CMC Pharmaceutical Dl tS iDevelopment Services - CPhI … Gateway CMC Pharmaceutical... · CMC Pharmaceutical Dl tS iDevelopment Services ... Over 675 CMC Development pr ojects completed

CMC Pharmaceutical D l t S iDevelopment Services

CONFIDENTIAL© 2015 China Gateway Pharmaceutical Development

Pharmaceutical Development: A New FacilityPharmaceutical Development: A New Facility

A Pharmaceutical Development Center Fengxian, Shanghai Designed by Foster Wheeler U

S

WT Designed by Foster-Wheeler cGMP compliant

Facility Pilot Plant 5251 m2

PPR&D

U

KL

WT

Pilot Plant 5251 m(including cyrogenic and hydrogenation/pressure)

Kilo-Lab 5260 m2

Admin / R&D Lab 14690 m2

Utilit B ildi 2823 2 Utility Building 2823 m2

Warehouse 3480 m2

Flammable/Cold 748 m2

Waste Water Treatment 1100 m2

T l 18893 2 * Total: 18893 m2

Equipment Installation and Qualification

Kilo-Labs and Pilot Plant fully GMP *


operational September, 2011

2

Pharmaceutical Development: Overview

Strategy Provide full pharmaceutical development servicesFocus on early phase development from NCE selection to FIH to Phase IIa

People

Senior management team with average of >13 years of global pharmaceutical experience

85 chemical development chemists70 analytical and formulation scientists

Customers

120 engineers, operators and supporting staff

Over 260 international and domestic Pharmaceutical, biotechnology, virtual, fine chemical

Chemical Development & Manufacturing cGMP Kilo-Lab Suites / Process R&D labs cGMP Pilot Plant with 48 reactors (5 – 6,300 L)

Facilities Analytical Development 19,055 ft2 (1920 m2) lab/office space*

Formulation Development 7,000 ft2 (800 m2) lab/office space*


Business Model FTE / FFS / Production Management

3

Pharmaceutical Development: Process Development

FFS/FTE Projects Over 675 CMC Development projects completed to date Projects ranging from R&D to full scale manufacturing of >3 MT of advanced intermediates Completed 25 cGMP campaigns to date to meet customer needs for clinical grade API, including 12

International based customers (US, Europe, Japan and Taiwan)

Process Research, Development, and Optimization Process development of discovery routes into robust manufacturing processes suitable for intended purpose Process development of discovery routes into robust manufacturing processes suitable for intended purpose

• Replacement of column chromatography with precipitation/crystallization• Implement appropriate, robust IPCs for reaction,

determining ratio of solvents for any solvent swaps and completion of drying• Replacement of use of drying agents with azeotropic drying• Avoid concentration to a residue• Target “fit-for-purpose” volumetric efficiency• Avoid use of non-Pilot Plant friendly solvents/reagentso d use o o o a e d y so e s/ eage s• Avoid use of expensive reagents• Identify appropriate ranges for key processing parameters, including stress testing of the reaction, work-

up, isolation and drying conditions to develop a “fit-for-purpose” manufacturing route• Determine appropriate “fit-for-purpose” acceptance criteria for key starting materials and intermediates


Determine appropriate fit for purpose acceptance criteria for key starting materials and intermediates

4

Pharmaceutical Development: Process Development

Process Research, Development, and Optimization (Continued) Route scouting / selection for new scalable processes, including generation of innovative solutions to complex

synthetic problems Critical process parameter evaluation / justification Technology transfer to manufacturing production Safety evaluation / hazard assessment, including calorimetry

R h d D l t M f t i Research and Development Manufacturing Advanced Intermediates, Registration Starting Materials and APIs Process development support for commercialization Up to metric tonne scale

Custom Synthesis Drug discovery & Preclinical development support

• Impurity markersC t• Comparators

CMC CTD Support Registration Starting Material Strategy Impurity management – fate and linkage


