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GMP Kilo-Scale Synthesis & Manufacturing
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GMP Kilo-Scale Synthesis and Manufacturing The best way to keep costs down during the early phases of your drug development project is by working with a company that specializes in kilo-scale synthesis and manufacturing. Cedarburg Hauser Pharmaceuticals has the experience and expertise helping our clients quickly and economically develop processes to synthesize and produce a few non-GMP grams of their compound in our labs for toxicity trials as well as scaling the process up to manufacture up to several kilograms of GMP material in our GMP kilo-scale labs and suites for their clinical trials. We have experience successfully manufacturing not only our clients’ APIs, but our own commercial APIs as well. The APIs have included potent compounds, controlled substances and a variety of compounds that have required complex chemistry. We know what it takes. We understand what is important. We know how to get the job done efficiently and economically, factors that are critical during early phase projects. Do you need an experienced kilo-scale synthesis and manufacturing partner for your current or upcoming project? This e-mail address is being protected from spambots. You need JavaScript enabled to view it now to discuss your project! GMP Kilo-Scale Quality Systems, Procedures and ControlsCedarburg Hauser Pharmaceuticals has designed our quality systems, procedures and controls around ICH Q7 to meet cGMP requirements for APIs. We have SOPs surrounding critical elements including…
Find out more about our GMP quality systems, procedures and controls GMP Kilo-Scale Laboratories & EquipmentCedarburg Hauser Pharmaceuticals has two facilities in Wisconsin and Colorado with 7 GMP kilo-scale labs that have the capability to produce just a few grams of your material during the early stages of development up to several kilograms of GMP material for clinical trials. Our labs have…
Our equipment can be easily adapted to your project’s needs… We have the flexibility to match our equipment to your processes – We don’t just match your processes to our equipment. Because we have a wide variety of types and sizes of glassware and equipment that we can quickly and economically move in and out of our GMP kilo-scale labs, we can easily adapt to the changing needs and stages of your project. Our equipment includes…
Your project will also have easy access to our on-site analytical labs and equipment which includes…
See additional information about our analytical method development, optimization and validation services We Can Scale with the Growing Requirements of Your Project
We can scale-up to your specific needs without the challenges often associated with transferring the technology from supplier to supplier. Next Steps…Do you need an experienced kilo-scale synthesis and manufacturing partner for your current or upcoming project? This e-mail address is being protected from spambots. You need JavaScript enabled to view it now to discuss your project! We also provide a comprehensive suite of API development services for you project, including…
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Dedicated HVAC systems for each suite with single-pass air controls to prevent cross contamination
21 R&D fume hoods
NMR, 400 MHz, JEOL Eclipse
We have the experience, expertise, equipment and facilities to scale your early stage development needs into greater quantities as you move through the phases of development and into commercial production. Your drug development and manufacturing project can be seamlessly transferred from our smaller bench-top hoods to our walk-in hoods and finally into our complete GMP production suites that house reactors up to 500 gallons.