BPI White Papers

Three Steps to Start You on the Path to Obtaining the Best Recombinant CHO Cell Line

When developing efficient, high quality biomanufacturing processes, it is imperative that the expression system (‘host cell line’ and ‘vector’) and the process to isolate and identify the best clonal cell line (‘clonal cell line development process’) are of the highest quality. At FUJIFILM Diosynth Biotechnologies a team of scientists has invested more than 20 FTE years undertaking innovation work which has culminated in the development of a new host cell line and vector, along with an optimised clonal cell line…

Computer-Aided Assay Development for Charge Heterogeneity Analysis by iCE

Unlike chemically synthesized drugs, protein therapeutics are a dynamic heterogeneous mix of active compounds. Due to their complexity, analytical techniques like isoelectric focusing have become indispensable tools in evaluating biologic preparations. The resulting surge in charge isoform analysis has led to major advances in instrumentation, such as Imaged Capillary Electrophoresis (iCE™)2 . However, to obtain the full benefit from improved instrumentation requires the coinciding development of robust assays. The goal of this note is to promote the successful application of…

Use of ScreenExpert RoboColumns for High Throughput Study of Loading Conditions on HyperCel™ STAR AX and MEP HyperCel Sorbents for MAb Purification in Flow-Through Mode

The use of HyperCel STAR AX and MEP HyperCel sorbents for MAb polishing provides efficient contaminant removal. A study to screen loading conditions for MAb purification in flow-through mode on MEP HyperCel and HyperCel STAR AX sorbents was conducted using 200 μL ScreenExpert RoboColumns. The study demonstrates the suitability of ScreenExpert RoboColumns for scale down evaluation of chromatographic parameters, and the good consistency with data obtained on 1 mL PRC prepacked columns. ScreenExpert RoboColumns allow loading of high sample volume…

Implementation of Mustang® Q Membrane Chromatography as a Polishing Step (Residual DNA Removal) in Monoclonal IgG1 Production from CHO Cell Culture

In collaboration with ProBioGen AG, Berlin, Germany, Mustang Q membrane chromatography was evaluated as a polishing step following protein A affinity and cation exchange chromatography to remove residual host cell DNA during a Monoclonal antibody (MAb) purification process at 250 L cell culture production-scale. Data indicated efficient DNA clearance by the Mustang Q membrane chromatography step during the process (96%). Additionally, contribution of the Mustang Q membrane chromatography polishing step to HCP removal was shown. Based on a virus-spiking scale-down…

Flow Electroporation Capabilities and Case Studies: Rapid GPCR Screening and Functional Ion Channel Assays

MaxCyte’s proprietary flow electroporation technology has been successfully applied in ex vivo cell therapy (1) and drug discovery pipelines where reproducibility, efficiency and the need for increased cell numbers are critical. This technical paper discusses the merits of transient transfection using flow electroporation versus other recombinant expression approaches and its application in hit identification and lead optimization programs. Data are presented demonstrating the key features of the MaxCyte® STX™ Scalable Transfection System, including broad applicability, scalability, and the production of…

Delivering Fit-for-Purpose Biomanufacturing CHO Cell Lines

A prerequisite for the successful manufacture of a biopharmaceutical in mammalian cells is a cell line development strategy that selects a cell line with the most desirable properties from a heterogeneous transfectant population. Desirable attributes include the stable, high expression of product with the appropriate critical product quality attributes rapidly, reproducibly and with relative ease. Obtaining a host cell line that inherently exhibits such desirable biomanufacturing attributes can therefore have a significantly positive effect on the identification of recombinant cell…

Assessing Immunogenicity Using Ex Vivo T cell Assays

This article discusses Antitope’s developed highly sensitive ex vivo T cell assay technology that can detect T cell responses against T cell epitopes in therapeutic proteins. These assays can be used to select non-immunogenic lead proteins as well as support the optimisation of leads by engineering out T cell epitopes

CaPure-HA Resin for Aggregate Removal from Monoclonal Antibodies

Scientists in the field of process chromatography methods development are constantly on the lookout for better and more selective ways to remove aggregates and other process related impurities from monoclonal antibody monomer. The data presented in the following paper demonstrates the capabilities of CaPure-HA to remove degradation products, dimer, and higher order aggregates from the monomer of a protein A purified IgG1 monoclonal antibody.

Multitron Pro: The Professional Incubation Shaker for Any Application

The Multitron Pro and the Multitron Cell manage to combine flexibility, user-friendliness and operational reliability with  optimum space utilization. A number of innovative options for cooling, precise CO2 control, illumination and hygienic direct steam humidification guarantee the ideal conditions for cultures. With around 500 different designs we meet almost every customer requirement. We are also more than happy to provide special configurations. INFORS HT provides you with Swiss quality with a modern design and a high technological level and environmentally friendly energy…

Scalable Protein Production Using Flow Electroporation

Many transient gene expression (TGE) methods produce insufficient protein quantities for full use within biotherapeutic and vaccine development pipelines. MaxCyte’s proprietary flow electroporation provides a universal means of highly efficient TGE for the rapid production of large-scale quantities of proteins, antibodies, antibody-like molecules, virus-like particles (VLPs), and vaccines. In addition, the platform can be used for generation of stable pools and stable cell lines that can greatly streamline biotherapeutic and vaccine development. Flow electroporation (co)transfects a wide range of cells,…