As global drug development accelerates and early-stage pipelines proliferate, Active Pharmaceutical Ingredient (API) services are undergoing a strategic shift—from traditional production models to research-enabling, regulatory-conscious solutions. Litchlab today unveiled its Non-GMP API One-Stop Service Platform, a high-performance offering designed to support biotech and pharmaceutical innovators through every stage of preclinical development and IND-enabling studies.
In modern drug R&D, non-GMP APIs are critical: enabling toxicology studies, mechanism exploration, early formulation trials, and establishing a foundation for seamless transition into GMP manufacturing. However, common outsourcing pitfalls—non-transferable processes, inadequate data packages, and inconsistent batch performance—frequently create costly delays and regulatory risks.
Litchlab addresses these gaps with a fully integrated platform built on the principles of scalability, compliance-by-design, and regulatory alignment across global jurisdictions (FDA, EMA, NMPA). Through cross-functional synergy between synthetic chemistry, analytical development, and downstream formulation compatibility, Litchlab is redefining the benchmark for non-GMP API services.
Platform Highlights
✅ Route Design & Feasibility Assessment
Parallel route screening optimized for scalability, green chemistry, and IP compatibility
Evaluation for GMP transferability, impurity control pathways, and continuous flow potential
✅ Process Optimization & Scale-Up
Flexible supply from milligram to kilogram scale
QbD-based process refinement for yield, purity, and critical process parameters (CPP)
Crystal form screening, solvent/reagent optimization, and impurity profiling
✅ Non-GMP Synthesis & Analytical Support
In-house synthesis facility for toxicology and preclinical-grade API batches
Full suite of analytical tools (LC-MS, NMR, GC, ICP-MS) for structure confirmation and impurity analysis
IND/IMPD-ready technical data packages for regulatory filing
✅ Seamless CMC Integration
Streamlined tech transfer to Litchlab’s GMP manufacturing platform
Integrated support for US, EU, and China IND submissions (CMC Module authoring available)
📈 Industry Landscape: A New Frontier in Early-Stage API Services
According to Evaluate Pharma and BCG, early-phase pipeline growth will reach 10% CAGR from 2023–2028, with biotech startups contributing over 70% of new projects. These companies often face pressure from tight timelines, limited budgets, and evolving CMC requirements—making flexible, registration-ready non-GMP API partners indispensable.
Litchlab’s platform is engineered to serve this demand: bridging early synthesis with later-stage GMP production, and helping clients reduce tech transfer friction, regulatory delays, and cost overhead.
📨 Contact us today to build a globally compliant, cost-efficient, and high-quality non-GMP API solution tailored to your pipeline.
🔗 Learn more: www.litchlab.com
📧 Email: sales@litchlab.com
