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October 2023 By Jason Ellis, PhD Share

A contract development and manufacturing organization (CDMO) is a business that provides drug development and manufacturing services to support product research, idea development, and production. New companies entering the medical or biotechnology space will face many regulatory hurdles before new products are ready for launch; and larger, more long-standing companies sometimes need additional manufacturing bandwidth. CDMOs manage multiple aspects of the product development process and guide companies through regulatory requirements …

October 2023 By Jason Xu, PhD Share

Numerous discovery, development, and research stages exist before a new drug, pharmaceutical treatment, or medical device hits the market. Each of these stages brings unique challenges, and success depends heavily on the resources available to the sponsor of the novel treatment. Contract research organizations (CROs) provide specialized research, such as preclinical research, clinical trials, and a range of other research-based offerings, for biotechnology, pharmaceutical, and medical device companies on a …

October 2023 By Jason Ellis, PhD Share

Introduction to GMP in Biotech Biotechnology sales require adherence to rules and regulations that protect both the companies and patients involved. These practices are commonly referred to in the community as GMP or good manufacturing practices. In the United States, these regulations are enacted and enforced by the Food and Drug Administration (FDA) to ensure product quality and safety. Also referred to as cGMP or current good manufacturing practices, they …

August 2023 Share

What Is Dead Cell Removal? Dead cell removal involves removing dead cells and debris from a culture or cell population to enhance purity and viability. Researchers and clinicians utilize this process in various research and clinical applications, including cell culturing, sorting, manufacturing, and cellular assays like flow cytometry. How Is Dead Cell Removal Used Across Applications? Cell culture experiments involve studying cells in a natural and controlled state. Over time, …

August 2023 Share

Dead cells naturally contaminate cell samples or cultures throughout their lifespan; this contamination can occur at any time. While common, dead cells and debris negatively affect cell populations before and after separation, isolation, and application. Removing dead cells and debris before further processing plays a critical role in culture maintenance and adherence to good laboratory practices. Cell Culturing and Dead Cells Researchers grow cell cultures in the laboratory that can …

June 2023 By Brandon H. McNaughton, PhD Share

What Is a Customized Leukopak? A leukopak is a blood product enriched with white blood cells obtained through a unique extraction technique, leukapheresis. Leukapheresis, a specialized application of apheresis, targets the collection of leukocytes and returns all non-leukocyte material to the donor’s bloodstream.  Leukopaks can be customized to fit the requirements of their intended application, both clinically and for research and development. Before leukopak collection, donors are strategically selected for …

June 2023 Share

Cell washing is a crucial technique used in both clinical and research settings for various biomedical applications. When trying to produce a pure, isolated population of cells via leukopak processing, cell washing is typically the first step. It removes unwanted cells and other contaminating material, such as proteins and platelets, leaving the apheresis product ready for high-precision cell separation. This enables the isolation of a pure population of cells, which …

October 2021 Share

Mouse B Cell Enrichment: How to Culture Isolated Mouse B Cells The primary function of B cells is antibody production. They are called B cells because they mature in the bone marrow, while T cells mature in the thymus. Receptors on the surface of a B cell bind to foreign antigens and develop antibodies that suppress that specific pathogen. Understanding more about how B cells work can provide insight into …

March 2021 Share

Researchers and scientists around the world have long theorized that the inherent directional systems in various animals (including migratory animals like birds, butterflies, whales, and possibly even humans) could have a magnetic component – that internal navigational impulses are related in some way to Earth’s magnetic field. While this has been a long-standing theory, the underlying cellular mechanisms that support the ability of an organism to detect magnetic field to …

March 2021 Share

Cell Dissociation Methods Research is undertaken step by step, and cutting corners provides inaccurate results. It’s important to follow proper protocol from beginning to end to ensure the highest quality findings possible. When working with cells of any kind (immune cells, tumor cells, etc.) the first step is always to collect the desired cell sample from the host tissue. Dissociation, sometimes called disaggregation, involves the breaking down of a cell …