BPI White Papers

CAP®Ad – A Versatile Platform for RCA-free, Industrial Scale Adenoviral Vector Production

Adenoviral vectors are frequently used as gene delivery tools for various medical applications. In most cases, replication-incompetent adenoviruses are employed, which, once they have infected a target cell, cannot spread further in the patient‘s body. In such applications, regulatory guidelines require that the formation of replication-competent adenoviruses (RCA) in the production process must be minimized. Since the risk of RCA occurrence depends on the adenoviral vector and the cell line used for generating the virus stock and for manufacturing the…

PendoTECH Sensors and Industry 4.0: Integrating a PendoTECH Single Use Sensor System with a Digital Highway

Biopharmaceutical manufacturing is currently evolving with the progression of Industry 4.0. Industry 4.0 refers to the ongoing Fourth Industrial Revolution, which is currently transforming modern manufacturing and production practices through the use of “smart” technology. This is especially appealing to the biopharmaceutical industry, where production can be a long, meticulous, complex processes, and optimizing manufacturing procedures is critical for success. As a leading supplier of single use technology for the biopharmaceutical industry, PendoTECH has recently explored how its products can…

The Importance of Raw Materials in Viral Vector Manufacturing

Focus on transfection reagent. The rapid advance of so many gene therapy candidates is creating several key challenges. There is a strong need for higher viral vector yields and scalable manufacturing to reduce costs of gene therapy for affordable patient treatment, all of that while meeting cGMP compliance to ensure patient safety which, push comes to shoves, always comes first. A critical step for viral vector manufacturing is sourcing of raw materials to maximize production yield while meeting quality requirement.…

Successful Drug Development with Synthetic Lipids: Critical Aspects and Strategies

Currently gaining enhanced momentum due to their vital role in the development of vaccines against COVID-19, lipid-based formulations and lipid nanoparticles have shown a lot of promise in drug development and delivery particularly because of their ability to enhance active pharmaceutical ingredient (API) stability by protecting the API from immune response, proteases and other factors; boost the solubility and bioavailability of drugs with poor water solubility; passively target inflamed or tumor tissues due to their leaky vasculature, known as the…

A Guide to Accelerating Cell Line Development for Commercial Production

Effective, high-quality cell line development (CLD) is essential for success in the commercialization of protein biologics, but there is no one right way to tackle it. Some companies have extensive in-house capabilities and look for reliable equipment suppliers to help streamline early-stage development and enable a smooth transition to manufacturing. On the other end of the spectrum, certain companies need a fully outsourced solution to provide cell lines, products, and experienced professionals to oversee the entire CLD project. And others…

Reagents Matter – Osmolality Testing in Gene Therapy Manufacturing

Osmolality testing provides a versatile measure of solute concentration that is an important consideration in the manufacture of gene therapies. This white paper discusses how monitoring osmolality of media during upstream viral vector production and reagents during downstream purification processes can influence quality of the final product. The dependence of multiple biological processes on osmolality, coupled with the usefulness of its measurement in vector quality control, means that osmolality testing is a powerful method to support a high yield of…

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…