Impurity management – fate and linkage Potential Genotoxic Impurity Management

5

Pharmaceutical Development: Manufacturing Facility

Filter Dryer

CONFIDENTIAL© 2015 China Gateway Pharmaceutical Development 6

Filter Dryer

Pharmaceutical Development: Pilot Plant Overview

Total Area: 5251 m2

Building Height: 18 m with 3 levels

9 Individual Processing Bays, Including 4 Special Bays and 2 Clean Rooms (Class 100,000)

48 Reactors (5 to 6,300 L, total 72 m³)

DCS Control, 1 Bay with Recipe Control

Reaction Temperature: -80 to 300

Reaction Pressure: -0. 1Pa to 10MPa (95 Atm)


Pharmaceutical Development: A New Facility – Bay 4

• R-0341 1000 L SS• R-0342 1000 L GL

R 0343 500 L GL• R-0343 500 L GL• R-0344 500 L GL• F-0341 DN 600 Halar Coated

(10 kg/load)• D-0341 300 L Titanium

(24 Trays)



• R 0361 1000 L GL 3rd Floor

DCS Recipe Control

• R-0361 1000 L GL 3rd Floor• R-0362 1000 L GL 3rd Floor• R-0363 1000 L GL 3rd Floor• R-0356 6300 L GL 2nd Floor• R-0364 3000 L GL 2nd Floor

R 0365 3000 L GL 2 d Fl• R-0365 3000 L GL 2nd Floor• R-0366 1000 L GL 2nd Floor • F-0361 DN800 Halar Coated

(30 kg/load)• D-0361 500 L SS Twin Cone



Cryogenics: -80ºC to 80ºC

• R-0383 300 L SS

y g

• R-0384 500 L SS• R-0385 2000 L SS• R 0386 5000 L SS• R-0386 5000 L SS• Liquid Nitrogen Cooling• Cryogenic TCU Control



Pressure Bay

• R-0373 5 L SS

(For Pressure Reactions including hydrogenation & carbonylation)

R 0373 5 L SS (to 350ºC, 95 Atm)

• R-0372 50 L SS(t 350ºC 95 At )(to 350ºC, 95 Atm)

• R-0371 500 L Hastelloy C276 (to 180ºC, 76 Atm)

• R-0376 3000 L Hastelloy C276(to 140ºC, 57 Atm)


Pharmaceutical Development: A New Facility –Clean Room 2 Finishing Area

Class 100,000 : 100 Kg Batch Size

R-0368 1000 L GL (Crystallizer)

R 0369 500 L GL (C t lli )

g

R-0369 500 L GL (Crystallizer)

F-0362 DN600 SS Horizontal

Centrifuge

D-0362 500 L Titanium Twin Cone

Jet mill 3 to 5 Kg/Hour


Pharmaceutical Development: A New Facility –GMP Kilo-Lab Suites

Each Kilo-Lab Suite Equipped with:100 L Gl Li d R t 2• 100 L Glass Lined Reactors: 2

• 50 L Glass Jacketed Reactor(ChemGlass): 3(ChemGlass): 3

• TCU Control• Centrifuge DN300: 2• Vacuum Tray Dryer, 5 Kg/Batch: 2

Clean Room 3• Class 100,000• 5 Kg Batch Size


Pharmaceutical Development: Typical Projects

Project Code Client Location

Project Description

Type of Compound

Total Amount

Number Steps Comment

CG428 USA API 30 kg 3 GMP for Phase I/II clinical trials, chiral epoxide openingchiral epoxide opening

CG467 USA API 2 Kg 2 GMP for Phase I clinical trials,acid chloride coupling

CG510 USA API 30 Kg 5 GMP for Phase I clinical trials, Pd couplingPd coupling

CG502 USA/China API 2 x 50 Kg 9 GMP for Phase I/II clinical trials,

Pd coupling and hydrogenation

CG498 E API 10 K 8 GMP Chiral SFC separation forCG498 Europe API 10 Kg 8 GMP Chiral SFC separation for an advanced intermediate

