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mPEG Alcohols and Activated mPEG Derivatives Development and Manufacturing

mPEG Alcohols and Activated mPEG Derivatives Development and Manufacturing

Capability & experience to develop and manufacture customized Methoxy Polyethylene Glycol (mPEG) and activated Methoxy Polyethylene Glycol (mPEGs) derivatives curated to meet varied end applications.

We have 15+ years of experience with Methoxy Polyethylene Glycol (mPEG) and activated mPEG development and manufacturing. We perform mPEG development at our R and 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.

Aurigene 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.

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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

US FDA audited facilities

Backward integration of mPEG alcohol

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