Sponsored Content Archives - Page 92 of 143 - BioProcess InternationalBioProcess International

Continuous Processing Optimization With Smarter Tools

Single-use technology (SUT) has long been viewed as a viable solution to today’s biopharmaceutical manufacturing challenges. It offers the flexibility to change a production configuration to meet demand while also offering many other cost benefits, such as savings related to the elimination of clean-in-place (CIP) and sterilization-in-place (SIP) processes. However, traditional and fed-batch models fail when trying to adapt to single-use flexibility due to the required rewriting of code and revalidation. The best way to use the flexibility of single-use…

Impact of Single-Use Tangential Flow Filtration in Downstream Bioprocessing

by BPI Contributor

This webcast features: Michael LaBreck, Sales Director, Repligen TagenX Products Single-use solutions are fast becoming platform in bioprocessing as a response to pressure to optimize process economics and process efficiencies. Implementing single-use alternatives in tangential flow filtration (TFF), a critical step in downstream bioprocessing for concentration and diafiltration (buffer exchange), is a major part of this transformation. Repligen TangenX™ SIUS™ Single-use Cassettes are the first purpose-built cassettes designed for tangential flow filtration. This webinar will demonstrate how deploying these innovative…

Accelerating Biosimilar Development Programs using Contract Testing and Manufacturing Organizations

by BPI Contributor

A rapid increase in the number of companies working on the development and registration of biosimilars and the need to get these products to market with speed has lead biosimilar developers to turn to contract research organizations (CROs) when they lack either the internal capability or capacity for conducting certain work. Throughout the biosimilar development pathway, a product sponsor can choose to conduct the work itself or use service contractors. Contractors can be niche providers of a single aspect of…

Contract Test Services from Associates of Cape Cod, Inc.: Specializing in Testing for Endotoxin and Glucan Contamination

by BPI Contributor

Associates of Cape Cod,® Inc. Contract Test Service (CTS) laboratory specializes in testing for endotoxin and glucan contamination and has notable experience in endotoxin testing. CTS performs all methods of the BET assay: gel-clot, chromogenic, and turbidimetric. CTS is GMP compliant and ISO registered. We’re licensed by the DEA as a laboratory capable of handling all controlled drug substances except those included in Schedule I. Endotoxin testing can be performed in accordance with FDA, USP, EP and/or JP, depending on…

Platform Purification of Six Biosimilar Molecules Using Amsphere A3 – Protein A Resin

by BPI Contributor

Currently more than 70 biosimilar mAbs (monoclonal antibodies) are under development and multiple originator mAbs are going off-patent in the next 3-4 years. Protein A resin remains the most important workhorse for the purification of monoclonal antibodies. Protein A resin has a high impact on both development and manufacturing cost, in particular during early stage clinical phases. This application note summarizes the key performance parameters for our high capacity protein A resin, Amsphere A3, for 6 biosimilar molecules of which…

Special Report: Effect of Insulin on Cell Growth and Virus Production

by Aziza Manceur

Recombinant insulin is a key component in serum-free growth media for mammalian cells. It is used for the manufacturing of monoclonal antibodies, virus vaccines, gene therapy products and many other biological drug products approved by regulatory bodies worldwide, including FDA and EMA. Canada’s National Research Council (NRC) helps companies develop and commercialize new health technologies. Recently it partnered with Novo Nordisk Pharmatech to determine the effect of Insulin on cell growth and virus production. The results are detailed in this…

Synergizing Transient and Stable Protein Expression for Accelerated Biotherapeutic Development

by BPI Contributor

This webcast features: Krista Steger, PhD, Scientist, MaxCyte Transitioning early stage discovery efforts with later stage development activities is critical for moving biological therapies into the clinic in an efficient and timely manner. MaxCyte’s scalable Flow Electroporation™ Technology allows gram-scale transient expression of antibodies and other proteins in cell types that are relevant to biomanufacturing. At the same time, the high levels of efficiency and viability provided by MaxCyte transfection, can shorten timelines and reduce labor involved in generating clonal cell…

Multi-Gram Scale Antibody Production Using CHO Cell Transient Gene Expression (TGE) via Flow Electroporation™ Technology

by BPI Contributor

Despite advances in transfection methods and culture optimization, many CHO-based TGE systems produce insufficient antibody titers (low mg/L level) for full use within biotherapeutic development pipelines. The high productivity of MaxCyte-driven transient gene expression allows for its use in early phase candidate identification as well as for generating the gram-level antibody quantities needed for later stage pharmacology, stability and manufacturing studies. In this white paper, data are presented demonstrating the reproducibility, scalability and antibody production capabilities of MaxCyte Flow Electroporation™…

Advanced Materials for Single-Use Biomanufacturing Systems

by BPI Contributor

This webcast features: Michael W. Johnson, Business Development Engineering Manager, Life Sciences, Entegris Utilizing advanced fluoropolymer materials in single-use systems has distinct advantages in regards to extractables, chemical compatibility and cold temperature performance. This webcast examines data obtained from pilot scale testing of a new fluoropolymer single-use bag system for the freezing, storage and shipping of formulated bulk biopharmaceutical product. You will learn: What material has the widest temperature profile from +200 to -200°C Which film material (LDPE, Polyolefin, EVAM,…

Implementing Global Best Practices and Technology Specifications for Single-Use Systems

by BPI Contributor

As global markets become more and more important, so does global manufacturing. But when your company has several manufacturing sites across the world it can be difficult to streamline efforts, manage costs and share valuable information. Our recent white paper “Implementing global best practices and technology specifications for single-use systems” tackles the issues of multinational drug manufacturing and offers several best practices that can help you cut your time to market, lower probability of process troubleshooting during start-up and decrease…