CG319 USA API 3.5 Kg 14

GLP Tox Study,Enzyme resolution/ 78C Simmons Smith-78C Simmons-Smith Cyclopropanation

CG427 USA API 3 Kg 14GLP Tox Study,

Suzuki coupling, Chiral CBS reduction


reduction

Pharmaceutical Development: Typical Projects Cli t P j t T f T t l N bProject Code Client

LocationProject

DescriptionType of

Compound Total

AmountNumber Steps Comment

CG480Europe Nitro Aromatic

RSM 3400 Kg 1Alkylation, Included in

Registration Dossier for a marketed productmarketed product

CG459 USA Chloroquinol RSM 150 kg 6 Nitration, hydrogenation

CG204 USA Aromatic RSM 350 Kg 9 Aromatic nitration, LDA mediated aromatic methylationmediated aromatic methylation

CG371USA Isooxazole

Advanced Intermediate

1500 Kg 9 Ellman sulfinamide chiral chemistry

CG397 USA P l li RSM 600 K 6 Low temperature couplingCG397 USA Polycylic RSM 600 Kg 6 Low temperature coupling reaction, intramolecular D-A

CG383 EuropeAldehyde Advanced

Intermediate150 Kg 5 Chromium oxidation,

TEMPO bleach Oxidation

CG448 USA Chiral amine RSM 200 Kg 6 Chiral epoxide opening,

morpholine formation

CG400 USA Long chain diacid 2 x 250 Kg 3

Olefin metathesis reaction, high temp green hydrolysis

( oC)


diacid (>230oC)

Pharmaceutical Development: Typical Projects

Project Code Client Location

Project Description

Type of Compound

Total Amount

Number Steps Comment

CG372 USAAldehyde Advanced 500 Kg 5

Cryogenic o-lithiation. Peracetic oxidation, USA

Intermediateg ,

Cryogenic DIBAL reduction

CG426 Europe Boronic acidIntermediate 50 Kg 2 Cryogenic reaction using BuLi

CG419 USA Fluoro Sugar RSM 100 Kg 9 Low temperature Wittig;

fl i ti tiCG419 RSM 100 Kg 9 fluorination reaction

CG482 USA RSM 1200 Kg 2 Esterification and Iodination

CG418 USA Skin Care 600 Kg 8 Enzymatic resolution; CG418 Product 600 Kg 8 Dynamic Kinetic Resolution

CG432 USAAmine

Advanced Intermediate

22 Kg 2 SNAr

Hydrazine reduction peracidCG429 USA Cyano-

azaindole 34 Kg 5Hydrazine reduction, peracid

oxidation and TMSCN cyanation

CG456 USAChiral

Advanced 26 Kg 7 Dynamic Kinetic Resolution


Intermediate

Pharmaceutical Development: Analytical Development FFS/FTE Projects Stand alone and support for Process Development and Plant

campaigns, including GMP campaigns

In Process Controls In-Process Controls Method development and testing

Residual solvent analysis

Moisture content testing (KF titrations)o stu e co te t test g ( t t at o s)

Compendial testing (HM, ROI)

Counter-ion (ion-chromatography and titration)

Assay Method Development Impurity Characterizations Structural identification

Isolation

Impurity profiling

Release Testing Starting materials

Intermediates


Intermediates

Results of Analysis

17

Pharmaceutical Development: Analytical Development

Method Development: Chromatographic: HPLC, GC Non-chromatographic: wet chemistry spectroscopic etc Non-chromatographic: wet chemistry, spectroscopic, etc.

High Throughput Analysis and Purification HPLC with various detection techniques (DAD/MS/ELSD/CAD) Mass-directed autopurification P HPLC TLC d fl h h t h Prep-HPLC, prep-TLC, and flash chromatography

Structural Characterizations Mass spectroscopy: LC/MS, GC/MS, LC/MS/MS NMR: 1H-, 13C-, 19F-, 31P-, NOESY, DEPT, HSBC, HMQC, etc. FT-IR, UV, elemental analysis, counter-ion analysis, etc.

