Products & Services

    尊龙凯时AG(中国区)官方网站

    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
    1. 4 spray dryers covering from lab to commercial scale.
    2. Manufacturing capability for both general and antitumor drugs
    RESPONSIBILITY
    Share Contact Information, Store Details, And
    Brand Content With Your Customers.
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