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LKtime Biotech (Changchun)

LKtime Biotech (Changchun) R&D Center Drug Substance (DS) production Drug Product (DP) production Quality Analysis and Control Customized CDMO Service

LKtime Biotech (Changchun)

Global Compliant Biopharmaceutical CDMO Service Platform – International Production Capacity + Full Dosage Form Coverage

As a key project under Changchun City's "Changchun Pharma Valley" strategic plan, the production base has a total investment of over 700 million RMB, with a total construction area of 34,000 square meters, including more than 24,000 square meters of production facilities compliant with international GMP standards.

Core Production Capabilities

1. Prokaryotic Drug Substance Platform

- Scale: Full-process production from 20L → 300L → 3300L, with an annual capacity of 480,000 liters

- Supporting Services: Integrated formulation and filling services


2. Eukaryotic Drug Substance Platform

- Flexible Cultivation: Multi-scale production lines with disposable bioreactors (50L/500L/2000L)


3. International Formulation Production Lines

- Topical Preparations: Dedicated production line for sterile gels in aluminum-plastic/aluminum tubes

- Injectables:

- Dual-vial (lyophilized/liquid) production line, supporting multi-format switching (including pre-filled syringes), with an annual capacity of 200 million units

- Dedicated pre-filled syringe line, annual capacity of 8 million units

- Cartridge line, annual capacity of 8 million units

International Compliance Certifications

- Full-System Certifications: GMP approvals from China NMPA, US FDA, EU EMA, and WHO-PQ  

- Global Supply Capability: Compliant with international GMP standards, supporting multinational regulatory submissions and commercial production