SUNBRIGHT® and PUREBRIGHT® Series

NOF has a long reputation for producing high-quality Activated PEGs — the SUNBRIGHT® Series — and high-quality single-molecule PEGs — the PUREBRIGHT® Series — that possess the most suitable properties for the preparation of physiologically active drugs and biologics. Our SUNBRIGHT® Series and PUREBRIGHT® Series are characterized as extremely high-purity PEGs with a variety of functional groups. The products of this series are internationally recognized as optimal PEGylation drugs.

As illustrated in this figure, the application of Activated PEGs with various functional groups enables the introduction of PEG chains into drugs, enzymes, phospholipids, and other biologics. Covalent conjugation of hydrophobic macromolecules with Activated PEGs leads to the formation of macromolecular micelles (Polymer Micelles), which allow homogeneous dispersion of hydrophobic drugs in aqueous media. Furthermore, when PEGylated lipids are used as liposomes or lipid nanoparticles, the aqueous corona adds stability for homogeneous dispersal of the LNP drug preparations encapsulating drugs within them.

Currently, single-molecule PEGs — the PUREBRIGHT® Series — have been used in Antibody Drug Conjugates (ADC) as linkers to increase their hydrophilicity.

PEGylation plays an important role in the stabilization of drugs, increased circulation time, reduction of their antigenicity, and decrease in drug dosage, besides augmenting the targeting ability via binding biologics onto their surfaces.

Illustration of PEGylation applications
Polymeric micelle carrier

NOF's Product Advantages

High-Purity mPEG-OH: Starting Material for Activated PEGs

NOF manufactures high-purity methoxy-PEG-OH characterized by the absence of contaminating impurities and narrow molecular weight distributions. These highly pure methoxy-PEG-OH have so far been used for various commercial PEGylated drugs, such as PEG-Interferon and PEG-GCSF.

CH3O(CH2CH2O)n-H

NOF CORPORATION is the sole worldwide patent holder of these high-purity mPEG-OH and all their derivatives. *Patent No.: JP3050228, US6455639, KR0358276

Our methoxy-PEG-OH has the advantage of extremely low diol contents relative to those of competitors' products. As shown in the following graphs, our methoxy-PEG-5000 contains remarkably low levels of diol as impurities, besides providing a narrower distribution of molecular weights in comparison with our competitors' products. Employment of our methoxy-PEG-OH as the starting materials yields higher purity and higher activity of Activated PEGs. We manufacture our methoxy-PEGs with molecular weights from 2 kDa to 80 kDa.

Comparisons of GPC analysis of NOF (left) and conventional product (right)

About PEGylation

PEGylation technology is applied for biologics modifications including cytokines, therapeutic antibody fragments, interleukins, hormones, oligonucleotides, and other proteins and peptides.

PEGylation can be effective for:

  • Improving bioavailability
  • Prolonging blood circulation
  • Maximizing pharmacokinetics
  • Low-profile immunogenicity

NOF provides high-performance activated PEGs for PEGylated drugs from the early development stage to commercial use with over 20 years of experience in manufacturing high-quality methoxy polyethylene glycol. As the starting material of activated PEGs for pharmaceuticals, our activated PEGs have a narrow polydispersity and low diol content with a wide range of molecular weights, from 2 kDa to 80 kDa.

PEGylation Service:

Please feel free to contact us if you need PEGylated drugs using NOF Activated PEGs, SUNBRIGHT® Series.

Capabilities

cGMP Manufacturing Facilities

NOF Activated PEGs, SUNBRIGHT® Series are produced in facilities using state-of-the-art technology, operated under cGMP. The cGMP facilities are capable of producing small to large batch sizes, using proprietary know-how with scale-up procedures, depending on customers' needs.

These cGMP facilities have been audited by pharmaceutical companies throughout the world. NOF receives a consistently high reputation from our customers.

cGMP manufacturing facilities for high-quality activated PEGs

Research & Development

Our R&D facility was opened in December 2005. This allows us to continue our development of novel activated PEGs and new technologies for PEGylation.

Analytical Technologies

NOF has more than 30 years of history in manufacturing high-quality mPEGs and Activated PEGs. These experiences endow NOF with a thorough knowledge of PEGs and considerable achievement in the analysis of Activated PEGs. We also invented innovative analytical methods for assaying the purity of activated PEGs and for determining impurity levels.

High-Purity Activated PEGs

Application Chart for PEG Derivatives

We supply different series of PEG derivatives with various versatile functional groups.

Application chart for PEG derivatives
Abbreviation Reactive Group (X) Target Groups
NHS PEG
CS -CO-CH2CH2-COO-NHS -NH2, -OH, -SH
GS -CO-CH2CH2CH2-COO-NHS -NH2, -OH, -SH
GS2 -CH2CH2CH2-NHCO-CH2CH2CH2-COO-NHS -NH2, -OH, -SH
GS3 -CH2CH2-NHCO-CH2CH2CH2-COO-NHS -NH2, -OH, -SH
AS -CH2-COO-NHS -NH2, -OH, -SH
PS -CH2CH2-COO-NHS -NH2, -OH, -SH
HS -CH2CH2CH2CH2CH2CH2-COO-NHS -NH2, -OH, -SH
TS -COO-NHS -NH2, -OH, -SH
p-Nitrophenyl carbonate PEG
NP -COO-p-Nitrophenyl -NH2
Aldehyde PEG
AL, AL2 -CH2CH2-CHO -NH2
AL3 -CONH-CH2CH2-CHO -NH2
Amino PEG
PA -CH2CH2CH2-NH2 -COOH
EA -CH2CH2-NH2 -COOH
Thiol PEG
SH -CH2CH2-SH -SH, -Maleimide, -COOH
Maleimide PEG
MA -CH2CH2CH2-NHCO-CH2CH2-Maleimide -SH
MA2 -CH2CH2-NHCO-CH2CH2-Maleimide -SH
MA3 -CH2CH2CH2-NHCO-CH2CH2CH2CH2CH2CH2-Maleimide -SH
Iodoacetamide PEG
IA -CH2CH2CH2-NHCO-CH2I -SH

Custom Manufacturing

NOF has over 30 years of experience in supplying high-quality methoxy polyethylene glycol (mPEG) to pharmaceutical markets. The highest quality mPEG is our starting material of PEG derivatives, patented through our proprietary technology.

Based on our extensive range of technological know-how and capabilities, NOF offers custom manufacturing from early stage development to commercial scale.

Please feel free to contact us: info@nofamerica.com