Tianyu Pharm's CDMO business provides one-stop services from clinical phase I to
commercial production for a wide range of domestic and international pharmaceutical customers.

ONE-STOP CDMO SERVICES:

Phase I

Phase II

Phase III

Registration & Commercialization

RSMs intermediates APIs
Process R&D, Solid State Chemistry
RSMs, Intermediates & APIs Manufacturing
Analytics
Analytical Development, QC, Stability Studies
Regulatory Affairs
Global Regulatory CMC & DMF Filing Support
Drug Products
Pre-formulation Study and Formulation DevelopmentDrug Products Manufacturing

KILO LABS FOR PRODUCTION OF VARIOUS SPECIFICATIONS AT PILOT-SCALE

Location
Kilo Lab Reactor Qty.
Reaction Vo1. (L)
Temp. Range (°c)
Max. Pressure (MPa)
Max. Amount (kg)

Changzhou
R&D Center

2
0.01~20
-78~120
2.0
2

Huangyan
R&D Center

8
10/20
-50~200
0.3
20

Shanghai
R&D Center

6
10/30/50
-45-200
0.1
5

0

+

Chemists

0

Kilo

Labs

CGMP PRODUCTION SITES FOR VARIOUS NEEDS IN COMMERICALIZATION

Tianyu has 5 plants have successfully passed the official inspections conducted by the major drug regulatory authorities from US, EU, Japan, Brazil, Korea, Australia and so on. The company's quality management system is established based on the requirements of ICHQ7, FDA, EU and China's cGMP regulations and guidelines.

Tianyupharm's core technologies include:

Tianyu Pharm has 6 lab-scale reactors for flow chemistry process development. So far Tianyu has developed flow chemical processes for several products and realized commercial productions for diazotization, photo-oxidation, lithiation and nitration reactions by applying flow chemical processes. 

Reaction Type:Photo-Oxidation Reaction

Reaction Type:Photo-Oxidation Reaction

Designed Capacity:1500 mt/yr

Reaction Type:Diazotization

Reaction Type:Diazotization

Designed Capacity:900 mt/yr

Reaction Type:Nitration

Reaction Type:Nitration

Designed Capacity:800 mt/yr

Reaction Type:Lithiation

Reaction Type:Lithiation

Designed Capacity:500 mt/yr

The types of enzymes we currently have and the corresponding reactions that can be developed:

l  Transaminases---Asymmetric conversion of ketones to chiral amines

l  Ketoreductases---Reductions of ketones to chiral alcohols

l  Nitrilases---Asymmetric hydrolysis of nitriles to carboxylic acids

l  Imine reductases--- Asymmetric conversion of ketones/imines/ to chiral amines

l  Monoamine Oxidases---Oxidation from amines to imines with O2 atmosphere

l  Esterases---Efficient hydrolysis from esters to carboxylic acids

l  Acylases---Resolution and formation of esters

l  Nitrile reductases--- Reductions of nitriles to amines


Tianyu can provide enzyme screening services:

l  Tianyu currently has TECAN SPARCK20 microplate reader, which can provide high-throughput enzyme linked reaction screening.;

l  Tianyu has a number of LC-MS and GC-MS equipment that can be used for online screening of enzyme-catalyzed reactions;

l  Tianyu provides Artificial Enzyme Screening Service (FTE).


The types of enzymes that are being expanded and the corresponding reactions :

Acylases---Resolution and formation of esters
Nitrile reductases--- Reductions of nitriles to amines

SPRAY DRYING TECHNOLOGY

CAPABILITIES
1. 4 spray dryers covering from lab to commercial scale.
2. Manufacturing capability for both general and antitumor drugs
CAPACITY
2 commercial spray dryers with the capacity of 20kg/hand 50kg/h (DCM evaporation) respectively
RESPONSIBILITY
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