Peptide API, R&D and Lyophilisation Partner for Europe and the USA

Peptide API and research peptides (RUO)

Every peptide below is supplied for research use only, to research organisations and individual researchers. The five marked API + RUO are also supplied as peptide APIs to pharmaceutical manufacturers. For a sequence that is not listed, see custom peptide synthesis; for GMP programmes, our CRDMO services.

RUO = research use only: not for human or veterinary use, and not for use in medicinal products. The five API + RUO peptides are also supplied as APIs for pharmaceutical manufacturing and R&D.

• Amycretin: what it is, how it works and what studies have found

  Amycretin (INN zenagamtide) explained: unimolecular GLP-1 and amylin receptor agonist, 68-residue structure, phase 1 and 2 data, and the AMAZE phase 3 status.

• Amylin analogues explained: amylin receptors and the peptides that target them

  Amylin analogues and amylin receptor agonists explained: amylin biology, AMY1-3 receptors, pramlintide, cagrilintide, petrelintide, eloralintide and amycretin.

• AOD-9604: what it is, how it works and what studies have found

  AOD-9604 is Tyr-hGH(177-191), a 16-residue growth hormone fragment analogue. Sequence, mechanism, obesity trials, safety data and AOD-9604 vs hGH 176-191.

• Aseptic fill finish explained: how sterile peptide vials are filled, closed and released

  How aseptic fill finish works for peptide vials: terminal sterilisation vs aseptic, filtration, PUPSIT, Grade A/B, isolators vs RABS, media fills, CCI.

• BPC-157: what it is, how it is thought to work and what studies have found

  BPC-157 evidence review: sequence, molecular weight, proposed mechanisms, the rodent studies, the three small human reports, FDA and WADA status, and synthesis.

• BPC-157 vs TB-500: how the two peptides differ in structure, evidence and regulatory status

  BPC-157 vs TB-500 compared: origin, sequence, mass, proposed mechanisms, study counts by evidence level, FDA and WADA status, identity testing and storage.

• Cagrilintide: what it is, how it works and what studies have found

  Cagrilintide explained: long-acting lipidated amylin analogue, sequence, amylin and calcitonin receptor agonism, half-life, and REDEFINE trial findings.

• CJC-1295: what it is, how it works and what studies have found

  CJC-1295 is a GHRH(1-29) analogue; with DAC it binds albumin. Sequence, molecular weight, half-life, human studies, WADA status and the no-DAC form explained.

• What is a drug master file? DMF, ASMF and CEP for a peptide API, with the CTD Module 3 sections

  What DMF stands for, how a Type II DMF works for a peptide API, CTD Module 3 section 3.2.S, GDUFA completeness assessment, LOAs, ASMF and CEP.

• Eloralintide: what it is, how it works and what studies have found

  Eloralintide (LY3841136) explained: selective amylin receptor agonist structure, AMY1R selectivity, half-life, phase 1 and phase 2 data, and ENLIGHTEN phase 3.

• Endotoxin testing for peptides: LAL, recombinant factor C, limits and interference

  Endotoxin testing for peptides explained: how the LAL test works, LAL vs rFC vs MAT, EU/mg limits and MVD, interference, sterility and bioburden tests.

• What is EU GMP Annex 1? The 2022 sterile manufacturing rules explained, clause by clause

  What EU GMP Annex 1 requires: the 2022 revision and its 2023/2024 dates, contamination control strategy, cleanroom grade tables, PUPSIT, lyophilization and APS.

• FDA-approved peptide drugs: a list by INN, approval year, target and length

  FDA-approved peptide drugs listed by INN with first approval year, target and length, plus how FDA defines a peptide, 2020-2026 approvals and trends.

• GLP-1 receptor agonists explained: how they work, the full list, and where research is heading

  How GLP-1 receptor agonists work, a list by INN with FDA approval years, single vs dual vs triple agonists, half-life extension and research directions.

• GMP peptides explained: what GMP grade means, GLP vs GMP, and research grade vs GMP grade

  What GMP grade means for a peptide API under ICH Q7, GLP vs GMP, research grade vs GMP vs pharmacopoeial grade, and when GMP material is needed.

• How to read a peptide COA: every test explained, red flags and how to verify it

  How to read a peptide certificate of analysis line by line: MS identity, HPLC purity, peptide content, water, TFA, solvents, endotoxin, red flags and checks.

• HPLC method validation under ICH Q2(R2) and Q14: a practical guide for peptide purity and assay methods

  HPLC method validation under ICH Q2(R2) and Q14 for peptide purity and assay: specificity, range, accuracy, precision, LOD/LOQ, robustness and SST.

