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Updated on Apr 3, 2025 By Jason Ellis, PhD Share

Cancer continues to pose significant health challenges worldwide, affecting millions of patients each year. Its diverse forms and complexity often require a multifaceted treatment approach. Over the years, various therapeutic strategies have emerged, each bringing its own set of benefits and challenges. Among these strategies, adoptive cell therapy stands out as a promising approach. It involves the direct infusion of immune cells—primed and empowered to combat malignancies—back into the patient. …

Updated on Apr 7, 2025 By Jason Ellis, PhD Share

Good manufacturing practices (GMP)—are system that ensures products are consistently produced according to quality standards—is a concept most in the biotech industry are familiar with. But what exactly is clinical GMP? Clinical GMP specifically refers to the guidelines associated with products intended for human medical use. Unlike general GMP, which can pertain to various industries, clinical GMP focuses specifically on products intended for human consumption or application, ensuring that medical/medicinal …

Updated on Apr 7, 2025 By Jason Ellis, PhD Share

As modern medicine continues to advance, the battle against cancer is increasingly being fought on a cellular level—and CAR T cell therapy is at the vanguard. Chimeric antigen receptor (CAR) T therapy is a remarkable form of immunotherapy that harnesses the body’s cellular defenses. It has revolutionized the treatment of malignancies such as lymphoma and blood cancers. Yet, the success of this therapy relies on more than just the genetically …

Updated on Apr 7, 2025 By Jason Ellis, PhD Share

The emergence of CAR T cell therapies is one of the most promising developments in cancer treatment. This revolutionary approach, which involves reprogramming a patient’s own immune cells to fight cancer, has garnered significant attention and hope in the medical community. The recent approvals of adoptive cell therapies mark a new era in oncology and our understanding of the immune system, offering fresh avenues for patients battling various forms of …

Updated on Apr 7, 2025 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 …

Updated on Apr 7, 2025 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 Apr 7, 2025 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 Mar 28, 2025 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 Apr 7, 2025 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 …

Updated on Apr 2, 2025 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, …