Drug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services.
Performing dissolution tests on high potency drugs with low concentrations of active pharmaceutical ingredients is difficult, if not impossible, with a standard apparatus 1 or 2 dissolution bath. Common analytical instruments are not sensitive enough to detect such low concentrations. Distek's Small Volume Conversion Kit offers the perfect solution to these common dilemmas.
The Distek Eclipse 5300 Automated Dissolution Sampler offers rapid, accurate sampling using precision syringe pumps. The elimination of valves and rotary pumps along with the optimized sample pathway increases reliability while reducing common sources of sample carryover.
Many of the main causes of OOS dissolution tests and qualification failures are related to media deaeration and dispensing. The unique compact design and optional mobile cart lets one easily move the unit from bath to bath, while the available remote dispensing nozzle allows directly filling vessels in place. The ezfill+ is compatible with most dissolution baths on the market.
The Distek sensIR 3200 combines two exclusive technologies – bathless heating and Near IR sensing to offer the most innovative disintegration tester. Bathless heating not only reduces warm-up times but eliminates the inconveniences associated with conventional water bath-based instruments. The sensIR 3200 is available in two, four or six positions in the smallest footprint of any comparably equipped model.
The Cipher dissolution control software is a Windows-based application designed and developed by Distek which can be installed locally or networked providing full access to any Distek dissolution instrument on the network. Cipher offers the flexibility to set the level of security appropriate for your laboratory and will meet 21 CFR part 11 compliance.
The Rituximab ELISA kit is intended for the quantitative determination of Rituximab in serum, plasma and cell culture samples. Validated against International NIBSC standards by WHO.
Enzyme Immunoassay for the quantitative determination of Dasatinib in serum, plasma and cell culture supernatant.
The Nivolumab ELISA kit is an assay intended for the quantitative determination of Nivolumab in serum, plasma and cell culture samples.
Enzyme Immunoassay for the quantitative determination of Anti-Atezolizumab antibodies in serum and plasma.
The Infliximab ELISA kit is intended for the quantitative determination of Infliximab in serum, plasma and cell culture samples. Validated against NIBSC international standards from WHO.
Enzyme Immunoassay for the quantitative determination of Anti-Natalizumab antibodies in serum and plasma.
Enzyme Immunoassay for the quantitative determination of Sacituzumab Govitecan in human serum and plasma.
Immunoassay for the measurement of Bovine Serum Albumin in cell culture samples.
The Desmpressin ELISA kit is intended for the quantitative determination of Desmopressin in serum and plasma samples.
Enzyme Immunoassay for the quantitative determination of Anti-Adalimumab antibodies in human serum and plasma.
Aura® GT helps you realize the promise of gene therapies, without using a lot of your viral vector sample throughout the development process. Avoid conditions and formulations that facilitate viral vector aggregates, monitor DNA leakage, and ensure product quality with just 5 µL of sample per data point.
Aura® PTx gets you to your best formulation faster! Backgrounded Imaging (BMI) technology to give you accurate count, size, and morphology information about particles in your sample. Couple that with Fluorescence Membrane Microscopy (FMM), which gives you definitive ID of protein aggregates and an easy way to monitor polysorbate degradation.
Rapidly develop pharmaceutical formulations and adopt continuous processing methods using the Pharma 16 Twin-Screw Extruder. It can switch between continuous hot melt extrusion (HME) or wet granulation (TSG) with ease. Optimize drug process development parameters with less time and effort than batch processes and easily scale-up to larger Thermo Scientific extruders using minimal amounts of expensive APIs and excipients.
VisualAI™, an add-on module for VisualSpreadsheet 6, is a pre-trained, AI-driven image analysis module that recognizes images of biopharmaceutical aggregates captured on any FlowCam 8100 or FlowCam LO instrument. VisualAI is a powerful tool for quantifying protein aggregate and silicone oil droplet content in protein-based drug products.
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