Physical Characterizations Physicochemical constant: pKa, logP/logD, melting point, etc. XRPD, TGA, DSC, DVS, particle size, etc.

Chemical Characterizations and General Testing Purity, residual solvents, KF titration, Heavy metal, ROI, LOD, etc. HPLC, GC, LC/MS, GC/MS, titration, ion chromatography, atomic absorption HPLC/CLND HPLC/FLD


HPLC/CLND, HPLC/FLD Impurity isolations and characterizations

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Assay MethodsDrug Substances

Method Development Specificity

Identification (NMR, MS, IR, HPLC retention)

Purity and impurities (HPLC, LC-MS)

Residual solvents (GC, GC-MS)

Enantiomeric purity (e e )

No background interference Selectivity of columns

Chromatographic method Stability indicating

Enantiomeric purity (e.e.)

Counter-ion (IC, titration)

Compendial testing (HM, ROI, LOD)

Moisture content (Karl Fisher titration)

Forced degradation Recovery

Chemical Characterizations Impurity identification( )

Drug Products Identifications

Potency/Label Claim

Impurity identification Impurity profiling pH profile Degradation products Degradation mechanism/pathway

Moisture content

Dissolution

Content uniformity

Degradation mechanism/pathway Excipient compatibility

Stability Degradation

Di l ti


Dissolution

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Drug ChemistryForced DegradationForced Degradation

Solid state (heat, heat/HR, light)

Solution state (water, acid, base, 0.3% H2O2, light)

pH profile (pH 2 - 10)p p (p )

Formulation media (0.5% HPMC, PEG, 20% HPBCD, etc)

Up to 2 weeks

Characterizations

HPLC and orthogonal methods

Degradation products by LC-MS

Proposed structures

Degradation mechanism

Impurity profiles



Stability Management

Drug substances and products

Clinical supplies

Protocol driven

Customer defined report format

Stability indicating HPLC method development

Chamber IQ/OQ and calibrations

Storage at: Long term Intermediate Accelerated

CZ I + II 25C/60%RH or30C/65%RH or30C/75%RH*

30C/65%RH or 30C/75%RH*

40C/75%RH

CZ III + IVa 30C/65%RH or 30C/75%RH*

- 40C/75%RH

CZ IVb 30C/75%RH - 40C/75%RH

Refrigerator 5C - 25C/60%RH


Freezer - 20C - -

21


Method Validation

Preliminary

Regulatory submissions (IND/IMPD, NDA/MAA)

Reference Standard Qualification Appearance (USP) ID (by HPLC and IR) pH (USP)Regulatory submissions (IND/IMPD, NDA/MAA)

Drug Product Development Support

Method development

Excipient compatibility

pH (USP) Assay (stability indicating method) Related Substances Residual Solvent (GC method) C t I (I Ch t h )Excipient compatibility

Formulation screening

Accelerated stability

Method Transfer

Counter Ion (Ion Chromatography) Heavy Metal (USP) Metals (GFAA) Residue on Ignition (USP) Method Transfer

Originating/receiving laboratory

Routine Sample Analysis

Identity confirmation

Water Content (KF) X-Ray Diffraction (XRD) NMR Single Crystal XRD Identity confirmation

Purity determination/verification

Conformational testing

Customer defined or in house developed methods

Single Crystal XRD Elemental Analysis High Resolution Mass Spectrum UV/Vis H i it (DVS)


Customer defined or in-house developed methods Hygroscopicity (DVS) TGA/DSC

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Solid State Characterizations Crystallinity XRD Th l l i (TGA/DSC h t t i )

Solution State Characterizations

HPLC Methods XRD, Thermal analysis (TGA/DSC, hot-stage microscopy)

