BPI White Papers

Assessing Your AAV Capsid Content for Product Quality? Get the Confidence You Need with an Automated CE Platform

Looking for a hassle-free and rapid analytical method to detect full, partially filled, and empty Adeno-associated virus (AAV) capsids for your gene therapy development? Viral capsid content can impact gene therapy product efficacy and is therefore considered a Critical Quality Attribute (CQA) that must be properly evaluated during the development and manufacturing of AAVs. Traditional analytical tools such as transmission electron microscopy (TEM), analytical ultracentrifugation (AUC), and ion-exchange chromatography (IEX) can be used to characterize capsid content but are complex…

Cell Line Development: Accelerating Process Optimization by Combining Ambr® 15 Cell Culture with Octet® Titer Measurements

Cell line development (CLD) involves the screening of thousands of clones to find those that are stable, produce high yields of the bioproduct and exhibit desired critical quality attributes (CQAs). Typically screening and process optimization activities will be carried out at the small scale in bioreactor cultures to ensure that results translate up to larger bioreactor scales. Performance data is primarily based on cell growth, cell viability, metabolite analysis and product titer, and assessed over the entire culture process duration.…

Enhancement of Tablet Coating Using an Innovative Functional Excipient

During formulation of solid dosage forms, film coating is used to improve the appearance and stability of tablets, make them easier to swallow, mask the taste, modify or sustain release, protect the drug from the harsh gastric environment, protect from moisture and/or oxidation and, as a result, to improve the stability and overall therapeutic effect of the final drug product. Depending on the individual needs, a polymer with appropriate properties is chosen during formulation development to serve as film-coating matrix.…

Cytiva Strategy for Host Cell Protein Control

A critical aspect of therapeutic development and manufacture is host cell protein (HCP) detection, quantitation, and removal from drug substances, to ensure efficacy and prevent immunogenicity. It is important to mitigate risk by challenging your assay for each new molecule and selecting the most suitable kit. Cytiva offers a range of solutions to support scientists and developers in creating an effective strategy for HCP control. Read more about our strategy for HCP control.

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…