BPI White Papers Archives - Page 11 of 35 - BioProcess InternationalBioProcess International

Minimize Risks and Enhance Speed and Flexibility with Sterile Fill/Finish Support for Clinical Supplies

Industry changes, such as shorter timelines and increased product complexity, can often introduce additional risks to the sterile fill/finish process, resulting in production delays, additional costs, and safety concerns. Additionally, the advent of personalized medicines brings challenges to manufacturing and supply chain structure, emphasizing the need for speed and flexibility. Join Eurofins BioPharma Product Testing and Vanrx (now part of Cytiva), for an in-depth discussion covering ways to eliminate human error and other associated risks when producing small batches of…

Managing Frozen Transport Logistics in the Biopharmaceutical Cold Chain

by BPI Contributor

The enormous task of establishing a reliable infrastructure to supply COVID-19 vaccines across the globe has thrust cold chain shipping and its associated challenges into the spotlight. Valuable biologics, such as vaccines and recombinant therapeutic proteins, are often kept in a frozen state during storage and shipping. This requires robust solutions to ensure temperatures do not fluctuate and product integrity is preserved. As biopharmaceutical manufacturing grows increasingly global, the production and transport networks required to keep operations running smoothly become…

How to Find Expression and Purification Conditions That Result in High Levels of Thermally Stable Membrane Proteins

by BPI Contributor

It’s very common to experience low expression levels when producing membrane proteins — plus they’re finicky and unstable when they’re outside of their native environment. Just know, you’re not alone. In this webinar, we’ll introduce you to the latest technology and techniques that will help you: More easily find the best expression and purification conditions that yield properly folded membrane proteins, saving you time and resources in producing membrane proteins that are stable and functional for downstream use Characterize the…

Optimizing the Accuracy of Biopharma Flow-Measurement Applications With the BioProTT™ FlowMeasurement System

by BPI Contributor

The BioProTTTM FlowMeasurement System for the non-invasive measurement of volumetric flows within flexible tubing systems is suitable for both industrial and laboratory applications. It always consists of an evaluation device and a sensor. To ensure the highest possible accuracy, each sensor is adjusted and calibrated according to certain parameters based on the customer’s application. In addition, there are also external factors that impact the accuracy. This document will highlight and explain these factors so that system integrators and operators are…

Biosimilar Structural Comparison of Commercially Sourced Reference Standards by MMS Rapidly Detects Subtle but Critical Differences to Correctly Predict Activity for Use in an ELISA Product

by BPI Contributor

It was determined that many of the Bovine Serum Albumin (BSA) reference candidates did not exhibit acceptable activity after inclusion into the final product though all purchased samples shared the same name and identification. The inconsistency in activity causes delays, increases cost of manufacture, and adds an element of variability. Current in-house biophysical techniques fail to correctly identify the inactive candidates prior to product inclusion due to inconclusive results or a lack of sensitivity. Thus a more accurate, reliable analytical…

Evaluate Cell Therapy Product Purity with Aura CL

by BPI Contributor

The CAR-T development workflow is a multi-step process that includes transfection of T cells with a viral vector to express a chimeric antigen and activation/expansion of the CAR-T using a molecule like a Dynabead conjugated to CD3/CD28. Each of these steps is a potential source of contamination that needs to be removed to ensure the purity of the final cell therapy product. Aura CL™ applies multiple detection methods to facilitate the accurate detection and identification of contaminants in a CAR-T…

Media Management: A Critical Consideration Before Intensification

by BPI Contributor

Process intensification (PI) enables faster drug development and increased productivity, flexibility, and quality. But PI can also introduce the challenge of increased media volumes and how to manage them in upstream processes. This whitepaper provides the tools and information needed to consider PI options while evaluating the implications of media management. Follow the media journey from prep to use, exploring potential logistical pitfalls in managing increased media volumes associated with process intensification. Finally, see how the right equipment and platforms…

Octet® Bio-Layer Interferometry Systems: Advancing Development of Coronavirus Vaccine and Therapeutics

by BPI Contributor

Development of vaccines and therapeutics to target outbreaks of infectious diseases such as SARS-CoV-2 requires speed and agility. An essential part of this rapid response are technologies designed to streamline and accelerate workflows while delivering high quality data for informed decision-making. This compendium of applications demonstrates the use of the Octet® label-free platform utilizing bio-layer interferometry (BLI) technology to advance development of coronavirus vaccine and therapeutics. The fluidic-free approach offers important advantages over microfluidics-based technologies such as surface plasmon resonance…

Strategies for Successful Formulation Development of Lipid-Based RNA Delivery and Vaccines

by BPI Contributor

Nucleic acid therapy using RNA and DNA as the active pharmaceutical ingredient (API) has the potential to cause a paradigm shift in the way diseases are addressed. This innovative therapy targets the source of the disease at the genetic level and can be used to modulate the expression of one or more proteins simultaneously – a unique advantage over conventional biologics or small molecules. Given this mode of action, RNA and DNA therapeutics are a powerful means to treat, and…

Shaping the Future of Formulation Development with Melt-based 3D Printing Technologies

by BPI Contributor

Three-dimensional (3D) printing is a powerful technology that has wide-ranging applications, including many in the pharmaceutical industry. Among the approaches that are being explored in the production of pharmaceutical dosage forms powder-based systems which utilize either drop-on-powder or selective laser sintering and liquid-based systems which use drop-on-drop deposition or stereolithography are frequently applied. With liquid-based technology, either UV, laser energy or high temperature is used to induce polymerization and build the 3D structure. The process of 3D printing offers the…