Thermo Fisher Scientific has recently announced the release of a new application-specific LC System.
It said its new Vanquish Analytical Purification LC system combines the separation power of analytical LC with precise fractionation to generate high-purity products or for the isolation of contaminants.
Users will get precision in purification across their whole analytical workflow, with the introduction of the new integrated Vanquish Fraction Collector, according to the developer.
Biopharmaceutical laboratories working at the forefront of new drug development require detailed characterization of impurities. “The addition of the new Vanquish Fraction Collector enables researchers to isolate and purify compounds right after their analytical separation,” said Kent Davidson, vice president and general manager, high performance chromatography solutions, Thermo Fisher.
Mission Bio has launched an assay that it claims will prepare makers of cell therapies for new safety and regulatory standards.
The developer said its new VCN Assay, its latest CGT assay for the Tapestri single-cell multi-omics platform, is both simplifying a complex process and vastly improving the sensitivity of batch measurement.
"For the first time, developers of cell therapies like CAR-T cells will be able to apply multi-omic analysis to assess the cell-to-cell variability of vector copies within a batch, rather than averages gleaned from bulk analysis that can hide potentially oncogenic cells."
The explosive growth in cell therapy development over the past few years has put regulators on the spot, and FDA has raised the bar for drugmakers to prove their cell therapies are safe, commented Mission Bio.
That means demonstrating modifications and edits to cells are happening as intended. “The VCN Assay improves on today’s complex, multi-tool approach that can miss potentially oncogenic outliers within a cell batch. It does this by simultaneously measuring vector copy number and transduction down to single cells.”
Photo credit: GettyImages/artisteer
Sartorius says it is bringing a scalable, ready-to-use disposable Protein A membrane to market, triggering a paradigm shift in the monoclonal antibody capture step by overcoming nearly all the limitations of packed bed chromatography.
Biopharmaceutical companies who use packed bed chromatography for mAb capture often suffer from low productivity, higher costs, and laborious operations.
Sartobind Rapid A. a one-batch, one membrane approach, can save up to 30% on overall process cost in clinical scale manufacturing and produces data faster with rapid cycling and high binding capacity to perform lifetime studies within one day, said the developer.
The ready-to-use membrane product makes it possible to bypass column-packing, cleaning validation and storage, reducing non-productive activities around column use by 80%, said the company.
Pall Corporation has extended its bioprocessing technology portfolio with the launch of three new Allegro Connect Systems.
In conjunction with Pall’s Allegro single-use portfolio, it said these systems are designed to deliver enhanced process and risk control, through the full automation of unit operations that combine to support the production of a wide range of therapeutic drugs and vaccines.
The Allegro Connect Systems portfolio now includes systems to support Depth Filtration, Virus Filtration and Bulk Fill of drug substance, and join the Buffer Management System to simplify the creation of manufacturing workflows.
Pall said the Allegro Connect Systems integrate previously manual operations, such as filter integrity testing and single-use system leak testing, reducing the need for operator intervention. With intuitive hardware, software and consumable designs, the process is simplified from installation through to batch reporting, with streamlined access to critical process data for faster, more secure batch release, added the developer.
Ed Hoare, vice president and general manager for biotech at Pall Corporation, said: “In an increasingly dynamic bioprocessing environment, the challenge of supporting a growing variety of modalities and manufacturing workflows can easily lead to proliferation of system designs and a complex array of solutions. These can slow the specification cycle and often lead to rigid system designs that struggle to keep pace with changing process demands. Our new Allegro Connect System design combines our decades of bioprocessing knowledge with direct insights from process owners and developers to simplify those choices and deliver greater process flexibility through optimized configurability.”
Suncombe recently announced the global release of the updated GMP Water Heating Skids.
The skid mounted systems provide a robust and repeatable method of heating, storing and distributing hot water under cGMP auspices, it said.
The skids comprise all the necessary water storage tanks, heaters, pumps, valves, pipework and related components and instrumentation to deliver the required hot water. Type, quantity and physical sizes of components are determined during the design phase of each project to suit the required application, according to Suncombe.
System construction and components are suitable for cGMP sanitary use in pharmaceutical, biotech and other hygienic applications, it explained.
Systems include a user-configurable recipe-based control system to suit a wide range of applications and are pre-assembled and fully tested with operating utility supplies in our works to minimise risk and optimise installation and validation time on-site.
They comply with all applicable regulatory standards and are accompanied by a comprehensive suite of documentation covering all aspects of installation, operation and maintenance.
They help companies meet sustainability goals, said the developer, as they are available with steam or electrical heating components, and there are also options for heat recovery and reclaim, along with the ability to choose heat pump technology.
