QC Corner | American Pharmaceutical Review - The Review of American Pharmaceutical Business & Technology

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.

Upgrade to LIMS 4.0 - Your Strategic Partner for the Lab of The Future

In this solution brief, you will uncover how CaliberLIMS adds value and optimizes your laboratory ... read more
The Role of Water Purification in Pharmaceutical QC: Ensuring Accurate Analysis

This Q&A aims to explore the crucial role of water purification in pharmaceutical QC labs. read more
USP 86: Bacterial Endotoxins Testing Using Recombinant Reagents

This video covers the impact of the adoption of rCR for product testing, how potential hurdles can ... read more
The Future of Endotoxin Testing: USP Chapter 86 and the Shift to Recombinant ...

This white paper covers an overview of USP Chapter <86>, the advantages of recombinant ... read more
Lab Balances in QC Labs

Watch this video to learn more about the solutions offered by Sartorius that will help you achieve ... read more
Moving Towards Sustainable BET Testing

Download this video to learn how you can meet the demands of supply security while protecting a ... read more
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 ... read more
Protein Tagging Strategies for Analytical and Preparative Purifications

When proteins are overexpressed in cells for studying these proteins either within the cellular host... read more
BIOFIRE® Mycoplasma system

Jeremy Robertson
In this webinar you will learn how you can maximize operational efficiency and save costs with 1-... read more
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 ... read more
Affinity Approaches to Selective, Sensitive MS Assays

Use of antibodies for detection of very low analyte concentrations has been evolving since Yalow and... read more
Middle-Up Strategies for Monoclonal Antibodies

Thorough characterization of protein therapeutics is essential to ensure that drugs developed and ... read more
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 ... read more
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... read more
QC Corner: Quality Control in Pharmaceutical Development

Bikash Chatterjee, Chief Operating and Science Officer at Pharmatech Associates discusses quality ... read more
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 ... read more
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, ... read more

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Overcoming Sterility Testing Bottlenecks in Cell Therapy Manufacturing

Learn how rapid sterility testing can address the limitations of traditional sterility testing. read more
Unlocking Productivity: How Advanced Technologies Are Transforming Microbial ...

Pharmaceutical manufacturers are facing a perfect storm of challenges. Aging populations in advanced... read more
Culture Media Considerations for Compliant Aseptic Process Simulations

Aseptic process simulation (APS) is a critical periodic test that manufacturers of aseptically ... read more
How to Ensure Data Integrity When Digitalizing Your Microbial QC Lab Step by ...

The vast majority of pharmaceutical manufacturers are currently in the process of digitalizing their... read more
Improve Your Microbial QC Testing Efficiency

This webinar reviews challenges of traditional workflows for microbial QC strains, discusses the ... read more
Minimizing the Risk of Contamination and False Results in Bioburden Testing

Reliable microbial test results are pivotal for quality control laboratories. False positives ... read more
As Prototypes Are Refined into Standardized Solutions, It Is Time to Consider ...

At a time when the pharmaceutical industry is entering a new transformational phase, the promise ... read more
Streamlining Environmental Monitoring: A CMO’s Success with 3P^® ENTERPRISE...

This case study explores Selkirk’s journey with 3P^® ENTERPRISE. Download now to learn how it ... read more
Disinfect, Autoclave or Use Multiple-Bagged Disposables? Moving Materials into ...

Transferring equipment into and out of cleanrooms and critical zones has proven to be one of the ... read more
Co-Processed Excipients for Self-Emulsifying Drug Delivery Systems

Learn how a formulators can benefit from an emulsion preconcentrate kit, and about the advantages, ... read more
The Many Ways How Digitalization Is Improving Sterility Testing

Do you know what percentage of citations in post-inspection, FDA Warning Letters relate to ... read more
Sterility Testing Workflow Solutions

Watch this webinar to learn more about the importance of sterility testing and compliance, as well ... read more
How Decades of Firm Belief in Ever More Reliable Sterility Testing Serve as ...

