BPI White Papers

Guidelines for Developing a High Cell Density Cryopreservation Process

Biopharmaceutical manufacturers are leveraging several approaches to intensify processes with a goal of improving efficiency and productivity and reducing costs — all while ensuring the highest quality standards. The upstream workflow offers several opportunities to apply next generation technologies and methods to achieve these important goals. In this white paper we discuss integration of high cell density cryopreservation (HCDC) in the seed train and explore key considerations for developing a cryopreservation process including choice of cryoprotectant and freezing techniques.

GatorTM AAVX Probes for Rapid and Label-free Quantitation of AAV Serotypes

Adeno associated virus (AAV) capsids are a leading modality for in vivo gene delivery. Complete and precise characterization of capsid particles, including capsid and vector genome concentration is necessary to safely and efficaciously dose patients. In virus development and production, it is important to determine the virus concentration at different stages of the process, optimize the clone used and obtain best production yields. Easy, rapid and cost effective quantitation methods are critical to achieve above goals. The Gator AAVX probes…

Ensuring Quality Oversight in Plasmid DNA Manufacturing

The landscape of today’s biopharmaceutical industry is changing rapidly with the introduction of novel drug products, such as personalized medicines. However, while this sector of the market is expected to have a major impact on patient care in the coming years, it also presents significant challenges during development and manufacturing. One such area is a gap in GMP quality plasmid DNA (pDNA) supply, an essential building block for viral vector and even mRNA based vaccines and therapies ― the latter…

Cell Therapy Production: A Comprehensive Look at Key Elements of Success

Cell therapies offer tremendous potential to treat diseases for which there is often no treatment available. The global cell therapy market is strong and continues to expand. Market research predicts an annual growth rate of 5.4% reaching $8.83 billion by 2027. Cell and gene therapies continue to progress through the clinical pipeline with new cell therapy product approvals, expansion of approved indications for current products, as well as increasing awareness, acceptance, and use of these advanced biological products globally. This…

Optimizing Control of Pump-Related Biopharma-Production Processes

In biopharma production, pumps are used in a variety of critical processing steps, most notably for liquid transfer that requires the creation and adherence to a required flow rate and pressure level. While this can be done manually through the reading of a pressure gauge and adjusting the motor speed if the pressure should venture outside of the acceptable range, this way is time-consuming and lacks the precision that an automated system can provide. Automated pumps became viable after they…

Fluorescence Reveals Hidden Details in Flowers That Attract Pollinators

Analytical bioprocess scientists and lab managers must capture images at the highest resolution and across a large spectrum, without compromising image quality. The Amersham ImageQuant™ 800 (IQ800) imager allows automatic high-resolution imaging across the entire visible spectrum, from UV to infrared. The IQ800 system is equipped with six different types of light-emitting diodes (LEDs) and corresponding filters, making imaging easy for a wide variety of applications beyond chemiluminescence. The best gel and blot images without the guesswork using SNOW imaging…

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

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

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

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…