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What Is Clinical GMP?

Updated on Sep 5, 2025 | Published on Feb 16, 2024 By Jason Ellis, PhD

Female Scientist Working in a Lab, Using the Computer

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 …

Formula for Success: Preparing CAR T Cells for Infusion

Updated on Jun 10, 2025 | Published on Feb 15, 2024 By Jason Ellis, PhD

Scientists in a Lab Looking at Data on a Computer

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 …

Approved CAR T Cell Therapies Revolutionize Cancer Treatment

Updated on Jun 10, 2025 | Published on Feb 15, 2024 By Jason Ellis, PhD

Hands Holding Colorful Cancer Awareness Ribbons

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 …

Akadeum’s Brandon McNaughton to Present at Biotech Showcase 2024

Event Start Date: JAN 8, 2024

Biotech Showcase 2024 Logo

Join the Akadeum team in San Francisco on January 8-10, 2024 at the annual Biotech Showcase event. Recognized globally as a premier investor conference, Biotech Showcase 2024 promises to be a unique opportunity for small and mid-sized biotech companies to demonstrate their latest innovations and engage in face-to-face conversations with investors and biopharmaceutical executives.  Our very own Brandon McNaughton, CEO of Akadeum Life Sciences, will present the latest advancements in …

Akadeum at Advanced Therapies Week 2024 in Miami

Event Start Date: JAN 16, 2024

Advanced Therapies Week Logo

We are thrilled to announce that Akadeum Life Sciences will attend Advanced Therapies Week (ATW) 2024, January 16-19, 2024. Set in the vibrant heart of Miami Beach, the event promises to gather the brightest minds and leading organizations in biomedical therapies. It’s a pivotal platform for forming partnerships, sharing insights, and exploring the newest technologies. Our team is excited to contribute to the dynamic conversations that define this event. We …

What Is a CDMO?

Updated on Sep 7, 2025 | Published on Oct 30, 2023 By Jason Ellis, PhD

Two Technicians Analyzing Data on a Computer

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 …

What Is a Contract Research Organization?

Updated on Sep 5, 2025 | Published on Oct 5, 2023 By Jason Xu, PhD

Two Scientists in Lab Coats Looking at a Computer Screen

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 …

Understanding GMP Leukopaks

Updated on Sep 7, 2025 | Published on Oct 2, 2023 By Dominique Badea, PhD

Two scientists conducting an experiment while wearing protective gear.

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 …

Understanding GMP in Biotech Companies

Updated on Aug 20, 2025 | Published on Oct 2, 2023 By Jason Ellis, PhD

Smiling Worker Holding a Tablet in a Sterile Facility

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 …

Fragile Immune Cells Require Gentle Handling

Updated on Apr 7, 2025 | Published on Sep 15, 2023

Immune Cells Under a Microscope

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 …

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