Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so that they can focus on what’s most important in their lives. By working together, we envision protecting or enhancing…

Rentschler Biopharma is an international contract development and manufacturing organization (CDMO) dedicated to biopharmaceutical development and biomanufacturing for over 40 years. We are leading experts with an exceptional track record of over 100 different therapeutic protein formats. As a world-class solution provider, we ensure optimum time to proof-of-concept for clinical stages I and 2, as well as time to market for products in clinical stage 3. By accelerating timelines under consideration of economically attractive process options, we generate a competitive…

Single-use technologies (SUTs) can introduce leachables (chemicals that migrate from polymeric components into the drug product) to a manufacturing process. Herein, we describe an effective process to manage the risk from leachables to ensure patient safety and prevent delayed product launch. Early implementation of leachables risk evaluation strategies can reduce the resources and time required for risk mitigation later in a project’s life cycle. Fill out the form below to read this technology review now.

Viral contamination is an inherent risk during the manufacture of therapeutic products such as antibodies, vaccines, viral vectors, and plasma derivatives. Whether introduced endogenously from raw materials or exogenously through manufacturing operations, unmitigated viral contaminations can lead to serious health implications and facility shutdowns. Thus, international regulatory agencies require sponsoring companies to validate the “viral clearance efficacy” of their downstream purification process steps before clinical trials or commercial approval. This technology review describes the MockV MVM kit for viral clearance…

Messenger RNA (mRNA) therapeutics have the potential to revolutionize several areas of medicine, including the prophylaxis of infectious disease. That potential is driven not only by therapeutic advantages of this modality, but also the relative ease in which a product can be produced and scaled — thus reducing cost and importantly, time to market. mRNA therapeutics have an enhanced safety profile driven in part from their mode of action not requiring integration into the host-cell genome. mRNA vaccines are a…

Bio4C™ ProcessPad data visualization, analytics, and process monitoring platform enables bioprocess life-cycle management, reporting, investigations, and continued process verification (CPV). The system intelligently combines process data from disparate sources into a single, validated data source. The Bio4C ProcessPad platform also facilitates 21 CFR Part 11 compliance and ensures access within a validated environment to verified process data that is current and contextual throughout a product life cycle. Fill out the form below to read the complete technology review now.

Countless factors influence a bioprocess, and measuring and evaluating them can be a major challenge. One of the most important performance parameters is the volumetric mass-transfer coefficient (kLa). ZETA has developed a reliable method for determining the kLa value and thus has revolutionized bioreactor design in plant engineering. With ZETA’s mass-transfer coefficient value determination system, measurements to determine kLa value can be taken at any point in a bioreactor, and based on such measurements, production conditions can be mapped perfectly.…