fluorescent Particle Counters: Continuous Monitoring ...
Allison Scott, PhD
Webinar provides an overview of why continuous monitoring of water systems is needed to ensure the ...
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An Interview with MilliporeSigma
Viral vaccines contain either inactivated or attenuated viruses with the aim of inducing a ...
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QC Corner: Plasma Protein Binding Studies: Equilibrium Dialysis or Solid-Phase ...
Bioavailability is a key attribute of lead compounds and drug candidates. Usually only a fraction of...
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QC Corner: When, Why and How to change vendors for QC testing solutions
Marie France Quillen
QC Corner: When, Why and How to change vendors for QC testing solutions
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On-Demand Webinar: Quality Control in the Next Normal
On-Demand Webinar: Quality Control in the Next Normal
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Watch Webinar: Bio-fluorescent Particle Counters: Enhancing Your Understanding ...
Allison Scott, PhD
Watch Webinar: Bio-fluorescent Particle Counters: Enhancing Your Understanding of Process Water
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QC Corner: Particle Detection & Identification in Parenteral Products
Robin Sweeney, Product Manager at Unchained Labs joins Editor-in-Chief Mike Auerbach to discuss ...
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Horseshoe Crab Sustainability Project
In this poster video, Brett Hoffmeister, the LAL Production Manager from the Associates of Cape Cod ...
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QC Corner: The Intersection of Development and Manufacturing
QC Corner: The Intersection of Development and Manufacturing
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QC Corner: Large Molecule Manufacturing Technologies
Trends and advances in manufacturing of large molecules are discussed in this chat with HDR Company'...
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Filing a Multistage Continuous Process for API
Malcolm B. Berry, PhD
In recent decades, the pharmaceutical industry has witnessed a revolution in the regulatory ...
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Effect of binder particle size on tablet performance
Binders play a crucial role in ensuring acceptable tablet hardness and low friability in direct ...
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Regulatory
Enhancing Material and Equipment Availability in Production...
Using isolators for aseptic processing is fast becoming standard practice in the pharmaceutical ...
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Increase Control and Productivity of CDS for Pharmaceutical ...
Learn how to increase productivity with a CDS thru workflow automations, real-time monitoring, ...
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New Regulation to Reduce Contamination Risks in Sterile ...
Both PDA TR 90 and the European Union’s recently revised GMP Annex 1 require manufacturers of ...
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Two Strategies to Improve the Productivity and Compliance of...
As the pharmaceutical industry enters a new transformational phase, there is immense potential for ...
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Designing an Environmental Monitoring Solution for GMP
In light of the recent update of the EU GMP Annex 1 in 2022, it has become imperative to reassess ...
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Effective Contamination Control Strategy and Microbial ID ...
Christian Scheuermann
What is an effective contamination control strategy, microbial ID methodology? This video goes in-...
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FDA 483s and Non-Compliance in Pharma
Download this white paper to learn more about FDA 483’s, drug production, compliance and QC.
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Watch Now!
Brice Chasey
In this on-demand webinar, Brice Chasey, Associate Director of Product Management at Charles River ...
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QC Corner: Recent Updates to Guidances Help Standardize ...
Risk assessment for extractables and leachables (E&L) contained in polymeric manufacturing ...
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QC Corner: How the 2020 draft EU GMP Annex 1 changes will ...
EU GMP Annex 1, which regulates the manufacturing, control and release of sterile pharmaceutical ...
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