Particle Size Measurement

Morphology Polarized microscope

Evaluation Development

Solubility Profile Ambient pH (1 – 8) Polarized microscope

Size, shape, birefringent

Hygroscopicity Water sorption/desorption isotherm

p ( ) Simulated fluids Organic solvents

Effect of Additives in Aqueous Media Ionic strength Dynamic vapor sorption

Stability Accelerated study Crystallinity and forms

Ionic strength Buffers Surfactants Cyclodextrins in aqueous systems

y y

Milling Effect Microscope, DSC, XRD

Stability pH (1 – 8) for 24 h Degradations Stability enhancement strategies


Pharmaceutical Development: Chiral Separations

Analytical Method Development

Reaction monitoring and e.e. determination

Fast/Automatic HPLC and SFC condition screening

Optical rotation and specific rotation determination

Enantiomers identification (HPLC/SFC)Enantiomers identification (HPLC/SFC)

Enantiomeric Separations

Supercritical fluid chromatograph

Preparative HPLC

Capability from mg to kg

Generally, > 80% recovery, 95 ee%Generally, 80% recovery, 95 ee%

Other Separations

Regioisomers


Diastereomers

24

Pharmaceutical Development: Pharmaceutical Sciences

Physical Characterization and Form Definition

Salt and polymorph screening

Solubility

Solution and solid state stability

pKa/Log D/Log P determination pKa/Log D/Log P determination

Physical Properties for Formulation Development

Flowability

Particle size and size distribution

Bulk and tap densities

Drug Discovery Support for Candidate Selections

Pharmaceutical profiling

Developability assessment


Pharmaceutical Development: Pharmaceutical Sciences

Salt Screening

Commonly used pharmaceutical salts

Solubility

Polymorph Screening

Screening Evaporation anti-solvent cooling slurry Solubility

Aqueous media

Crystallinity Thermal analysis (TGA/DSC, hot-stage

microscopy)

Evaporation, anti-solvent, cooling, slurry Crystallization in single and binary solvents

Crystallinity XRD as primary toolmicroscopy)

XRD

Morphology Polarized microscope Size shape birefringent

Thermal analysis, if needed

Solubility Aqueous media

Size, shape, birefringent

Hygroscopicity Water sorption/desorption isotherm

Hydrate formation possibility

Selected Form Repeat at larger scale Crystallinity Morphologyy p y

Water slurry, 24 hours

Counter Ion Content Ion chromatography

p gy Hygroscopicity Stability


Solubility HPLC

26

Pharmaceutical Development: Formulation Development

FFS Projects Projects include formulation development and manufacture of

DP supplies for clinical studiespp

Preclinical Formulation Development IV/oral liquid formulations for PK , pharmacology, and non-GLP tox studies Integration with internal drug discovery capabilities in Medchem Biology DMPK and Integration with internal drug discovery capabilities in Medchem, Biology, DMPK, and

Toxicology Use up-to-date technologies to optimize preclinical formulations to support drug discovery

programs

Technologies for Poorly Soluble Compounds SEDDS formulation Nanosuspension (wet media milling)Nanosuspension (wet media milling) Emulsion, microemulsion, lipid based complex and micelle formulation Solid Dispersions: amorphous form with carrier matrix Solubilizing Agents: cyclodextrins, surfactants, polar organic solvents


Solubilizing Agents: cyclodextrins, surfactants, polar organic solvents

27


Early Phase Clinical Formulation

Powder in Capsule (PIC)

Powder in Bottle (PIB)

Tablet

Li id f l ti Liquid formulation

Oral Solid Technologies

Wet granulation (high shear, fluid bed,

extrusion spheronization)

Dry granulation (roller compaction)

N i i d lid d f i Nanosizing and solid dosage form conversion

Encapsulation, tableting and film coating

0.1 - 5 kg capacity



Formulation Selection Based on

BCS Class

Clinical needs (Oral/IV, immediate/controlled release)

