News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Bispecific antibodies (BisAbs), which can bind to two distinct antigens, are prone to high levels of aggregate (10-30%), challenging traditional platform downstream processes and impacting product yields. Mixed-mode chromatography (MMC) presents a...
Process characterization and validation is an important step in the product development journey and late-phase development, and it is required before transferring an existing manufacturing process.
Optimize your protein A step with a novel resin for elution at higher pH levels.
As the Pharma 4.0 initiative sets a new industry paradigm, more biomanufacturing companies are asking how they can design and build facilities that apply risk-based thinking to manufacturing innovation.
Actylis manufactures buffers, process solutions, cleaning solutions, Water for Injection (WFI) for further processing, and custom liquid blends in compliance with Good Manufacturing Practices in our new state-of-the-art GMP liquid processing facility in...
By combining 75+ years of manufacturing and sourcing expertise, Actylis provides a wide portfolio of GMP ingredients to the pharma & biopharma market, including excipients, APIs, PIs, amino acids, nucleotides, process solutions and buffers.
To solve for the significant bottlenecks often presented by conventional cell line development processes, this article discusses how Wheeler Bio is leveraging transposon-based gene delivery to compress timelines, increase clone stability, and offer...
The future of the biopharmaceutical industry hinges on its adoption of 21st-century digital tools and automation.
As the world grapples with the effects of ongoing health crises, the market is expanding quickly as developers shift their focus to proactive therapeutics.
Our newest strong anion exchange resin provides both high binding capacity and high recovery, even at high flow rates. A rigid bead complete with optimized pores and surface extenders, this robust resin was designed for your large...
Would you like to enhance your downstream process, increase production capacity and reduce costs? This case study application note demonstrates how implementing inline volume reduction before a final diafiltration step can improve your process...
Accelerate Your Process Development. Your technology selection guide for the clarification of mAb processes.
The Cadence inline diafiltration (ILDF) device is designed for continuous processing, in-process buffer exchange or contaminant removal in various processes in a wide range of applications. This includes buffer exchange for final drug substance,...
In September 2017, BioPharma-Reporter.com conducted its second annual ‘state of the industry’ survey on its user base of biopharmaceutical industry professionals. The key objective of the survey was to gauge views about the current state of the global...
DNA concentration, mastermix preparation, temperature management: Doing PCR like a pro can be more complex than it seems.The Eppendorf infographic helps you to stay on top of your PCR.Our tips and...
The Cadence™ BioSMB platform from Pall Life Sciences is the first disposable flow path, continuous multicolumn chromatography solution that is fully scalable from the process development (PD)...
mAbs are produced for a number of therapeutic applications. However, mAbs are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability...
Virus filtration is a vital part of the viral clearance strategy in bioprocesses. In filtration, size exclusion mechanisms are orthogonal to other inactivation or removal techniques and target...
Learn the advantages of transferring from single column to continuous chromatography processes with connected unit operations. This poster titled “Demonstration of a mAb Chromatography Platform...
In May 2016, BioPharma-Reporter conducted its inaugural ‘state of the industry’ survey. The key objective of the poll was to gauge views about the current state of the biopharmaceutical...
Reverse pipetting, problem liquids, getting the angle right: Pipetting like a pro can be more complex than it seems. The Eppendorf infographic helps you to stay on top of your most difficult...
Pall’s single-pass tangential flow filtration (SPTFF) technology provides a simple solution for continuous concentration and optimization of DSP steps. The Cadence™ Inline Concentrator (ILC)...
The Applikon BioSep system is a unique, cell retention device for high-density perfusion processes. BioSep is the ultimate tool for cell culture perfusion from 100 ml scale bioreactor up to...
In collaboration with ProBioGen AG, Mustang Q chromatography membrane was evaluated as a polishing step following protein A affinity and cation exchange chromatography to remove residual host cell...
Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies...
Assessment of biosimilar molecules requires an orthogonal analytical approach. Any one particular analytical technique is not able to fully define the physical and biological characteristics of...