Yuhan Chemical Inc.

YUHAN CHEMICAL

Manufacturing

Process Development

Project Management

Yuhan Chemical has built API manufacturing capability as the core competitiveness since its foundation in 1980.
We have a remarkable comparative edge in process development based on the accumulated experience.

Characteristics of Process Development

Drug discovery

API development

Clinical trials

Launch and
commercialization

Process development

Preclinical

· Synthetic route scouting
· A board range of scale-up possible,
from lab to commercial scale
· Non-GMP supply

Clinical

· Process familiarization studies
· Process safety assessment & simulation for scale-up
· Process development & optimization studies
(optimal parameter ranges & critical parameter
justification)
· Troubleshooting and process modification

Commercial

· Technical transfer to manufacturing plant
· Continuous process improvement for cost reduction

Analytical development

Preclinical

· Analytical method development for IPC &
release tests
· Major impurity identification

Clinical

· Identification & characterization of RS
· Trace analysis (GTI) & impurity profiling
· Forced degradation studies
· MV/MT

Technologies

Crystal Engineering & PAT

· Enhancement of filterability (Particle size & shape)
· Purity & quality control
· In-situ monitoring of particle characterization using FBRM & PVM
· Understanding of the crystallization process

Over 200 Chemical Reactions

Catalytic Reaction ·
Metal catalyzed Hydrogenation (Palladium, Platinum, Vanadium etc.)
Ring-closing metathesis (Grubb’s catalyst)
Enzymatic resolution (Lipozyme, Alcalase, Novozyme)
Cross Coupling Reaction ·
Suzuki coupling reaction ( Pd₂(dba)₂, PdCl₂[P-(t-Bu)₂ph]₂)
Sonogashira coupling ( Pd(ph₂P)₄, Pd(OAc)₂)
Grignard reaction
Others ·
Ozonolysis
Cryogenic reaction (-80℃, n-BuLi, n-Hexyl Lithium)
Thin film evaporation
Ion exchange resin purification
Oxygen concentration control

Process Safety & Simulation

· Basic process hazard review
· Thermal hazard identification (DSC & TGA)
· Process risk assessment (RC1e and iC Safety)
· Physical properties assessment for mixture
· Mixing efficiency & Heat transfer
· OEL (Occupational exposure limits) control

Flow Chemistry (Under Development)

Understanding of flow chemistry ·
Application of flow reaction using in house tubing system ·
Introduction of flow system in 2017 ·
Introduction of flow system for kg scale (2017~) ·