cGMP manufacturing & contract drug manufacturing | SCM Pharma

Our Services

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Potents (inc. cytotoxics, cytostatics & flammables)

Within our facility, we are licensed to handle highly potent products, for example cytotoxics, cytostatics and flammable substances. We have dedicated cleanrooms with their own air handling systems, designed specifically for the manufacture of such products. This-state-of-the-art technology provides a quality solution for clients for the containment and development of new formulations.

This capability includes being able to produce small volume runs and the handling of cytotoxic powders and liquids, which we can fill into ampoul or vials. Part of the process design includes the use of disposable isolation systems to eliminate the risk of product cross contamination and reduce the need for extensive cleaning validation. Our potent suite can provide you with a fully contained process for dispensing, manufacturing and packaging.

Recent developments at SCM Pharma include the innovative design of disposable isolator technology, which can provide you with a low cost solution to complex potents’ processing with full environmental controls – humidity, temperature, pressure and environment. The use of disposable technology for all the equipment dedicated to your process can minimise your investment.

Such products can be produced as aseptic, terminally sterilised (autoclave or irradiated) or clean. With collaborative investment, we also have the capacility to introduce freeze drying to our process capability, which will allow us to deliver even greater flexibility for final product presentation.

Some background...

As time has gone by, our clients’ projects have grown and changed. From a handful of ampoules to a hundred. And from a hundred vials to a thousand. Being a flexible CDMO, we have adapted to our clients’ potent product manufacturing needs.

In 2011, we added another dedicated potent suite to our cleanrooms at SCM HQ. Our expanded potent capacity allows us to handle multiple potent productions at any one time. This means quicker turnaround of potent products, regardless of your project’s stage.

And it doesn’t stop there. We also developed a production technique to handle continuous throughput via our isolators to boost our aseptic processing capacity. And, in the spirit of scaling-up and speeding-up to help meet our clients’ varying needs, we also invested in some shiny new filling equipment too.

Small pilot batches, growing clinical trial quantities or the regular supply of licensed products. When it comes to cGMP filling of potent products, we really do have a one size fits all approach.

Delivering novel, difficult and dangerous products such as sterile filling of a cytotoxic compound is what we do best. Liquid? Powder? Fammable? C14? They’re all right up our bright orange-lit street.

Feel free to click on the list of services at the top of this page to find out more about what we can do and how we can help you.