We have 15+ years of experience with Methoxy Polyethylene Glycol (mPEG) and activated mPEG development and manufacturing. We perform mPEG development at our R&D center in Hyderabad. Our team has extensive experience in synthesis, analysis, purification, and troubleshooting of mPEG derivatives and have technical capabilities in synthetic route design to incorporate various activating groups and help customize products as per end applications.
APSL is a leading manufacturer and supplier of Methoxy Polyethylene Glycol (mPEGs) and activated Methoxy Polyethylene Glycol (mPEGs) which are used for the conjugation of proteins, antibody fragments, and peptides. With our GMP manufacturing capabilities and backward integration to highly pure Methoxy PEG-OH, we guarantee the quality and security of the supplies of our activated Methoxy PEGs (mPEGs) products.
As a leading CDMO, we understand customer requirements and customize our products to meet the client’s requirements. Currently, we serve multiple customers in various products such as diagnostic players, other mPEG suppliers, and big pharma using mPEG for advanced therapeutics. In addition, our backward integration of key raw materials makes it possible to ensure a sustainable quality of the final activated mPEG throughout the manufacturing process.
We have technical capabilities in synthetic route design to incorporate the activating group and help customize products as per end applications. Our centers at Hyderabad and Mirfield are equipped with advanced instruments to enable the scale-up of activated mPEG production up to 90 kg per batch.
Successful custom PEGylation requires several factors to be optimized such as the site of PEGylation, chain length, and mPEG linkers. Determining the optimum mPEG may require the testing of several activated mPEGs at different chain lengths. We offer a range of activated linear mPEGs to enable our customers to find the ideal mPEG for conjugation of the required quality, with high levels of activation, narrow polydispersity, and low diol content.
Key highlights of our services:
Backward integration of mPEG alcohol
mPEG-OH is the key raw material for the synthesis of activated PEGs. Our backward integration of key raw materials makes it possible to ensure a sustainable quality of the final activated mPEG throughout the manufacturing process. Our process to make high quality pharmaceutical grade mPEG-OH is patent protected. We manufacture mPEG alcohols in our Cuernavaca, Mexico site.
We support the production of mPEG-OH of molecular weight ranging from 2kDa, 5kDa, 10kDa, 20kDa, 30kDa, 40kDa, and 50kDa.
Various classes of mPEG derivatives we can handle
We are specialists in liner-activated mPEG. Our range of products includes various activating groups such as
- Methoxy PEG Maleimides (mPEG-Mal)
- Methoxy PEG pNP-Carbonates (p-Nitrophenyl Carbonate PEG)
- Methoxy PEG Propionaldehyde (mPEG-CHO)
- Methoxy PEG Amine (mPEG-NH2)
- Methoxy PEG NHS Ester
- Methoxy PEG Iodoacetamides
- Methoxy PEG Thiols (mPEG-SH)
- Methoxy PEG epoxide
- DBCO-mPEG
We support the production of mPEG derivatives of molecular weight ranging from 2kDa, 5kDa, 10kDa, 20kDa, 30kDa, 40kDa, and 50kDa.
Activated mPEG manufacturing at Mirfield and Hyderabad
We help aid our customers with supplies for their development and clinical purposes. We manufacture mPEG derivatives from our Mirfield, UK and Hyderabad, India sites. Key features of our sites are as below:
- Annual capacity ~430 Kg (variable activating groups)
- Clean room manufacturing suite for medium-scale cGMP chemistry (1 - 300 L)
- Temperature range 0 to 150°C
- Hastelloy hydrogenation or pressure reaction to 20 bar
- Stainless steel filter drier of 100 L capacity, 3 bars
- DCS computer control
- Heat transfer oil for accurate temperature control
Analytical capabilities
The analysis of large polymeric materials such as PEGs can be challenging. Our analytical lab is equipped with advanced equipment and analytical instruments to determine the quality of our highly pure mPEGs.
Also, we have a highly experienced analytical team who can characterize the compounds for any required impurity specifications and develop as well as validate such methods.
We perform all critical analytical tests in-house such as:
- Identification of compounds by NMR
- Analyzing impurities by HPLC
- Testing molecular weight and polydispersity by GPC
- Residual solvent content by GC
- Heavy metal analysis by ICP-OES
- The expected results would be +/- 10% variation
Why Aurigene Pharmaceutical Services?
Technical know-how to deliver the most challenging specifications
Experience and legacy of working with big pharma clients
Analytical capabilities
USFDA audited facilities
Backward integration of mPEG alcohol
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
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