BPI White Papers

Bispecific Antibodies Unleashed

Advances in disease biology have led to the burgeoning development of bispecific antibodies (BsAbs), which are synthetic proteins capable of targeting two discrete epitopes from different antigens. Their bispecific functionality offers promising therapeutic potential such that their applicability to a variety of therapies is being explored. Originally developed for the treatment of cancer, BsAbs may now benefit imaging and diagnostics, as well as disease prevention and treatment. Several bispecific antibodies have already obtained regulatory approval, while hundreds more are in…

Enabling Next Generation Holderless Flat Sheet TFF

Traditional TFF cassette designs have been in use for more than 30 years. Reduce setup time, eliminate torquing and decommission time that traditional TFF cassettes require. TangenX SC is a new TFF device design that does not require a holder and eliminates torquing. It can help you: Reduce your TFF process set up time by 80% with a plug-and-play true flat sheet device Eliminate decommission time Easily scale from traditional PD cassettes because of the consistent path length Learn more…

MaxCyte® Flow Electroporation® for Gram-Scale Transient Antibody Production in CHO-S Cells

High efficiency, scalable electroporation of CHO cells with MaxCyte enables rapid gram-scale protein production, extending the potential use of transient gene expression throughout antibody development. As the demand for therapeutic antibodies intensifies, methods for the rapid manufacture of high-quality protein are crucial. MaxCyte Flow Electroporation enables scalable and highly efficient transfection of clinically relevant cell lines producing grams of protein within two weeks. In this Application Note, we discuss some of the factors that are critical for high-yield transient gene…

Breakthrough in mAbs Processing with State-of-the-Art Chromatographic Clarification

Are you involved in the upstream or downstream processing of mAbs and challenged with inconsistent throughputs between runs and/or at different scales? Are you in search of a solution that can effectively handle high cell densities or high contaminant loads? Are you struggling to find a scalable clarification solution, especially at large scale? Have you considered whether the multiple stages required to achieve acceptable cell culture fluid clarity may be leading to lower product yield and longer process time? If the…

Fcγ Receptor and Antigen Kinetic Screening for Rapid Biosimilar Downstream Processing Assessment Using Octet® BLI

Demonstrating biosimilarity throughout upstream and downstream production processes is crucial. However, screening all potential candidates using standard analytical methods can be challenging. To overcome this, an alternative high-throughput analytical approach is needed. In this application note, we showcase the ability to rapidly test a Humira® biosimilar (adalimumab) development sample against three key ligands, meeting regulatory requirements. Our approach involves combining a single analyte kinetic screen of a monoclonal IgG1 antibody against the Fcγ receptors CD16a V176 and CD64, along with…

The Powers of Odin: Comprehensive Cellular Characterization

Prokaryotic and eukaryotic cells change and adapt to their environments in ways that genomic characterization methods do not fully capture or predict. Even strains of the same species of microbe can show key differences in pathogenicity or sensitivity. Phenotypic analysis provides a complementary method for effectively characterizing the functional properties of cells. Biolog Phenotype MicroArray panels with redox reporter dyes have made this type of analysis possible for many years, as researchers grow their organisms under thousands of different pre-selected…

Scalability from Mobius® 3 L Single-Use Bioreactor to 50 L – 2000 L Mobius® iFlex Bioreactors to Support Intensified Upstream Process Development

Properly scaling from small-scale bioreactors to larger-scale bioreactors for intensified processes is highly dependent on maintaining mixing, oxygenation, nutrient, and process control. To be able to meet these criteria, bioreactor systems need to have a well-characterized design space while considering risks and ways to control hydrodynamic shear. Extensive understanding of the bioreactor design space and the environmental conditions experienced by the cells within the systems’ operating range enables more informed process development and predictable performance across scales. The Mobius® 3…

Your Ultimate Guide to Raw Materials Testing Support

No bio/pharmaceutical product can be manufactured without first establishing the identity, purity and quality of its starting materials to ensure the product is suitable for its intended use. When this critical step in the bio/pharmaceutical manufacturing process is performed successfully, costly production problems and delays can be avoided. Eurofins BioPharma Product Testings’ North America sites offer a comprehensive GMP raw materials testing package supporting compendial & non-compendial analysis, containers testing, characterization testing, metals testing, mycoplasma testing and more. Our extensive…

Simplifying the Antibody Drug Conjugate Supply Chain: One company’s mission to drive efficiencies and mitigate CMC development and manufacturing challenges

There are currently over 250 antibody drug conjugates (ADCs) in global clinical trials. This historically high number says more, perhaps, about drug developers’ belief in these novel, complex modalities than it does about how difficult or expensive it can be to bring them into the clinic. Challenges faced in the process of discovering, engineering, and developing ADCs start with identifying a highly specific antibody with the necessary binding affinity to the disease target, and then coupling the antibody with the…

Automated Aseptic Aliquoting: Unprecedented Flexibility For Good Filling

Automated filling of drug substance is the way to go. Human error is the main cause of operational errors and process deviations in pharmaceutical manufacturing. Automated aliquoting into single-use bags help optimize fluid management significantly. It prevents overfilling, reduces the risk of contamination, shortens operating time and prevents incompatibilities with rigid filling systems. Among all available systems for automated filling of biopharmaceuticals and advanced therapies, RoSS.FILL, a platform for filling and filtration of primary packages, including single-use bags and bottles,…