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Big Picture

An exclusive digital series focusing on the most crucial topics and issues facing today’s laboratory professionals

5-Part Series

Published Apr 13, 2022

Develop a Smart HCP Kit Strategy

Host cell proteins (HCPs) are process-related impurities that are produced by the host organism during biologic manufacturing and production. A purification process is necessary to reduce the levels of HCPs in any biopharmaceutical product to ensure it is safe for patients. Analysis techniques like the enzyme-linked immunosorbent assay (ELISA) are conducted to quantify the remaining levels of HCPs after purification. This is a complex process that requires the right tools, expertise, and strategies. This series explains the process of HCP analysis in biologics development, the benefits of using ELISA kits, how to ensure security of supply for HCP reagents, and solutions for validating HCP ELISAs.  

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Articles in this Series
Host Cell Protein Analysis in Biologics Development ELISA: The Benchmark HCP Assay Ensuring the Security of Supply for HCP Reagents for Drug Process Development and Manufacturing Challenges and Solutions for Validating HCP ELISAs Future-Proof Your HCP Strategy

Develop a Smart HCP Kit Strategy

Develop a Smart HCP Kit Strategy

Host cell proteins (HCPs) are process-related impurities that are produced by the host organism during biologic manufacturing and production. A purification process is necessary to reduce the levels of HCPs in any biopharmaceutical product to ensure it is safe for patients. Analysis techniques like the enzyme-linked immunosorbent assay (ELISA) are conducted to quantify the remaining levels of HCPs after purification. This is a complex process that requires the right tools, expertise, and strategies. This series explains the process of HCP analysis in biologics development, the benefits of using ELISA kits, how to ensure security of supply for HCP reagents, and solutions for validating HCP ELISAs.  

Host cell proteins (HCPs) are process-related impurities that are produced by the host organism during biologic manufacturing and production. A purification process is necessary to reduce the levels of HCPs in any biopharmaceutical product to ensure it is safe for patients. Analysis techniques like the enzyme-linked immunosorbent assay (ELISA) are conducted to quantify the remaining levels of HCPs after purification. This is a complex process that requires the right tools, expertise, and strategies. This series explains the process of HCP analysis in biologics development, the benefits of using ELISA kits, how to ensure security of supply for HCP reagents, and solutions for validating HCP ELISAs.  

Female lab leader with lab coat and gloves in lab, looking at camera smiling

How to Become a Lab Manager

Lab managers often enter into the role without any formal leadership or management training, causing them to learn on the go, by trial and error. But becoming an effective, trusted lab manager is a complex challenge that requires the development of a diverse set of skills and knowledge. This series explains the different stages of lab management, provides aspiring leaders with resources and tips to help them better prepare for a higher-level role, and shares key traits and qualities of effective managers. 

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grocery items

The Latest in Food Safety and Testing

The food safety and testing industry is booming with new innovations. These developments help to ensure that everything on our dining tables—from the orange juice we drink in the morning to the vegetables on our dinner plates—are safe, authentic, and of good quality. In this series, we discuss some of the latest advances in food safety testing and technology, as well as the challenges of detecting food fraud, and the important role filtration plays in ensuring food quality.

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A cannabis bud is held by a pair of tweezers in preparation for testing.

Ensuring Quality in Cannabis & Hemp Testing

With everchanging or non-existent regulations and standards, achieving quality and consistency has been a challenge for US cannabis and hemp testing labs. However, recent signals indicate that various industry stakeholders are slowly achieving consensus on such oversight, meaning better, more accurate test results. We explore recent trends in the industry, the keys to starting a successful testing lab, and what to consider when doing proficiency testing or getting your cannabis or hemp lab certified.

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A female scientist and male colleague stand on either side of a giant checklist as they choose lab services to outsource.

Key Considerations for Outsourcing Laboratory Services

Is outsourcing right for your lab? What services are available and which are the best choice for your facility? How do you determine which contract lab or service provider is the right one to outsource your lab’s work to? Get the answers to these questions and more in our series on laboratory services outsourcing.

