R&D
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Runze Pharmaceuticals (Suzhou) Co.,Ltd.(formally known as Synasia Suzhou co.,ltd),established in 2003 in the magnificent city of Suzhou China,is engaging in the research,development and manufacturing of specialty chemicals,pharmaceutical intermediates,active ingredients and dosage forms.The company is subsidiary of Shandong Ruiying Pharmaceutical Group(SRPG),one of Top 100 pharmaceutical companies in China with headquarters in Heze,Shandong.Led by a group of pharma veterans from the US pharmaceuticals industry,our R&D offers a wide-range integrated service including:

Customs chemical synthesis

Route scouting, process optimization,scale-up & piloting,and analytical development

Custom biocatalyst & fermentation development;

Gene engineering, protein expression & purification, fermentation and enzyme development, and

Custom formulation development:

Immediate and controlled release of tablets, capsules and granules.

 

Our R&D Team

Our professional team is composed of over 40 experienced and fully credentialed scientists and engineers (10% Ph.D., 50% M.S.and 40% B.S.) working collaboratively in state of the art labs equipped with advanced instruments. our full-time and devoted professionals provide cost effective,timely and high quality services from R&D to commercial manufacturing for pharmaceutical and biotechnological companies worldwide.

 

Integrated CRO & CMO Services

 Our R&D activities have expanded rapidly in recent years.Our process R&D teams cosist of more than 20 well-trained organic and analytical chemists with hundreds of years of combined industrial experience.Operating under a sophisticated project management system, our teams work tirelessly in R&D labs and multi-functional pilot plants to deliver unsurpassed quality results that our clients deserve on time and on budget .we work with domestic and international clients to meet their needs for synthesized or fermented compounds for pre-clinical, clinical or commercial use in a quantity ranging from grams to multiple tons. CRO services include:

Route scouting for exiting or novel NCEs

Development of Scalable synthetic routes Strain design,screening and development
Process optimization to reduce cost and increase efficiency
Chemical/fermentation scale-up to a robust and safe process
Reference standard preparation
Impurity structure identification & characterization
Polymorph screening
Delivery of compounds from grams to kilograms quantity

 GMP/NON-GMP Contract Manufacturing

Taking full advantage of our parent company’s strength in GMP/non-GMP manufacturing, we are capable of integrating your requirements for early development and late development,whether your demand is for key raw materials,intermediates or APIs.We strive to be in a true partnership with you in various stages of drug development.Our CMO services include:

 NON-GMP or GMP manufacturing of key raw materials

Intermediates & APIs

Large-scale fermentation piloting and commercial production

Full process safety and hazard assessment

Delivery of materials from kilograms to multiple tons in quantity.

Our capabilities & Facilities

Runze (Suzhou) R&D center is one of the three R&D centers within SRPG. With support from our parent company,our R&D,as well as our manufacturing capabilities have been greatly enhanced:

R&D Capabilities

Chemical Labs

Halogention reaction

Phosgenation reaction

Acylation reaction

Ozonization reaction

High & low temperature reactions

High-pressure reaction

Route scouting,optimization & lab scale-up studies

 

Biological & Fermentation Labs

Gene engineering

Protein expression & purification

Enzyme development
Selective breeding& preparation strains

Strain validation

Fermentation process development & scale-up

 

Analytical Development Labs

Analytical method development & validation

Impurities studies

Reference Standards characterization

QC release testing

Major analytical equipment:

Agilent HPLC

Agilent GC

UV/IR

NMR(SHARE)

GC/MS(SHARE)

LC/MS(SHARE)

FTIR(SHARE)

Manufacturing Capacities at company’s headquarters

Synthesis plants

Glass-lined reactors 48x2,000-12,500L

Distillation columns 6x

S.steel storage tanks 48x5,000-50000L

Membrane filter press 10x50-150 m2

Chlorination equipment 2x

Helical condenser/dryer 7x

Film evaporator 7x

 

Fermentation plants

Fermentors 6x200m3

Downstream processing

Ceramic membrane

Resin separation columns

Nano concentration

Spray Drying

Honeywell HC900 hybrid controller