Whitepapers


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All Whitepapers

Developing more effective chromatography resins for mAbs downstream processing is important ⏤ but it's not the only way to improve impurity clearance. In this study of the use of additives to enhance resin performance, two mAbs chromatography resins were examined. Both were used for a capture step, and additives were screened to reduce the nonspecific binding of impurities. The goal of the study was to optimize chromatography steps and thus increase the capacity and removal of impurities.

Newer, more complex targeted therapies are entering clinical development at rapid speeds, requiring facilities to increase manufacturing capacity levels in order to keep up with demands and under the strictest levels of containment.

Developing and manufacturing biologics requires compliant technologies and methods that provide excellent accuracy, consistency, and quality control (QC) with continuous automation potential to ensure the best possible product is delivered in the right time frame. PCR methods that enable quantification of target nucleic acid sequences—namely quantitative real-time PCR (qPCR) and digital PCR (dPCR)—have become core technologies for delivering high-quality results in a range of applications throughout biologics development and biomanufacturing. qPCR and dPCR methods are the gold standards for sensitive, specific detection and quantification of nucleic acid targets, which are useful for QC testing a wide variety of biologic characteristics.

Emergent CDMO offers development services, drug substance, and drug product manufacturing for biological products, from preclinical through commercialization. Download our overview brochure to learn more about our end-to-end service offerings.

Emergent's Winnipeg site is home to the Cytiva® SA25 Aseptic Filling Workcell, a gloveless, robotic filling isolator. Download our facts sheet to learn about the benefits of utilizing isolator technology.

Liposome Extruders

Liposome extruders are mainly used for the liposome formulation and achieving uniform size distributions. It is an ideal instrument to generate nanoscale liposome formulations, and to prepare exosomes and artificial cell membranes. By utilizing the tracked-etched filter membranes, the liposome extruders are capable

With successful applications in various nanotechnology settings, the NanoGenizer,a lab-scale microfluidic high pressure homogenizer, utilizes interaction high-pressure microfluidic jet technology, has gained increasing recognition due to its notable shear rate, excellent repeatability, and guaranteed scalability.

High pressure homogenizers, such as NanoGenizer, prepare nanomaterial by producing high flow velocity through a small orifice, using a specially designed internal fixed geometry under high pressure from 10,000psi to 40,000 psi. During the homogenization process, changes in physical, chemical, structural properties occur, and as a result, homogeneous suspension takes place at nanoscale. The pressure of a conventional homogenizer is within 15,000 psi, while a high pressure homogenizer can achieve 30,000 psi, and an ultra-high pressure homogenizer can reach up to 60,000 psi.

The objective of this white paper is to discuss the suitability of this versatile excipient in parenteral drug products and provide an updated summary of regulated parenteral drug delivery products in which DMSO is incorporated. It will also summarize emerging technologies in which DMSO is instrumental, primarily in the formulation / delivery of peptide drugs and biopolymers.