About Hyxtide
Pioneering Peptide Science
Since 2004
A vertically integrated GMP manufacturer trusted by pharmaceutical, biotech, and cosmetic companies across 50+ countries — delivering precision, purity, and partnership.
20+
Years of Excellence
1,200+
Global Clients
50+
Countries Served
40+
Peptide Products
Our Story
Two Decades of Peptide Innovation
From a small Cambridge lab to a globally recognized GMP manufacturer — our journey has been defined by scientific rigor, client trust, and relentless innovation.
“Our founding principle was simple: every researcher and manufacturer deserves access to peptides of the highest purity, delivered with scientific transparency and commercial reliability.”
Dr. James Chen
Co-Founder & Chief Scientific Officer
2004
Founded in Cambridge, MA
Hyxtide was established by a team of MIT and Harvard biochemists with a mission to make high-purity peptides accessible to researchers worldwide.
2007
First GMP Certification
Achieved ISO 9001 and GMP certification for our first dedicated synthesis suite, enabling supply to regulated pharmaceutical clients.
2010
FDA Registration & Global Expansion
Registered with the U.S. FDA as an API manufacturer and began exporting to Europe, Japan, and Australia. Client base grew to 300+ companies.
2014
New 120,000 sq ft Campus
Opened our state-of-the-art manufacturing campus with 8 dedicated synthesis suites, analytical labs, and cold-chain logistics center.
2018
OEM & Private Label Launch
Launched full-service OEM and private label programs, enabling brands to bring peptide-based products to market under their own identity.
2022
ICH Q7 Compliance & 50+ Countries
Achieved ICH Q7 compliance for API manufacturing and expanded distribution to 50+ countries, serving 1,200+ pharmaceutical and biotech clients.
2024
Next-Gen Peptide Platform
Launched our proprietary continuous-flow synthesis platform, reducing lead times by 40% and enabling production of complex long-chain peptides at commercial scale.
Quality & Compliance
GMP Certifications &
Regulatory Compliance
Every product we manufacture meets the strictest international pharmaceutical standards. Our certifications are not just badges — they represent our commitment to quality at every step.
ISO 9001:2015
Bureau Veritas
GMP Certified
EU GMP Annex 11
FDA Registered
U.S. Food & Drug Administration
ICH Q7 Compliant
International Council for Harmonisation
REACH Compliant
European Chemicals Agency
USP/EP Reference
Pharmacopeial Standards
ISO 9001:2015
Bureau Veritas
Quality Management System for Peptide Synthesis & API Manufacturing
Our QMS covers the full lifecycle from raw material sourcing through final product release, ensuring consistent quality across all batches.
Certificate available upon request
Analytical QC Capabilities
HPLC Purity Analysis
≥98% purity guaranteed by RP-HPLC
Mass Spectrometry
ESI-MS and MALDI-TOF confirmation
Amino Acid Analysis
Full composition verification
Endotoxin Testing
LAL method, <1 EU/mg
Optical Rotation
Chiral purity confirmation
Full CoA Provided
Certificate of Analysis with every batch
Our Facilities
120,000 sq ft of
World-Class Infrastructure
Our Cambridge, MA campus houses everything needed for end-to-end peptide manufacturing — from synthesis to QC to fill-finish to global distribution.
Synthesis Suites
8 dedicated GMP synthesis suites with automated SPPS reactors, capable of producing from 1mg to 10kg per batch.
8 Synthesis Suites
1mg – 10kg Scale
Automated SPPS
Continuous-Flow Option
Leadership Team
World-Class Scientists &
Industry Leaders
Our leadership team brings together decades of expertise from top pharmaceutical companies, research institutions, and global manufacturing operations.
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Dr. James Chen
Co-Founder & Chief Scientific Officer
Ph.D. Biochemistry, MIT
Peptide Chemistry
Drug Discovery
GMP Compliance
20+ years in peptide chemistry and drug discovery. Former Principal Scientist at Pfizer. Author of 60+ peer-reviewed publications on solid-phase peptide synthesis and GLP-1 analogs.
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Dr. Sarah Mitchell
Chief Executive Officer
MBA Harvard Business School, Ph.D. Pharmacology, Stanford
Business Strategy
Global Operations
Regulatory Affairs
15 years leading global pharmaceutical operations. Previously VP of Business Development at Lonza. Expert in scaling GMP manufacturing and building international distribution networks.
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Dr. Kenji Tanaka
VP of Quality & Regulatory Affairs
Ph.D. Analytical Chemistry, University of Tokyo
FDA Compliance
ICH Q7
Analytical Chemistry
18 years in pharmaceutical QA/QC and regulatory submissions. Led FDA and EMA inspection readiness programs for 3 major API manufacturers. Expert in ICH Q7 and EU GMP Annex 11.
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Dr. Elena Vasquez
Director of Process Chemistry
Ph.D. Organic Chemistry, ETH Zurich
Process Chemistry
Scale-up
Flow Synthesis
12 years specializing in continuous-flow synthesis and scale-up chemistry. Developed proprietary synthesis protocols for 15+ commercial peptide APIs. Expert in complex long-chain peptide manufacturing.
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Michael Thompson
VP of Global Sales & Business Development
MBA, Wharton School of Business
Business Development
Key Accounts
Supply Chain
10 years building pharmaceutical supply chain partnerships across North America, Europe, and Asia-Pacific. Manages relationships with 200+ key accounts including top-20 pharma companies.
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Dr. Priya Sharma
Head of Formulation & Fill Services
Ph.D. Pharmaceutical Sciences, University of Michigan
Formulation
Lyophilization
Sterile Fill-Finish
14 years in pharmaceutical formulation development and lyophilization. Expert in peptide stability, excipient selection, and sterile fill-finish operations for injectable and topical dosage forms.
180+
Team Members
60+
PhD Scientists
200+
Publications
35+
Patents Filed
Partner With Us
Ready to Work With a
Trusted GMP Partner?
Whether you need catalog peptides, custom synthesis, or full OEM manufacturing — our team is ready to support your project from inquiry to delivery.