Antibody reagents for your host cell protein assay: Experience counts

In the world of biopharmaceuticals and bioprocessing, ensuring the quality, safety, and efficacy of biotherapeutic products is of paramount importance. Host cell proteins (HCPs) are a critical component to consider in this context. HCPs are proteins of the host cells, typically microbial, insect or mammalian, used in the manufacturing of biologics, such as monoclonal antibodies, recombinant proteins, and vaccines. These HCPs originate from a variety of cellular sources, including the cell membrane, cytoplasm, nucleus, mitochondria, and other cellular compartments.

Bioanalysis of Biologics: Understanding the Role of LC-MS

As biologics-based therapies have expanded, LC-MS is increasingly applied to support quantitative bioanalysis to detect diverse peptides and proteins. LC-MS can offer a few notable advantages compared to the traditional approach for quantification with ligand-binding assays (LBAs), but is typically thought of as a complementary approach.

Decentralized Clinical Trials (DCT) Monthly Blog – December 2020

Welcome to the December edition of the DCT blog. In our final edition for 2020, we look back on an eventful year.

IND-enabling Programs for Gene and Cell Therapies Webinar Questions

Get insightful answers to some common questions on IND-enabling studies for cell and gene therapies (CGTs) from our recent presentation. For more information on our solutions, visit our Cell & Gene Therapy Education Center here.

The importance of bees in crop pollination

Pollinator protection is a hot topic at the moment, and deservedly so. In order to feed a global population of 7.7 billion people, we must control unwanted pests that damage food crops, without killing the insects that help produce the food; this predominantly means bees. Various claims are purported as to the proportion of our food that derives from bee pollination, whether that is 30% or 50% or 90% it is largely immaterial; the key consideration is that bees must be protected along with the food source.

Evolving drug trends and spotlight on xylazine

During this webinar, our toxicology experts provide an informative and fascinating review of the ever-changing landscape of the illicit drug market. Labcorp’s R&D scientific director shares insights related to the history of designer drugs, new uses for age-old drugs and how Labcorp responds to evolving drug trends. Most importantly we discuss the relevance of these drug trends in routine clinical practice.

Centralized multiple myeloma service delivers on a global scale

As the volume of multiple myeloma clinical trials continues to grow, additional tests are being validated in an effort to benefit patients who typically have a five-year survival rate. These dynamics are driving strategies to address variability in testing procedures and data analysis. We recently met with our dedicated Multiple Myeloma Team to learn more.

Decentralized Clinical Trials (DCT) Monthly Blog – January 2021

In the aftermath of a turbulent 2020, in which the overall industry perception of the decentralized clinical trial (DCT) approach transitioned from being “promising but still largely experimental” to “a new-normal paradigm for the industry to adopt,” we have been considering “what’s next?”

Potency Assays 101: How to Develop a CMC Relative Potency Assay eBook

The Relative Potency Assay for a typical biologic is usually the most complex assay in the release and stability specification. Relative Potency methods should be designed to be as simple as possible but should still reflect the mechanism of action (MOA) that is linked to the relevant biological properties of the molecule, as is required in the regulations. The more steps in an assay presents more opportunity for variation and the less precise the ultimate result may be. In some cases, multiple potency assays may be required if there are multiple MOAs of a molecule or if a full understanding of the relevant biological properties is not fully understood, as might be the case with complex cellular therapeutics.