Bioavailability (conventional or enabled) Bioavailability (conventional or enabled)

Dose strength

Single or multiple dose

Drug stability

Dissolution speed

FIH D /C l St th S l ti FIH Dose/Capsule Strength Selection

Common Blend to Cover wide Dose Range

Forced Degradation and Excipient Compatibility


g p p y

29


Fast release system

Tablet, Capsule, Softgel, Orally Disintegrating Tablets, Dispersible Tablets, Effervescent T bl t Ch bl T bl t G l D S i tTablet, Chewable Tablets, Granules, Dry Suspension, etc.

Controlled release system Matrix Membrane controlled Multi-particulate system Osmotic pump system Mini-Tablet in capsules, Multi-layer tablet, etc.

Enabling technology Nano-suspensionp Solid dispersion SEDDS Co-solvents; surfactants; cyclodextrins; etc.


Pharmaceutical Development: Quality Assurance

Assures overall compliance

Review and approval

cGMP Kilo Lab

A l ti l &

Review and approval

- Change control

- Batch record review

Operation QA

Analytical & PharmaceuticalDevelopments

- Annual product review (APR)

Qualification and validation

Deviation, investigation and CAPAR&D

Manufacturing

Deviation, investigation and CAPA

Compliant handling

Material status control

cGMP Manufacturing Internal and external auditing programs

Management review

Training


g

31

Fengxian QA & EHS Audit Summary Over 35 QA & EHS Audits have been carried since 2011

Auditors include CFDA, “Big Pharma” and specialists including Beckloff Associates and Intertek CFDA Audit Summary

Fengxian GMP Manufacturing Facility has received “Drug Manufacturing Certificate” in 2012 2013 Fengxian GMP Manufacturing Facility has received Drug Manufacturing Certificate in 2012, 2013 and renewed in 2015

China Gateway has applied for several “GMP Drug Manufacturing Certificate” for several APIs manufactured under GMP at the Fengxian site

T E “QP” A dit Two European “QP” Audits Carried out by NNE “QP” auditors and Customer QP auditor according to EMA GMP, Eudralex

Vol. 4, Part II, ICH Q7A and relevant guides using an audit approach similar to FDA’s 6 system inspection approach

Conclusion: Fengxian site is in compliance with EMA regulations to manufacture GMP batches suitable for use in clinical studies in Europe

QA Audit Summary No Critical Observations All “Major” and “Minor” Observations have been addressed

EHS Audit Summary 1 Critical Observation which has been addressed (installed dedicated Air Breathing Supply

system)


y ) All “Major” and “Minor” Observations have been addressed

32

Quality Management for Analytical Laboratories

Quality management Change control Complaint handling Internal and external auditing Employee Training and qualification Job Description of individuals

Non-conformance Deviations/OOS/OOT/Investigation CAPA

Instrument/equipment qualifications Review and approve Qualification protocol and reports Review and approve Qualification protocol and reports Review and approve Calibration certificate

Contract laboratory audit Document controls

SOP creating revising reviewing approving issuing using retaining withdrawing and abolishing SOP creating, revising, reviewing, approving, issuing, using, retaining, withdrawing and abolishing Document change control

Review and approval Protocols and reports S ifi i & COA f l i


Specifications & COAs of release testing Notebook and raw data traceability and integrity audit

33

Pharmaceutical Development: cGMP Project

Process for the delivery of GMP products

Lab experiments will be carried out based on available procedures and then set up BPR for GMP campaign

Chemistrycampaign.

The BPR and specs will be submitted to customer for the review and approval.

Test and release raw materials, intermediate under GMP control.

Execute the GMP campaign

BiologyToxicology

Execute the GMP campaign

Test and release final batch under GMP control

Delivery final products with COA to customer

Submit the executed BPR to customer

DMPK

Submit the executed BPR to customer

Technical Reports

Per customer’s requests, IND readiness reports include:

Analytical Reports (These should include method development, method validation, reference standard DMPK

y p ( p , ,qualification, etc)

Process development report

Campaign report (cGMP manufacture, etc.)


