Upstream

Transforming Adenovirus Quantitation | Rapid, Automated, At-Line Approach Using Octet®️ BLI

Viral vector vaccines offer the advantage of a rapid response to emerging pathogens or even personalized cancer treatments. Adenoviruses (AV) represent one of the most versatile and well characterized viral vectors that have been used for clinical applications up to today. However, analytical methods for the development and manufacturing of adenoviral biopharmaceuticals are still challenging and require continuous improvement to facilitate fast and reliable vector quantification and functional assessment. In this application note, we report the development of a rapid,…

RevIT™ AAV Enhancer: Rev-up AAV genome production in upstream manufacturing

The overall goal of gene therapies is to target common genetic diseases, which will require both localized and systemic application of AAV. In order to make this a reality, all components of the manufacturing process need to be evaluated and optimized to reduce cost-of-goods and increase the number of patient doses obtained per run. RevIT™ AAV Enhancer substantially increases AAV genome titers across multiple serotypes and transfection platforms, including the TransIT-VirusGEN® Transfection Reagent and polymeric transfection reagents. Simple optimization will…

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…

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…

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…

Automated 32×32 Epitope Binning in a Single Assay

The selection of lead candidates in the development of therapeutic monoclonal antibodies (mAbs) is a critical decision. Designing a mAb that exhibits all the desired biological and pharmaceutical properties is challenging, and therefore, this process is primarily empirical. The classification of monoclonal antibodies (mAbs) based on their binding behavior can be a valuable tool for selecting promising candidates for further development. Such classification often involves grouping mAbs with similar epitope binding regions, which are known to share similar biological functions.…

Addressing the Gassing Rate in Bioreactor Upscaling – is vvm a Reliable Parameter?

Common approaches for the scale-up of bioreactors use the gas flow coefficient (vvm) as a criterion for volumetric flow rates. Besides being the most common decisive parameter when it comes to the scaling of the gassing rate, a defined vvm is frequently used in the context of process validation, and therefore considered essential for qualification. ZETA called the reliability of this parameter into question and evaluated the scaling competence of vvm in a study performed in the context of commissioning…

Eliminate Noisy Oxygen Measurements in Bioreactors for Good and Control Your Process with Ease!

Achieving process consistency is a critical goal in cell culture and fermentation operations. However, one common challenge in these processes is the accumulation of air bubbles on oxygen sensors. This can cause severe signal noise, which in turn can mask the true oxygen level, complicating process control and leading to variability. To avoid this issue, robust aeration control is crucial. You can improve growth, productivity, and product quality by ensuring adequate oxygen supply to cells. However, air bubbles on oxygen…