Specialties

PEGylation - PEGtech

CPS is one of the leading manufacturers and suppliers of Activated mPEGs for the conjugation of proteins, antibody fragments and peptides; to improve the stability and the pharmaco-kinetic properties of biologic drugs. With outstanding GMP capabilities and back integration to high purity mPEG-OH, we can guarantee the quality and security of the supply of our Activated mPEG products. Our product range, branded under the PEGtech name, has the following characteristics:

• Varied activating groups including: Maleimide, pNP-carbonate, Propionaldehyde, Amine, NHS ester, iodoacetamide, thiol etc.
• Full range of molecular weights: from 5 to 40 kDa
• Narrow polydispersity
• Excellent levels of activation
• Low diol content
• Non-GMP and GMP manufacture from Lab to Commercial scale
• Custom activation and branched PEGs

Our customers range from Biotechs to large Pharma organizations, in the development of biologic drugs. Routinely CPS-Chirotech can provide small scale samples prepared at our R&D facilities in Cambridge, UK, with clinical and commercial scale manufacture at our GMP production site in Mirfield, UK.

Back integration to the key raw material ensures that we are able to control the quality of the final activated mPEG, throughout the manufacturing process. Our process to make this high quality pharmaceutical grade mPEG-OH is patent protected: US 7199193 B2. The level of control that we offer brings an assurance of supply, and reliability that is valued by our customers. We have clients at all stages of the clinical trials process, including several in late stage phase III trials. Our Activated mPEGs are also in a launched drug, Dr Reddy’s Peg-grafeel™. Approved use in a launched drug has been achieved by few other Activated mPEG suppliers.

Unique Analytical Approach

Analysis of large polymeric materials such as PEGs can be challenging, but it is crucial that a high level of accuracy is achieved, to ensure high quality. For example, the diol impurity must be minimised to prevent the formation of di-functionally activated molecules, capable of cross reactivity. We have developed proprietary and unique mPEG analytical methods which separate diol and the di-functionalised impurities derived from diol, on the basis of functionality alone. This technique, “LC under critical conditions” is effective because all weights are coalesced, see below. Thus the interference associated with different molecular weights is eliminated. Our analytical methods, which we have patented (US 7824919 B2) ensure that we measure all the di-functionalised content in our activated mPEGs.

Successful PEGylation requires several factors to be optimised, such as the site of PEGylation, chain length and mPEG linker. Determining the optimum mPEG may require the testing of several activated mPEGs, at different chain lengths. CPS-Chirotech offers a range of activated linear mPEGs to enable our customers to find the ideal mPEG for conjugation. Our activated mPEGs are high quality, with high levels of activation, narrow polydispersity and low diol content.

We offer a varied range of activated mPEGs, some of which are shown above. Our standard linear mPEG chains weights are 5K, 10K, 20K, 30K, 40K with other weights available on a custom basis. We also make custom activated mPEGs in collaboration with our customers. We can offer this range and flexibility because of our back integration into our own mPEG-OH, our synthetic skill and our established manufacturing expertise. Click here to enquire.

As one of the leaders in the provision of Activated mPEGs to the pharmaceutical industry, CPS-Chirotech is a preferred supplier of these complex and enabling materials. With a comprehensive product range and tailored services, we are the ideal partner for the development and commercial success of your biologic pharmaceuticals. 

For further information on our services and capabilities or any query regarding the PEGtech product range please use the enquiry button below.