Global Biologics Innovation Drug Strategic Deployment
The company owns world-leading isolator production lines and high-end sterile injection manufacturing technology. It is one of the few domestic enterprises that have simultaneously obtained quality certifications from the US FDA, EU EDQM, Japan PMDA, Brazil ANVISA, UK MHRA, and other regulatory authorities.
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Nanjing
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Chengdu
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Xentria
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Beverly
Nucleic Acid (mRNA) Drug Process Development and Commercial Manufacturing
Formulation R&D Platform
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R&D & Complex Formulations
Kingfriend’s FDA zero‑483 R&D center offers full formulation services for biologics, high‑end generics, 505(b)(2), and small molecule innovator drugs. We have proven expertise in high‑barrier drugs (light, oxygen, or temperature‑sensitive, potent, non‑aqueous, poorly soluble or easily hydrolyzable) and novel delivery systems (emulsions, micelles, liposomes, nanoparticles, LNP). Our multi‑format injectable platform supports vials, cartridges, and pre‑filled syringes, covering lyophilized and liquid forms, cytotoxic and non‑cytotoxic products, as well as terminal and non‑terminal sterilization.
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Aseptic Manufacturing & Scale‑Up
Kingfriend was the first in China to introduce OEB 5 fully enclosed aseptic barrier isolators for dispensing, formulation, filling, and sterility testing. We use disposable filling systems to achieve complete physical isolation between operators and sterile drugs. Our fully automated production and online monitoring include CIP/SIP, in‑process weighing, environmental monitoring, automated lyo loading/unloading, and automated inspection & packaging. Advanced processes include low‑temperature/low‑oxygen filling and non‑aqueous lyophilization. We offer flexible scale‑up with vial sizes 2–100 mL, lyo capacity 0.5–40 m², and formulation capacity 10–2500 L. Our lines are compatible with disposable and stainless steel systems, significantly shortening project timelines.
