Needle-free diluent technology
The Needle-Free diluent kit is a concept created by bioluz and Technoflex in response to the FDA and the UK?s National Health Service (NHS) publishing recommendations to prevent healthcare staff from needle-stick injuries during the reconstitution of intravenous (IV) drugs.
The Needle-Free diluent kit is a concept created by bioluz and Technoflex in response to the FDA and the UK’s National Health Service (NHS) publishing recommendations to prevent healthcare staff from needle-stick injuries during the reconstitution of intravenous (IV) drugs.
The kit consists of the active substance in a vial (lyophilized powder), a diluents bag and a sterile, blister‑packaged needle‑free device. Reconstituting the IV drug into a flexible bag is completed within a few steps.
Compared with traditional methods, this technology is easy to use, safe (needle-free), avoids mixing errors and saves time because all components are provided in the same package. Furthermore, as the vial is always attached to the bag, it is clear which active substance has been added in the bag and how much. Although this technology is more expensive than traditional methods, its benefits outweigh the cost, as evidenced by its popularity in the US; we expect a similar uptake in Europe. Eventually, we hope to improve this technology by supplying the kit pre-assembled.
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
The Role of Forced Degradation in Method Development, Manufacturability, and CMC Strategy
April 28th 2025Forced degradation studies are critical in biologics development, particularly for monoclonal antibodies (mAbs). These studies simulate long-term environmental stressors to uncover degradation pathways and ensure the stability of critical quality attributes (CQAs), aiding in robust chemistry, manufacturing, and controls (CMC) strategies and regulatory compliance.