An entrepreneur can have a lasting influence on a company, and this has been the case with Jack Bush... read more
Enhanced Cleanroom Control: Modern Methods for Accurate Mold Detection

In this webinar, hear from Dr. Doug Botkin from Charles River Laboratories as he discusses Enhanced ... read more
Using Rapid Microbiological Methods Flexibly to Ensure Safe Cell and Gene ...

Testing short-life cell and gene therapeutics for microbiological contamination is a challenge ... read more
Critical Considerations in Validating Alternative Mycoplasma Detection Methods

This video introduces critical considerations in validating an alternative method, and demonstrates ... read more
Increasing Pharmaceutical Quality Control with Automation

How can automation improve your QC? This white paper explores the future of QC and automation. ... read more
Why It’s Time to Implement a Digital Management System for Environmental ...

Microbiological environmental monitoring (EM) can be complex, generating hundreds or even thousands ... read more
Rapid Sterility Testing for Cell and Gene Therapy Treatments

Every day counts for manufacturers of short-shelf-life biologics/treatments who need to release ... read more
QC Corner: Environmental Monitoring: Expert Discussion on the Benefits of a ...

Thierry Bonnevay Laurent Leblanc
The Environmental Monitoring program is an important quality control for the pharmaceutical ... read more
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, ... read more
The Intricacies of Testing for Mycoplasmas in Cell Culture Systems

Mycoplasma contamination is a widespread and reoccurring problem in many cell and tissue culture ... read more
QC Corner: Automated Methods for Environmental Control (EM)

Heavy investments across the entire bioproduction value chain – from R&D to industrialization and ... read more
QC Corner: Automated Data Integrity in Sterility Testing

Pharma 4.0 transformation processes are reaching microbiological QC labs, using automation, robotics... read more
Whitepaper: Key Considerations for Extracting Proteins from Recombinant Host ...

In the biopharmaceutical industry, quality is pivotal. For a final product to meet quality standards... read more
Whitepaper: Purification Strategies for Recombinant Therapeutic Proteins

Many biopharmaceuticals are recombinant proteins obtained by biotechnological processes. In various ... read more
Robotics and Automation: The Future of Pharma QC

Watch Now! The pharmaceutical industry is evolving towards automated, intensified and real-time-... read more

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The Use of Mycoplasma Reference Standards in the Light of ...

On 1 April this year, the Ph. Eur. Chapter 2.6.7, in its thoroughly revised form, came into force. ... read more
Should You Implement Continuous Real-Time Microbial Air ...

When properly integrated through appropriate design planning, validation and alignment with ... read more
Ensuring Data Integrity and Compliance with Viable Samplers...

In the pharmaceutical industry, ensuring the quality and safety of products is paramount. As part of... read more
Microbiological Testing: The Silent Guardian of ...

Download now to learn more importance of adopting modern microbiological methods and robust quality ... read more
Goodbye Rabbit, Hello MAT: The Start of a New Era in Pyrogen...

In June 2024, the European Pharmacopoeia Commission adopted 57 revised monographs from which the ... read more
Enhancing Material and Equipment Availability in Production...

Using isolators for aseptic processing is fast becoming standard practice in the pharmaceutical ... read more
Increase Control and Productivity of CDS for Pharmaceutical ...

Learn how to increase productivity with a CDS thru workflow automations, real-time monitoring, ... read more
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 ... read more
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 ... read more
Two Strategies to Improve the Productivity and Compliance of...

As the pharmaceutical industry enters a new transformational phase, there is immense potential for ... read more
FDA 483s and Non-Compliance in Pharma

Download this white paper to learn more about FDA 483’s, drug production, compliance and QC. read more
QC Corner: Recent Updates to Guidances Help Standardize ...

Risk assessment for extractables and leachables (E&L) contained in polymeric manufacturing ... read more
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 ... read more

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