Microbial Integrity of FlowLinX® sampling systems

FlowLinX sampling needle assemblies are used to take non-intrusive sterile samples in biopharmaceutical processes, such as cell culture, fermentation, chromatography, and sterile bulk and transfer.

Sustainable Materials: Polyketone An Emerging Nylon Alternative

The pharmaceutical industry is constantly evolving, innovating, and creating high-quality drug products to meet the needs of the patient. Sourcing sustainable materials that meet stringent quality and design standards can be difficult. It is unusual to discover single-use components that check all the boxes: ISO 9001:2015 level quality, creative design, affordability, and sustainable material.

Comparative Performance Analysis of Cell Culture Flasks

The study conducted provides a comprehensive examination of the comparative performance of various styles of cell culture flasks commonly used for cell cultivation. The study evaluated key parameters such as cell density and proliferation of CHO, HEK, and bacterial cell lines in FlowLinX© cell culture flasks versus Corning© cell culture flasks. Additionally, the FlowLinX© cell culture flasks were tested for compliance with USP <788>, Particulate Matter in Injections.

Powder-Liquid Mixing Characterization Using Duoning Mixers

Mixing studies were performed on the 100L DuoMixer® and 20L MiniDuoMix® to quantitatively evaluate the mixing performance of each mixer.

Best Practices for Sterility Assurance in Single-Use Product Manufacturing

With the adoption of single-use products used in biopharmaceutical production, manufacturers have become increasingly reliant on suppliers for sterile assemblies and components. Sterility can be defined as the absence of microorganisms in or on various surfaces and within the packaging boundary of the product.

Solutions to Managing Supply Chain Disruption

The bioprocessing market has experienced tremendous demand in the last few years because of an aging world population and the COVID-19 pandemic. To address the needs of this growing demand
for biopharmaceuticals, significant investments have been made in the production of biologics through capacity expansion projects to scale existing production facilities and build new facilities.