Nektar – PEGylated opioid analgesic Reported positive Phase 3 clinical trial results

A short polyethylene glycol (PEG) and its pegylation to small molecules could make a huge difference. Nektar announced positive topline results from an oral Human Abuse Potential (HAP) study of NKTR-181, which is a first-in-class opioid analgesic.  NKTR-181 is a pegylated small molecule drug: a short PEG with six repeating ethylene glycol units conjugated to a compound which shares the same core structure with Oxycodone, a semisynthetic opioid. Based on Nektar website, the U.S. Food and Drug Administration (FDA) has granted the investigational medicine NKTR-181 Fast Track designation for the treatment of moderate to severe chronic pain.

“The NKTR-181 HAP study was designed to confirm and assess the relative oral abuse potential of NKTR-181 at its maximum analgesic or therapeutic dose (400 mg) and at a supratherapeutic dose (3 times to 12 times greater than its analgesic dose range of 100 mg to 400 mg) compared to common therapeutic doses of a Schedule II opioid, oxycodone. Its study’s primary efficacy endpoint demonstrated significantly improved chronic back pain relief with NKTR-181 compared to placebo (p=0.0019). Key secondary endpoints of the study also achieved high statistical significance. The study demonstrated that NKTR-181 had a favorable safety profile and was well tolerated.”

Posted in Blogs | Leave a comment

Marketed PEGylated Drugs Approved by FDA and in Europe

An excellent review article is published by scientists from Nektar Therapeutics, Bayer, Jansen, and Baxalta Innovations GmbH in the journal of Journal of Pharmaceutical Sciences.

Journal of Pharmaceutical Sciences 105 (2016) 460-475
Since 1990, 12 PEGylated biopharmaceuticals have been introduced into the market place as drugs for human use (Table 1).Eleven are PEGylated protein biopharmaceuticals and one is aPEGylated aptamer (Macugen) administered intravitreally. Adagen®, Krystexxa®,
Neulasta®, Oncaspar®, PEG-Intron®, Somavert®, and Plegridy® are PEGylated with PEG molecules having molecular weight of 5-20kDa. Cimzia®, Macugen®, Mircera®, Omontys®, and Pegasys®are PEGylated with PEG molecules of 30 or 40 kDa.
Marketed PEGylated Drugs
Posted in Blogs | 1 Comment

Custom Synthesis Options at Creative PEGWorks

green liquid in beaker being added to test tube

Do you need a special PEG reagent synthesized? You’re in luck! At Creative PEGWorks, we handle custom synthesis service for polyethylene glycol (PEG) and other polymers.

Working with a wide variety of functional groups and broad range of molecular weights, we frequently provide custom synthesis of:

  • Functional polymers: Design and synthesis of functional polymer derivatives like polyamino acid, PEG (polyethylene glycol), polyester, and glycosylated and PEGylated biodegradable polymers
  • Small molecules: Design and synthesis of novel organic molecules, API intermediates, stereoisomers, specialty amino acid derivatives, and oligomers
  • Monodispersed PEG: Design and synthesis of monodispersed PEG derivatives with functional groups used in PEGylation chemistry.

When you’re ready to get started with your custom synthesis, contact Creative PEGWorks for a quote.

Posted in Blogs | Leave a comment

Benefits of PEGylation in the Pharmaceutical Industry

covalent bond for polyethylene glycol

Wondering if you should use PEGylation for your products? There are a number of reasons to start using the PEG polymer, including the following benefits:

  • It’s a low-cost additive.
  • It reduces immunogenicity.
  • It provides prolonged residence time.
  • It has improved formulation properties.
  • It can improve product yields.

If you’re looking for a company to handle your PEGylation needs, contact Creative PEG Works, a biotechnology company located in North Carolina. We specialize in PEGylation as well as polymer modification, particle surface functionalization, and custom synthesis of reactive oligomers and polymers of many different molecular weights.