• What is ICH Q11? Starting materials, control strategy and Q6A/Q6B specifications for peptide drug substances

  What ICH Q11 is, how starting materials and control strategy are set for synthetic peptides, where ICH Q6A and Q6B apply, and FDA and EMA peptide guidance.

• ICH Q7 explained: GMP for active pharmaceutical ingredients, chapter by chapter, with peptide APIs in focus

  ICH Q7 explained for peptide APIs: scope, where GMP starts, all 20 chapters, the 2015 Q&A, how FDA and EU inspectors use it, and Q7 vs 21 CFR 211.

• Linaclotide: what it is, how it works and what studies have found

  Linaclotide explained: 14-residue sequence and three disulfides, GC-C and cGMP mechanism, minimal absorption, phase 3 trials, safety and disulfide synthesis.

• Lyophilization services: how to choose a contract lyophilization CMO, and what to send them

  How to choose contract lyophilization services: what to send, cycle development and scale-up, batch and vial formats, release tests and CMO questions.

• Mazdutide: what it is, how it works and what studies have found

  Mazdutide (IBI362, LY3305677) explained: GLP-1/glucagon dual agonist structure, sequence, half-life, GLORY and DREAMS trial data and 2025 China NMPA approvals.

• Net peptide content vs HPLC purity: how amino acid analysis and mass balance measure the peptide in the vial

  Net peptide content vs HPLC purity vs gross weight: amino acid analysis, nitrogen and CHN analysis, Karl Fischer water, counter-ions and stock concentrations.

• What is a peptide bond? Formation, structure, hydrolysis and laboratory synthesis

  What a peptide bond is, how it forms by condensation, why it is planar, cis vs trans, hydrolysis, and how chemists make peptide bonds with coupling reagents.

• Shipping peptides in the cold chain: packaging, dry-ice rules, receiving checks, excursions and long-term storage

  Shipping peptides: lyophilized vs solution, gel packs, dry ice, data loggers, IATA dry-ice rules, receiving checks, excursions and −80 °C storage.

• Peptide counter-ions: TFA vs acetate vs hydrochloride, and why the salt form changes your results

  Why TFA stays on synthetic peptides, how counter-ions change assays and cells, how to exchange them, and what the salt form does to net peptide content.

• How do peptides degrade? Degradation pathways, warning signs and stability testing

  How peptides degrade: deamidation, Asp isomerisation, oxidation, disulfide scrambling, hydrolysis, DKP, pyroglutamate, aggregation and forced degradation.

• Peptide mass spectrometry: how ESI, MALDI, MS/MS and LC-MS confirm a peptide's identity

  Peptide mass spectrometry explained: ESI vs MALDI, charge states, monoisotopic vs average mass, b/y ions, CID/HCD/ETD, peptide mapping and LC-MS reports.

• Peptide modifications for stability and half-life: lipidation, PEGylation, Aib, cyclisation and fusion

  How peptides are engineered for half-life and stability: fatty acid acylation, PEGylation, Aib, D-amino acids, cyclisation, stapling and albumin binding.

• Peptide purification: preparative HPLC, ion exchange and the yield versus purity trade-off

  How peptides are purified: preparative RP-HPLC, ion exchange, mixed-mode, MCSGP, the yield-purity trade-off, salt exchange and lyophilization of the pool.

• Peptide purity testing: how HPLC, mass spectrometry and amino acid analysis work together

  How peptide purity is tested: RP-HPLC columns, TFA vs formic acid, 214 nm detection, LC-MS identity, net peptide content, amino acid analysis and ICH Q2(R2).

• Peptide synthesis: how peptides are made, from the first resin bead to a purified kilogram

  How peptide synthesis works: the Fmoc SPPS cycle, LPPS, fragment condensation, recombinant and enzymatic routes, scale-up, purification, cost drivers and PMI.

• How to reconstitute lyophilized peptides in the lab: solvent choice, stock solutions, storage and troubleshooting

  Peptide reconstitution for in-vitro work: pick a solvent from the sequence, make a molar assay stock, aliquot, store, and fix peptides that won't dissolve.

• Retatrutide: what it is, how it works and what studies have found

  Retatrutide explained: triple GIP, GLP-1 and glucagon receptor agonist, sequence and C20 di-acid, 6-day half-life, phase 2 and TRIUMPH phase 3 findings.

• Retatrutide vs tirzepatide: how the triple and dual agonists compare

  Retatrutide vs tirzepatide: triple vs dual agonism, sequence and linker differences, TRIUMPH vs SURMOUNT and SURPASS results side by side, safety and status.

• Semaglutide: what it is, how it works and what studies have found

  Semaglutide explained: sequence, C18 fatty di-acid side chain, GLP-1 receptor mechanism, one-week half-life, and the SUSTAIN, STEP and SELECT findings.

