Drug Discovery & Pharmaceuticals


Instant Onsite Verifi cation of Raw Materials for the Pharmaceutical Industry


Metrohm is pleased to present the latest compliant handheld Raman solution for the pharmaceutical industry. Mira P offers enhanced resolution, new immersion sampling and validation accessories, and ergonomic features that improve user experience. Mira P is fast, easy, and accurate helping users optimise the inspection of incoming goods, formulation verification, and process monitoring.


Mira P and its dedicated software, MiraCal P was developed in collaboration with some of the world’s leading pharmaceutical companies. New features streamline verification routines and include an automated training set builder and improved model analysis tools. Soft- and firmware improvements, like a colour-coded audit trail with advanced management features, ensure that users can easily reference samples even in massive databases. FDA compliance is met with customisable reports, automated report generation and export, and in-software viewing and printing. Following USP and EP guidelines has never been easier with the new CVA (Calibrate/Verify Accessory). This new attachment ensures accurate performance of Mira P and the quality of results with a thorough calibration and verification routine.


Mira P is IP67 rated and MILSPEC 810G tested, as expected from our rugged handheld analysers. In combination with our new guided workflow, this makes Mira P a perfect solution for the demanding pharmaceutical environment. From verification of morning deliveries to reviewing a day’s audit trail, Mira P helps increasing the efficiency of the typical workflow in the pharmaceutical manufacturing industry.


More information online: ilmt.co/PL/L4me 48334pr@reply-direct.com 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 configuration for sample specific scale reading (optical rotation, specific 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 configuration 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 flagship 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


New Kits to Support Drug Development and Candidate Optimisation Launched


Hypha Discovery Limited, a leading microbial biotechnology company specialising in biocatalytic solutions for pharmaceutical and agricultural R&D companies, has launched its new line of PolyCYPs® kits. These provide scientists with a scalable, easy-to-use, oxidative catalytic technology to help meet regulatory safety testing requirements and for optimisation of drug leads prior to selection of the development candidate.


The PolyCYPs® platform is the vision of CSO Jonathan Steele who, together with fellow scientists at Hypha Discovery and Professor John Ward at University College London – supported by funding from Innovate UK – has leveraged Hypha’s proven microbial biotransformation technology to create the PolyCYPs® range. The platform enables the synthesis of cytochrome P450 (CYP) derived human and other mammalian metabolites, as well as novel hydroxylated derivatives. The diverse enzymes in the kit have been cloned from a selection of Hypha’s most effective biotransforming strains and have been proven to catalyse a variety of oxidation reactions.


PolyCYPs® kits are designed for two key applications. The kits synthesise CYP-derived metabolites of pharmaceutical drugs and agrochemical compounds to enable their identification and biological testing. In addition, the kits provide medicinal chemists with a tool to make arrays of polar derivatives in isolatable yields for identification and bioassay. These new polar derivatives can have advantages such as improved drug distribution, metabolism and excretion properties, as well as increased solubility and potency, and could ultimately increase the number of viable new chemical entities in development pipelines. Scalability is a key feature of PolyCYPs®with resupply of specific enzymes in the form of freeze-dried powders. Alternatively, outsourced screening and/or large scale production and purification is available at Hypha. The kits are provided in an easy-to-use format containing everything needed to conduct reactions – the user simply needs to add water.


Liam Evans, CEO of Hypha Discovery, said, “PolyCYPs® is an exciting evolution of Hypha’s leading biotransformation expertise. Supplying our clients with the means to quickly produce metabolites that are otherwise difficult to identify and synthesise satisfies an unmet technical need. This cutting-edge product is the result of four years of collaboration with Professor John Ward of University College London to whom we are very grateful, as we are to Innovate UK for their significant financial support. We predict strong growth in sales of this product line based on the positive feedback from our customers.”


More information online: https://ilmt.co/PL/2GjD 48179pr@reply-direct.com


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