Posted in Blogs | Leave a comment

Novel PEG hydrogel as 3D synthetic extracellular matrix (ECM) for organoid culture

A recent article published in the leading scientific journal of Nature (Designer matrices for intestinal stem cell and organoid culture, Matthias P. Lutolf et al from the Ecole Polytechnique Fédéra…

Source: Novel PEG hydrogel as 3D synthetic extracellular matrix (ECM) for organoid culture

Posted in Blogs | Leave a comment

Novel PEG hydrogel as 3D synthetic extracellular matrix (ECM) for organoid culture

A recent article published in the leading scientific journal of Nature (Designer matrices for intestinal stem cell and organoid culture, Matthias P. Lutolf et al from the Ecole Polytechnique Fédérale de Lausanne (EPFL) in Switzerland, Nature, Published online 16 November 2016,  doi:10.1038/nature20168) reported the first intestinal and colorectal cancer organoid culture in fully defined extracellular matrix (ECM). Enzymatically crosslinked PEG hydrogel was used to modulate the 3D synthetic networks to support organoid formation. Organoids formed by self-organizing stem cells resemble their native counterparts in cellular content, multicellular architecture and functional features. This novel approach overcomes multiple limitations of current organoid cultures and greatly expands their applicability in basic and clinical research. The principles presented in this publication may be extended to identify designer matrices that are optimal for long-term culture of other types of stem cells and organoids. The authors stated that one of the aims is to mimic the basic physical properties of Matrigel without contributing any biochemical signals.

Creative PEGWorks congratulates this significant advancement in PEG hydrogel and their use in regenerative medicine. We are proud that our multi-arm PEG reagents (e.g. 8-Arm PEG-Acrylate) are used in this great work.

Posted in Blogs, cancer, Regenerative medicine | 1 Comment

The Importance of Quality Supplies

shutterstock_492128905

As a company that values your products and is concerned about the quality of what you produce, it’s important that you use only the best supplies. It can be difficult to find supplies and materials that are affordable but meet your quality standards.

At Creative PEGWorks, we know the importance of quality supplies and ingredients and are dedicated to helping you keep your projects on track with our high-quality products and technical services.

Specializing in PEGylation, polymer modification, particle surface functionalization, and custom synthesis of reactive oligomers and polymers, we’re sure to have the supplies that you need. Visit us at www.creativepegworks.com to request a quote and place your order today.

Posted in Blogs | Leave a comment

Best Practices Found in Good Laboratories

shutterstock_524463343

The Best Laboratory Practices

Certain aspects can get lost in the shuffle when performing day-to-day tasks, especially when you work in an environment that juggles various tasks like a laboratory. That is why having a set of practices is so important. Here are a few of the best practices you will find in the best laboratories around the country.
Maintain Proficiency
While every person in the lab has received the proper education and training to work in the lab, it is also vital that they maintain their level of proficiency despite it all. Be sure to conduct training at least once a year to ensure everyone is on the same page.
Method Validation
Methods change frequently over the years but it is important to validate each and every one to ensure that all who use the method have the same predictable result.
Run Duplicate Testing
Running duplicate, and even triplicate, is to ensure that that the results produce good data,
Document Everything
Organized documents only benefit the laboratory and will give investors, clients, and other organizations confidence in your ability. Remember to keep all original data.

Pegs and Polymers

For all of your peg and polymer needs, look to Creative PEGWorks. We provide custom synthesis, PEGylation, and other contract R&D services, and also has the production capability at kilogram batches . We also provide consulting services for drug delivery and formulation, protein modification, and nanoparticle functionalization.

Posted in Blogs | Leave a comment

FDA approved PEGylated drug

To date, eleven PEGylated proteins, antibody fragments, oligonucleotides, and small molecules have been approved by FDA are on the market, including PEGylated bovine adenosine deaminase: pegademase…

Source: FDA approved PEGylated drug

Posted in Blogs | Leave a comment

How Surfactant PEG are Helping the Drug Industry

 

The Use of Poly and Acrylamide are Allowing Drugs to Easily Reach Their Target

Many people who experience illnesses that require huge doses of drugs often have trouble entering the bloodstream. Researchers have figured out a way to ease this process utilizing Poly and Acrylamide. These biocompatible polymers are water soluble and have the ability to stabilize water-repelling molecules due to their structure being similar to surfactant-like hydrocarbon chains. Learn more about how the PEG-PNIPAM were synthesized in this article.

At Creative PEGWorks, we provide surfactant PEGs for those looking to further their research in the field. For more about our PEG products, please visit our site.

Posted in Blogs | Leave a comment