17 Drug Discovery & Pharamceuticals New Range of Anti-Eculizumab Antibodies Introduced
Bio-Rad Laboratories, Inc has announced the launch of a range of recombinant monoclonal anti-idiotypic antibodies that inhibit the binding of eculizumab (Soliris) to its target, complement C5 protein. These anti-eculizumab antibodies detect free drug and are designed for use in drug level monitoring assays and biosimilar development.
The new range of recombinant monoclonal anti-idiotypic antibodies is comprised of four inhibitory antibodies that are highly specific for the humanised IgG2/4 kappa monoclonal antibody drug, eculizumab, a biotherapeutic that is used to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. The anti-eculizumab inhibitory antibodies can be used to quantify the level of eculizumab in patient samples and they may also be used in bioanalytical assays for biosimilar development. An antibody pair is suitable for the development of a pharmacokinetic (PK) bridging ELISA, and antibodies of high, medium, and low affinity can be used as a positive control or calibrator in an anti-drug antibody assay.
The recombinant monoclonal anti-idiotypic antibodies are generated using the Human Combinatorial Antibody Library (HuCAL®) and CysDisplay®, a proprietary method of phage display with guided selection methods to obtain highly targeted reagents. The recombinant production method also ensures a consistent and secure supply.
“Bio-Rad’s portfolio of highly specific anti-biotherapeutic antibodies continues to expand, providing critical reagents for use in preclinical and clinical development of biosimilars, and for therapeutic drug monitoring of patients,” said Amanda Turner, Bio-Rad Product Manager, Life Science Group. “Our unique anti-eculizumab antibodies are well characterised and have been validated for use in PK and immunogenicity assays. Adding new specificities to our portfolio will help researchers overcome challenges associated with assay design and sensitivity,” she added.
The anti-eculizumab antibodies are approved for in vitro research and for commercial applications of in vitro testing services that support preclinical and clinical drug and biosimilar development and patient monitoring.
48428pr@reply-direct.com Fluorescent Biosensors as Tools for Drug Therapeutics
Researchers in the School of Pharmacy at the University of Nottingham have been using Dolomite Microfluidic’s chips to enhance their work on drug encapsulation and therapeutic delivery. Dr Veeren Chauhan, Research Fellow in the Advanced Materials and Healthcare Technologies (AMHT) group, working with Dr Jonathan Aylott and Dr Amjad Selo, explained: “We have been using Dolomite chips since the end of 2017 and, since then, have continuously manufactured an array of uniformly-sized PLGA particles. We can fine-tune the system set-up, depending on the downstream requirements, to provide a consistent particle shape and size, as well as control drug release parameters. These attributes are key to ensuring the correct dose of drug is maintained, achieving maximum therapeutic benefit without unwanted side-effects.”
Amjad added: “We are optimising conditions to produce fluorescent PLGA to act as a biosensor, storing and releasing biological medicines dependant on environmental changes. These novel particles can detect and monitor specific analytes in the body and, due to their fluorescent properties, can be used to assess biochemical interactions and processes within cells.”
“Using Dolomite’s microfluidic chips has significantly enhanced the innovative work we are able to perform. The beauty of using such small chips means we can produce vast quantities of particles, while occupying very little lab space, and can ensure a continuous flow of homogeneous, reproducible particle batches,” Veeren concluded.
48792pr@reply-direct.com ADVERTORIAL Temperature Controlled Specifi c Rotation Measurement in Accordance with Latest Pharmacopoeia
Recent changes within pharmacopoeia states that optical rotation measurements for all monographs must be taken at 20 ±0.5°C. Traditionally laboratories look to external waterbaths to perform such a function but with limited laboratory space and budget in mind, Bellingham + Stanley’s latest ADP450 polarimeter with XPC Technology, Xylem’s patented on-board Peltier temperature control system for measuring optically active samples at stable temperatures, offers a viable alternative to cumbersome peripheral devices.
Capable of measuring up to 3.0 OD at 589nm over a maximum tube length of 200mm, the ADP450 offers three decimal place precision to an accuracy of ±0.01 °Angular, making it ideal for general purpose use across many different industries; especially within pharmaceutical research, production and quality control laboratories.
A ‘single-shot’ reading mode provides a discrete measurement for pharmaceutical controlled conditions; whilst the PHR-Method allows a statistical analysis of up to 10 samples from a production run; with all results recorded along with statistical batch analysis. The Methods system also provides rapid confi guration for sample specifi c scale reading (optical rotation, specifi c rotation, % sucrose, % glucose, etc.) and experiment temperature set-point (20 or 25°C) as well as performing sample limit checking against stored assays.
Latest ADP450 models have newly enhanced onboard software to help laboratories comply with FDA regulation 21 CFR Part 11; without the additional costs or data security risks associated with a PC & software. Recording of results, instrument access and confi guration is also possible as too is a Review & Approve electronic signature process that may even be achieved remotely. Encrypted Print to Secure PDF, csv and XML outputs makes data integration to LIMS simple, secure and auditable.
For laboratories looking for that extra accuracy or the ability of measuring at other wavelengths, the fl agship ADP600 Series polarimeters offer not only the above but 3-decimal place accuracy and a variety of pharmacopoeia cited wavelengths across the UV and visual spectrum too.
More information online:
ilmt.co/PL/XvpW 48753pr@reply-direct.com
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