As an integrated CDMO with proven expertise in drug delivery systems, Litchlab also provides end-to-end services for Active Pharmaceutical Ingredient (API) development and manufacturing, helping global pharmaceutical partners bridge the gap from early-stage discovery to commercial supply.
1️⃣ Process Development & Scale-Up
Route scouting and synthetic pathway optimization for complex small molecules.
Quality by Design (QbD)-driven process development with risk assessment and parameter control.
Comprehensive impurity profiling and control strategies (ICH Q3A/Q3B compliant).
Design of Experiments (DoE) for process robustness and scalability.
Patent-avoiding synthetic routes for freedom to operate (FTO) assurance.
2️⃣ Analytical Method Development & Validation
Structural characterization: NMR (1D/2D), HR-MS, FTIR, UV-Vis spectroscopy.
Purity and impurity quantification via HPLC/UPLC, GC, IC.
Residual solvent and elemental impurity analysis (GC-HS, ICP-MS).
Stability studies (accelerated, long-term, photostability) under ICH Q1A guidelines.
Full analytical validation to support IND, ANDA, and NDA submissions (FDA, EMA, NMPA compliant).
3️⃣ GMP Manufacturing Services
Scale flexibility from gram-scale synthesis to kilogram-scale pilot batches and commercial production.
cGMP-compliant facilities, adhering to FDA, EMA, and NMPA regulatory expectations.
Dedicated DMF documentation preparation and regulatory support.
Robust quality system including deviation investigation, change control, and batch traceability.
| API Type | Technical Features | Therapeutic Application |
|---|---|---|
| Small Molecule APIs | High-purity, impurity-controlled synthesis | Generic drugs / NCEs |
| Peptide APIs | Solid-phase and liquid-phase synthesis, site-specific modifications | Injectable formulations / biologics |
| Nucleic Acid APIs (siRNA, mRNA) | High-fidelity oligonucleotide synthesis and chemical modifications | Gene therapy / Vaccines |
| ADC Payload APIs | Custom linker-payload synthesis and purity profiling | Antibody-drug conjugates (ADC) |
✔️ Tailored process development from lab scale to GMP-grade production.
✔️ Comprehensive analytical support across the entire API lifecycle.
✔️ Scalable manufacturing solutions from clinical to commercial supply.
✔️ Seamless collaboration with formulation development for lipid-based and microsphere delivery systems.
✔️ Extensive regulatory experience with global DMF preparation and submission.
📧 Contact: RD1@litchlab.com
📩 Learn more or inquire about a project: www.litchlab.com
