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highly potent
We’ve just added another dedicated potent suite to our cleanrooms...
cytotoxics
"SCM Pharma has demonstrated strong technical knowledge during the development stage of our project and have since shown their expertise in production and packing this investigational medicinal product. Their introduction of in-house sterility testing along with the team’s flexible approach to help meet our needs made them the ideal choice to support our scaled-up Phase II clinical trial supply needs." Giacomo Chiti Head of Analysis & Bioanalysis, Molteni Therapeutics
formulation clinical trials Commercial

Back in the day, SCM Pharma was all about the small stuff. Pilot scale, short-runs and clinical batches. We loved this work. We still do in fact. Especially when it involves a little potent product. So, in a way, size didn’t matter to us.

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. As any successful service with a growing demand, eventually, you start to struggle with space or just slow down. So it got us thinking. Maybe size does matter after all.

With this in mind, we decided to act. Firstly, we needed to continue looking after the sexy small scale stuff. Secondly, it was essential we could support exciting expansion through clinical trials. And finally, meet the needs of clients requiring critical commercial supply.

And so. We added another dedicated potent suite to our cleanrooms at SCM HQ in 2011. 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.

So in a way, we were right all along. Size really doesn’t matter. 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? C14? They’re all right up our bright orange-lit street.

Potents (inc. cytotoxics and cytostatics)
 
Within our facility, we are licensed to handle highly potent products, for example cytotoxics and cytostatics. We have a dedicated cleanroom with its own air handling system, 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 capsules 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.
 
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.
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