Blog

Updated on Nov 17, 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 …

Published on Oct 30, 2023 By Jason Ellis, PhD Share

Clonal expansion is the process of rapid cell division resulting in the multiplication of genetically identical cell clones from a single parent cell. This exponential growth provides a robust concentration of specific genetic material that aids immune and developmental processes. Clonal expansion replaces damaged or worn tissues and old cells with new ones, healing wounds and aiding growth. In very early embryonic stages, cell expansion provides a rapid supply of …

Published on Oct 5, 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 …

Updated on Aug 7, 2024 By Dominique Badea, PhD Share

Leukopaks are an essential tool across medical and research applications, providing a robust source of white blood cells in a much higher concentration than whole blood samples. A leukopak is an enriched apheresis product collected via leukapheresis. During the leukapheresis process, white blood cells are collected and enriched by the simultaneous return of non-target blood cells to circulation. They contain a high concentration of peripheral blood mononuclear cells (PBMCs). As …

Updated on Aug 7, 2024 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 …

Updated on Aug 13, 2024 Share

Protecting cells during cell processing is a critical aspect of protocol design and development. Cells are fragile by nature, requiring specific and gentle handling to survive and optimally perform in their downstream applications. Some cells are more delicate than others and more prone to damage or cell death when exposed to stressful conditions. The Importance of Gentle Handling Handling cells gently is crucial to maintaining cell viability, morphology, and experimental …

Published on Aug 22, 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, …

Updated on Aug 22, 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 …

Updated on Sep 25, 2024 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 …

Updated on Aug 7, 2024 Share

Sample processing techniques like cell separation can potentially damage cells of interest and even decrease cell viability. Removing these dead cells before further clinical or research testing is important to reducing confounding downstream testing and results.  In the case of leukopak processing, dead cell removal remains an integral step in preparing pure and high-quality cell populations. If dead cells are not properly removed from a sample, they can release toxins …