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A female laboratory worker uses the touchscreen of a piece of equipment in the laboratory.

Asset Management for the Lab: Strategies and Tips

Managing the purchase, use, and maintenance of laboratory equipment is a significant undertaking for any lab manager. Each phase of an instrument’s life cycle requires investment, informed decision making, and pre-planning. This web series guides readers through the various stages of asset management—from buying new (or used) equipment and navigating service contracts to maximizing equipment life cycles and finding new uses for unneeded instruments and tools.

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new-lab-setup

Managing a New Lab Setup

Whether creating a new lab facility from scratch or moving your existing lab to a new space, the process of setting up a working laboratory is a complex process. Depending on the equipment and other needs of your lab, it can take weeks after the initial move-in day to get fully operational. In this web series, we offer tips and solutions to some of the main hurdles of leading a new lab setup.

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The Main Stages of Pharmaceutical Discovery and Development

Pharmaceutical Development: Solutions for Each Stage

At each stage of the drug discovery, development, and approval process, there are many aspects to consider and many details to get right. To bring most drugs from discovery in the lab to approval for sale in the pharmacy requires roughly 10 years and can cost billions of dollars. In this web series, we explore some of the solutions to key challenges in each of the main stages of pharmaceutical discovery and development.  

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Analytical Testing Drives Production of Lithium-Ion Batteries

Analytical Testing Drives Production of Lithium-Ion Batteries

Lithium (Li)-ion batteries are crucial power sources for a wide variety of important consumer products like electric vehicles, phones, and computers. The production of high quality Li-ion batteries (LIB) requires high purity components, especially the Li. High performance analytical instruments and techniques can help deliver these high purity components.  This series explores different aspects of analytical testing and key technologies that improve analysis from the mining and refining of the Li, through the manufacture and recycling of the LIB cells.  

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Testing for Contaminants in Environmental Samples

Testing for Contaminants in Environmental Samples

Environmental samples—soil, water, air, and wastes—pose unique challenges for collection, transport, and analysis. Many contaminants are present in very low concentrations, and require sensitive methods and instruments for detection. Specific applications—especially wastewater testing—require rapid, efficient testing. This series explores different aspects of environmental testing and key technologies that improve analysis.

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A Brief Overview of Bioprocessing

Bioprocessing: Where It Is and Where It's Going

Bioprocessing involves the creation of a needed material from a living organism, usually cells or parts of cells, with applications in food and biofuel production, medicines, or therapies, to name a few. In this Big Picture series of articles, we’ll provide a brief overview of bioprocessing and bioprocess engineering with a particular focus on bioprocessing for therapeutics, as well as a more in-depth look at some of the ways companies are solving challenges in industrial bioprocessing, trends in single-use bioprocessing, recent developments in cell line development in upstream bioprocessing, and how new options in cell media can help overcome the challenges of cell therapy manufacturing.

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What We Have Learned About Managing a Lab during a Pandemic

Lab Management in the COVID-19 Era: 1 Year Later

Though they faced sudden, massive change when the pandemic was declared in March 2020, lab professionals have risen to the challenge. Battling mental health stresses, communication issues, remote work, increased workloads, and changes to workflows, in addition to a host of other issues, lab managers and their teams are emerging from the pandemic stronger than ever. In this series, we cover key crisis management lessons learned from a year of managing a lab during the COVID-19 pandemic.

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Best Practices for Lab Data Integrity and Security (article image)

Data Integrity and Cybersecurity in Today’s Labs

Laboratory leaders use diverse sets of data on a daily basis, from data generated by basic research experiments, to analyzing financial data to make informed business decisions. Regardless of the type of data being produced and analyzed in a lab, it must be trustworthy and accurate. Ensuring data integrity and security promotes a positive lab culture, protects the lab’s reputation, and drives business growth.

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