Teduglutide Research Peptide (RUO)

What is Teduglutide?

Teduglutide is an analogue of human glucagon-like peptide-2 (GLP-2), a 33-amino-acid peptide derived from the native GLP-2 sequence. A single substitution of glycine for alanine at position 2 from the N-terminus confers resistance to degradation by dipeptidyl peptidase-4 (DPP-4), extending its in-vivo half-life relative to native GLP-2. As a GLP-2 receptor agonist it regulates the functional and structural integrity of the intestinal epithelium; in animal and clinical studies it has been shown to increase villus height and crypt depth, expanding the absorptive surface area of the intestine.

As an active pharmaceutical ingredient (API), teduglutide (CAS 197922-42-2, molecular formula C164H252N44O55S, ~3752.13 g/mol) is a lyophilised powder. It is an approved active: the US FDA granted approval in December 2012 and the EMA / European Commission in August 2012, for short bowel syndrome in patients dependent on parenteral support.

How Teduglutide Is Produced & Characterised

Teduglutide is a synthetically demanding 33-mer peptide: its length, the single methionine residue and the closely related deletion and oxidation variants all create real purification challenges. Industrially, peptides of this class are typically produced by Fmoc solid-phase peptide synthesis (SPPS), in which the chain is assembled residue-by-residue on a resin support through controlled coupling and deprotection cycles. The crude peptide is then purified by preparative reversed-phase HPLC, often on dynamic axial compression (DAC) columns, to resolve the target sequence from related impurities and to manage methionine oxidation.

Process controls aim for repeatable batch-to-batch consistency from optimisation runs through to larger campaigns, with controlled lyophilisation yielding a stable, uniform powder. Characterisation of the resulting material commonly combines UPLC/HPLC for purity, LC-MS for sequence and impurity profiling, and assays for water content, counter-ion content, residual solvents and peptide content, reflecting general analytical practice for therapeutic peptides.

Regulatory & Approval Status

Teduglutide is an approved active pharmaceutical ingredient. The US FDA approved it in December 2012 and the EMA / European Commission in August 2012, for the treatment of adults and children with short bowel syndrome who are dependent on parenteral support. As an approved active, it is the subject of established regulatory documentation frameworks, for example US Drug Master Files (Type II) and CTD Module 3 CMC sections used by manufacturers when referencing the substance in IND, NDA or ANDA submissions.

Quality systems for peptide APIs of this type are generally aligned with pre-approval-inspection (PAI) expectations of agencies such as the FDA, EMA and PMDA. Research-grade teduglutide supplied for laboratory use is not the approved medicinal product.

Research supply from Winhycare Pharma

Winhycare Pharma supplies research-grade Teduglutide to research organisations and individual researchers for research and development purposes. Material is supplied at high purity (>99%) under stringent quality control with QC documentation, in secure packaging through global standard logistics, with dedicated technical assistance from our team. We focus on consistent quality and purity, reliable and timely supply, confidential and professional service, and long-term partnerships.

Research use only. Not for human or veterinary use, and not for use in food, drugs, medical devices or cosmetics.

To enquire, tell us the quantity you need, the purity grade, the documentation you require and the destination country. The buyer is responsible for complying with the import and use regulations that apply to Teduglutide in their country.