Stability report

34

2. Infrastructure and Operations2. Infrastructure and Operations


Infrastructures & Operations: EHS System

Three Levels of EHS Management Systems

Level 1: corporate EHS policy and goal

L l 2 t d d EHS t d (SMP) Level 2: standard EHS management procedures (SMP)

Level 3: standard EHS operation procedures (SOP)

EHS Organization

EHS department: 10 people dedicated team dedicated to EHS training daily lab EHS inspection EHS department: 10 people dedicated team dedicated to EHS training, daily lab EHS inspection, SMP/SOP drafting, EHS process control

ShangPharma safety committee (SPSC): over 120 scientists working together with EHS dept on internal EHS training, weekly EHS audit, and SOP drafting. Forming sub-SPSC committee focusing g, y , g g gon Process Chemistry and CMC to implement SOPs and auditing

Quarterly EHS audit, EHS management system review, EHS training for management team, EHS department and SPSC

Training, Inspection and Audit

Control and Management

Lab chemicals, equipment / facilities, biohazard materials, etc.


Infrastructures & Operations: IP

Corporate practice

Clients owns all data and IP

Confidentiality clauses in each contract

Company policies

Frequent training programs including LNB recording

SOPs in place for IP protection and notebooks, strict information security regulations

Confidentiality agreement with employees; adherence tied to performance review

Infrastructure

Physical security, including badge access

Disabled duplication function on PCs

Domain / proxy control on local computers; limited Internet access

Segregated data storage based on project and access level

Comprehensive e-security platform to safeguard project information


Infrastructures & Operations: IT Support

Secured Communication VPN connection for e-mail and electronic journals C f EMC e-Room for data sharing with client Selected e-mail encryption programs

Network Security CISCO network firewall / Symantec Norton Anti-Virus systemCISCO network firewall / Symantec Norton Anti Virus system Password protected network and workstation access Restricted physical access to network infrastructure

Literature Support SciFinder, Reaxys, Prous Scientific, Thompson Pharma ACS and SciDirect e-journals

Compound Management and Shipping CambridgeSoft compound management system CambridgeSoft compound management system Shipping document preparation Reliable couriers to guarantee timely delivery


Infrastructures & Operations: Reagent Procurement

Organization

Dedicated staff in Fengxian to handle bulk material requests, led by a senior sourcing manager

Supplier Selection based on Supplier Selection based on

Product quality and selection

Cost and terms

On time delivery On time delivery

Company financial data

Customer services

Supplier Management Supplier Management

New suppliers to provide product samples, license, financial data etc.

Regular onsite auditing

Performance tracking Performance tracking

Order Tracking

IT System to track orders, order confirmation and estimated delivery

For high priority items from oversea ordering, E-mail notification to chemists daily


For high priority items from oversea ordering, E mail notification to chemists daily

Infrastructures & Operations: Shipping Quantities up to 10’s to 100’s of Kg – larger quantities will be case dependent A team of well trained staff Green channel custom clearance Internal shipping tracking system Internal shipping tracking system

US Europe Japan

FEDEX 6 days 7 days 5 daysFEDEX 6 days 7 days 5 days

DHL 4 days 5 days 4 days

World Courier 3 days 4 days 2.5 days

Biocair 5 days 5.5 days

All is calendar day, including time required for flight, normal customs clearance and local land-transport. If th ’ t CIQ i ti 2 3 d d d

LuxAir - 4 days -


If there’s a customs or CIQ inspection, 2-3 more days are needed.

Questions?


Documents

CMC Pharmaceutical Dl tS iDevelopment Services - CPhI … Gateway CMC Pharmaceutical... · CMC Pharmaceutical Dl tS iDevelopment Services ... Over 675 CMC Development pr ojects completed