MayMag Biologics produces clinical-grade lyophilized peptides using validated freeze-drying processes that preserve peptide integrity, potency, and sterility. Our lyophilization capabilities support both development-scale and commercial-scale production, with full ICH-compliant stability data and regulatory documentation.
Download Clinical Grade Lyophilized Peptides Datasheet (PDF)Validated freeze-drying cycles under ISO 5 aseptic conditions for sterile peptide vials, ensuring product integrity and extended shelf life.
Compatibility testing for Type I glass vials, rubber stoppers, and aluminum crimp seals to ensure container closure integrity.
ICH Q1A-compliant accelerated and long-term stability studies for lyophilized peptide products, supporting regulatory submissions.
Validated reconstitution procedures with bacteriostatic water or sterile diluents, with documented reconstitution time and clarity testing.
Full batch records, Certificate of Analysis, sterility testing (USP 71), endotoxin testing (LAL), and potency assay for every lot.
Scalable lyophilization capacity from Phase I clinical batches through commercial production, with technology transfer support.
| Product | Form | Purity | Storage | Description |
|---|---|---|---|---|
| Tirzepatide Analogue | Lyophilized vial | ≥98% | -20°C | GLP-1/GIP dual agonist lyophilized for reconstitution. Clinical and commercial supply. |
| Semaglutide Analogue | Lyophilized vial | ≥98% | -20°C | GLP-1 receptor agonist lyophilized peptide for sterile reconstitution. |
| BPC-157 | Lyophilized vial | ≥98% | -20°C | Tissue repair pentadecapeptide in lyophilized sterile vial format. |
| Thymosin Beta-4 (TB-500) | Lyophilized vial | ≥98% | -20°C | Actin-binding regenerative peptide in lyophilized sterile vial format. |
| Cagrilitide | Lyophilized vial | ≥97% | -20°C | Amylin analogue lyophilized peptide for metabolic disorder research. |
| Custom Peptide Sequences | Lyophilized vial | ≥95–99% (per spec) | Per stability data | Custom GMP peptide synthesis and lyophilization for client-specified sequences. |
Contact our team for lyophilization capacity, batch documentation requirements, stability data, and clinical supply agreements.
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