Join us in Boston next week (booth #700) for the BioProcess International conference. This event represents our first combined marketing effort in the Life Sciences sector since our acquisition in 2020.Read More
Flow Imaging Microscopy is currently recommended by the USP as an orthogonal analytical method for biopharmaceuticals. It has yet to be integrated into every drug development and testing laboratory however. Integrating new technologies upstream in the formulation development process continues to be an essential path for improving the safety and efficiency of the drug development. Once new methods and technologies are proven and accepted upstream, it's possible to pave the way for new technologies to be implemented downstream and beyond.
Hundreds of biopharmaceutical and pharmaceutical companies worldwide are now using the FlowCam to improve the quality, safety and stability of their formulations. Since most teams purchasing an analytical instrument for their lab want to read studies conducted by other scientists, we have gathered a collection of the top influential studies using the FlowCam to demonstrate how they are integrating Flow Imaging Microscopy into their research.Read More
Pharmaceutical and biopharmaceutical laboratories require rigid characterization of the particulate matter in injectable therapeutics. FlowCam technology offers a benchtop imaging particle analysis tool with unique software features that can discriminate particles based on morphological properties. The data obtained from FlowCam analysis can be used to verify the quality and integrity of parenteral drugs.Read More
In a recent paper discussing particle counting and analytical techniques, the number and type of particles present in intravitreal injection formulations of three different drug agents used against vascular endothelial growth factor were investigated.Read More
Biopharma labs today are looking for ways to improve accuracy, safety and productivity. The use of robotics to enable the unattended, continuous running of samples is gaining popularity. The following post can help you determine if an automated liquid handling system can help your formulation development lab attain the goals of reproducibility, traceability and flexibility.Read More
This week the Bioprocessing Summit is happening in Boston and virtually.
The popular 9th Annual Rapid Methods to Assess Quality & Stability of Biologics conference track will bring together experts in analytical and formulation development to discuss rapid and practical ways to accelerate prediction and screening for protein instabilities in early- and late-stage development. The conference features case studies, unpublished work on new methods and tools employed in real-time and accelerated stability studies for proteins, cell and gene therapy products, high-throughput analytics, developability assessment, high-throughput analytics, multi-attribute methods, post-translational modifications, and stability in vaccines.Read More
Sub-visible particle characterization is a critical method for assessing drug substance and drug product quality and stability. In this study, we evaluated the capabilities of the new FlowCam Nano (which utilizes patented oil immersion flow microscopy), in conjunction with a peristaltic pumping study that focused on protein particle formation generated during filling pump operations.Read More
Cell-based medicinal products (CBMPs) offer promising opportunities for the treatment of diseases with previously limited or no therapeutic options. However, the complexity and intrinsically fragile nature of these CBMPs create significant challenges in formulation development, analytical characterization, manufacturing, and stability assessment.This recent study used a FlowCam, Flow Imaging Microscope (FIM) assisted by machine learning software, to measure cell viability and concentration, and to quantify debris particulates. These particulates were the result of forced degradation studies that mimic conditions from cell procurement to administration of product. In particular, the effects of freeze-thawing and shaking on CBMPs were studied. Read More
There continue to be ongoing concerns about post-manufacture particulate formation in biopharmaceutical drug products. The stresses, which induce particle formation in IV infusion bags, are suspected to be related to the type of diluent (i.e., saline or dextrose).Read More
Silicone oil has long been used in the pharmaceutical industry as a lubricant for syringes. It serves to reduce the force necessary to depress the plunger, and can make procedures more comfortable and safer for the doctor and patient as it allows the needle to slide more easily through the eye wall.Read More