• Sermorelin: what it is, how it works and what studies have found

  Sermorelin is GHRH(1-29) amide, a 29-residue GHRH analogue. Sequence, molecular weight, GHRH receptor mechanism, FDA history, studies and comparisons.

• Survodutide: what it is, how it works and what studies have found

  Survodutide (BI 456906) explained: glucagon/GLP-1 dual agonist structure, sequence, mechanism, phase 2 and SYNCHRONIZE phase 3 data, MASH studies and status.

• TB-500: what it is, how it works and what studies have found

  TB-500 explained: the Ac-LKKTETQ fragment vs full thymosin beta-4, actin biology, metabolism, published thymosin beta-4 trials, FDA and WADA status.

• Teduglutide: what it is, how it works and what studies have found

  Teduglutide explained: the [Gly2] GLP-2 analogue sequence, GLP-2 receptor biology, half-life, the STEPS trials, safety warnings and regulatory approvals.

• Tesamorelin: what it is, how it works and what studies have found

  Tesamorelin is a 44-residue GHRH analogue with an N-terminal trans-3-hexenoyl group. Structure, half-life, phase 3 trials, NAFLD research and FDA status.

• Tirzepatide: what it is, how it works and what studies have found

  Tirzepatide explained: GIP-based sequence, C20 di-acid, dual GIP and GLP-1 receptor mechanism, 5-day half-life, and SURPASS and SURMOUNT trial findings.

• What is a lyophilized peptide? Freeze-drying explained, from the three stages to the finished cake

  What lyophilized means, the three stages of freeze-drying, lyophilized vs liquid peptides, what a good cake looks like and how GMP sites make them.

• What is a peptide? Definition, types, functions and how peptides are made

  What a peptide is, how it differs from a protein, dipeptides to polypeptides, what peptides do in the body, how they are made, and what research use only means.

• What is WHO-GMP certification? Who issues it, what it covers and how buyers verify it

  What WHO-GMP certification means: WHO GMP texts, the Certification Scheme and COPP, who issues it in India, Schedule M, prequalification, verification.

• CDMO vs CMO vs CRDMO: what is the difference, and which one does a pharma buyer need?

  What CMO, CDMO and CRDMO mean in pharma, how their scope differs, what GMP rules apply to every contract manufacturer, and which model a buyer needs.

• Generic semaglutide: EU and US regulatory pathways, and what API makers must show

  How generic semaglutide is filed in the EU and US: generic vs hybrid, 8+2+1 protection, ANDA vs 505(b)(2), synthetic vs recombinant API, API maker duties.

• How to qualify a peptide API supplier: a documentation and audit checklist for EU and US buyers

  A documentation and audit checklist for qualifying a peptide API supplier for EU and US filings: written confirmation, DMF/ASMF, GMP audit, impurities and agreements.

• Lyophilized (lyophilised) peptide stability and storage: how long a peptide API lasts and how to keep it

  How long a lyophilized peptide API lasts, what degrades it, which storage temperatures ICH Q1A(R2) defines, how stability is tested and how to ship it safely.

• Peptide API impurities and specifications: thresholds, tests and what regulators expect in 2026

  How peptide API impurities are classified and controlled: why ICH Q3A does not apply, Ph. Eur. 0.1/0.5/1.0% thresholds, FDA's 2026 peptide guidance and what a specification covers.

• Peptide lyophilization (lyophilisation): a practical guide to freeze-drying peptide APIs

  How peptide lyophilization (freeze-drying) works: freezing, primary and secondary drying, Tg′ and collapse temperature, excipients, cycles and vials.

• How to read a semaglutide API certificate of analysis (COA)

  A test-by-test guide to a semaglutide API COA: identity, assay, purity, peptide content, water, acetate, residual solvents, endotoxin and the specs behind them.

• Semaglutide patent expiry by country: dates, status and what it means for API buyers

  When semaglutide's compound protection ends in India, China, Canada, Brazil, the US, EU, UK and Japan, with primary sources, and what it means for API buyers.

• Semaglutide vs tirzepatide vs liraglutide: how the three peptide APIs compare

  How semaglutide, tirzepatide and liraglutide APIs differ: backbone, length, lipid chain, receptors, half-life basis, molecular weight, CAS and approval.

• SPPS vs LPPS vs hybrid: how peptide APIs are manufactured, and why the route matters to buyers

  Solid-phase, liquid-phase and hybrid peptide synthesis compared for API buyers: chemistry, length limits, impurities, scale, solvent use and regulatory impact.

• What is a peptide API? API vs drug substance explained

  A peptide API is the active ingredient of a peptide medicine. How ICH, FDA and EU law define API, drug substance and active substance, and where peptides fit.