Global Biotech Laboratories

Overview

Global Biotech Laboratories (GBL) is a contract development and manufacturing organization (CDMO) specializing in peptides, oligonucleotides, and complex biomolecules. The company operates under cGMP and ICH Q7 standards across manufacturing hubs in North America (Boston, San Diego), Europe (Basel, Dublin), and Asia-Pacific (Singapore, Tokyo).

Core Services

Peptide Manufacturing & Synthesis

• Custom peptide synthesis from milligram research quantities to multi-kilogram commercial scale
• Solid-phase and solution-phase synthesis with decades of process expertise
• GMP peptide active pharmaceutical ingredients (APIs) with controlled impurity profiles and stability support
• Phase-appropriate GMP manufacturing from first clinical batch through validated commercial supply

Oligonucleotides

• Therapeutic and diagnostic oligonucleotide manufacturing with rigorous purification and analytics
• Full traceability for next-generation modalities

CDMO Services

• End-to-end contract development and manufacturing: route scouting, process development, analytical development, scale-up, validation, and tech transfer
• Regulatory and CMC documentation support for IND/IMPD and commercial filings
• Engagement models for generic APIs, custom synthesis, clinical/commercial programs, and research supply

Analytical Sciences

• Method development and validation (HPLC, MS, orthogonal methods)
• Stability studies and release testing
• Characterization and quality control

Catalog & Reagents

• Over 1,400 high-purity building blocks, generic peptides, and reference standards
• Same-week global dispatch

Global Distribution

• Temperature-controlled, validated cold-chain logistics with real-time tracking
• Reach to 62 countries with 24/7 follow-the-sun support

Quality & Compliance

• cGMP and ICH Q7 operations across all sites
• ISO 9001:2015 and ISO 13485 certified
• FDA registered and EMA compliant
• USP & EP standards
• ALCOA+ data integrity principles
• Audit-ready documentation and batch records
• Flawless inspection history
• Quality by Design (QbD) principles embedded in process development

Differentiation

• Integrated development, analytics, and manufacturing under one quality system
• Process innovation focused on green chemistry, higher yields, and reduced cost of goods
• Expertise in conjugates, lipidated peptides, and complex oligonucleotides
• Dual-sourcing strategies and supply assurance with 99% on-time delivery
• Seamless scale-up from research through commercial phases