NANOGEN PROFILE 2016
25
APIs/Finished Goods Manufacturing & Technology Transfer Services
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Transcript of NANOGEN PROFILE 2016
APIs/Finished Goods Manufacturing
&
Technology Transfer Services
Nanogen BioPharma
- At Glance
NANOGEN 2
NANOGEN
BioPharma
Established
in 2006
Advanced Recombinant
DNA and Protein technologies
Leading Biopharma
Company in Asia Pacific
Products exported to Asia,
Africa, Central America and CIS
regions.
Focus on Bio Similar Mabs for oncology and its related Therapy
API &
Finished Goods
Manufacturing
APIs/ Finished Goods
Manufacturing & TechTransfer
Services
Pharmaceutical Manufacturing Facility
Confidential 3 NANOGEN 3
• Located at Saigon Hi-tech Park of Hochiminh City, Vietnam
• Total area: 15 000 m2 , including:
- Factory 1, WHO-GMP compliant : 5 000 m2
- Factory 2, on process for TGA- GMP, PIC/s-GMP compliant: 10 000 m2
APIs/ Finished Goods Manufacturing
& Technology Transfer Services
Confidential NANOGEN 4
API Manufacturing
Finished Goods
Manufacturing
Technology Transfer
Services
• Single use Bioreactor Technology
• Basal and Feed Medium optimization
• Upstream and Downstream Process
• Formulation Development
• Facility for Liquid Vial, Lyo Vial & PFS
• Aseptic Filling
• Consulting from R&D to Manufacturing
APIs Manufacturing
Process development: Flexibility for different scales from 10L to 500L
manufacturing. Single use technology equipment platform
Quality Control (QC): analytical support including Physico- chemical
characterization, Bioassay method development for biologics
Pharmaceutical Warehouse: GMP compliant facility
Finished Products
Production line: Liquid Vial, Lyophilized Vial, PFS
Automation & Process control: PLC/HMI controller system
Air & Water quality: air filtration (HVAC controlled by BMS) and water distillation
system
Confidential
Cipla BioTec 5
Manufacturing Site - Overview
NANOGEN 5
Quality Control Lab • Biochemistry Lab
• Cell Bioassay Lab
• Microbiology Lab
Finished Product Manufacturing • PFS/ Liquids Vials/ Lyo vials)
• 12-16 million units/ annum
APIs Manufacturing 10L/50L/200L/500L
Single use technology platform
Confidential
Cipla BioTec 6
Manufacturing Site – Overview
NANOGEN 6
Confidential
Cipla BioTec 7
Dedicated Team & Functionality
NANOGEN
NANOGEN 7
Manufacturing Research &
Development (RD)
New
Molecules
SOP
Process
Optimization
Formulation Finished
Product APIs
Quality
Control (QC)
Quality
Assurance (QA)
Biochemistry Microbiology Bioassay
Regulatory
Affairs (RA)
NANOGEN
Drug
Registration
Media-
Medical
GMP-
Standard
Domestic
International
Clinical
trial
Inven-
tion
Business
Single use Bioreactor 200L
Purification clean area
Confidential
Cipla BioTec 8
Mammalian Cell Fermentation: Perfusion/Orbital
Shake/ Wave Bioreactor (10L, 50L, 200L, 500L)
Bacterial Fermentation: Single use technology –
Fermenter (20L, 50L, 200L, 500L)
Facility: design compliance with GMP standard,
equipment with IQ,OQ,PQ controlled
Independent HVAC system: clean area of Grade A-
EU-GMP for Cell culture, Media , Upstream and
Downstream process.
NANOGEN 8
API- Manufacturing Site
Vial washing line with sterilizer
Filling line Formulation line
Dosage form:
Liquid vial, Lyophilized vial and PFS available
Dedicated HVAC system: for Compounding,
Filtration, Filling and Packaging room
BMS system: control and monitor automated
Confidential 9
NANOGEN 9
Finished Product Manufacturing
Manufacturing & Purity
NANOGEN 10
Clean area
Protective Clothing Set Air Shower Pass-Box for clean room
Packaging
Automated Packaging in independent Area
Packaging capabilities are monitored in units/ line
High speed Applicator and Label system
Manufacturing Support Unit
NANOGEN 11
Warehouse System
Dedicated area for raw materials, APIs and finished products
GMP compliant facility for Biologics
GSP controlled system for cold room and deep freezer
Confidential
Cipla BioTec
Quality Assurance (QA) & Quality Control (QC)
Validated document management system
Regulatory submission support (CMC)
Production and Process system controls
Vendor and Material management
Quality management review
CAPA, Change management, Investigation,
OOS, and QRAM
cGMP Documentation
Internal self-assessment audits
Biochemistry Laboratory
Validation for Raw material, In-process and
Finished Product, Stability Storage, Cleaning
Microbiological Laboratory
Test for Microbiological Limit, Bioburden,
Sterility , Bacterial Endotoxin, Microbial Assay
Cell Bioassay Laboratory
Method development, Method Validation, Batch
Release and Stability studies
1
2
NANOGEN 12
QUALITY CONTROL QUALITY ASSURANCE
Confidential
Cipla BioTec 1
3
NANOGEN 13
CURRENT PRODUCTS
Confidential
Cipla BioTec 1
4
NANOGEN 14
FERONSURE (Interferon alfa-2a)
Treatment of Chronic Hepatitis B/C
PEGNANO (PegInterferon alfa-2a)
Treatment of Chronic Hepatitis B/C
NANOKINE (Human Erythropoietin alfa)
Treatment of Symptomatic Anemia
Confidential
Cipla BioTec 1
5
NANOGEN 15
FICOCYTE (Filgrastim)
Treatment of Neutropenia
PEGCYTE (PegFilgrastim)
Treatment of Neutropenia
Confidential
Cipla BioTec
UPCOMING PRODUCTS
1
6
NANOGEN 16
Confidential
Cipla BioTec 1
7
NANOGEN 17
NANERCEPT (Etanercept)
Rheumatoid arthritis
PEGLAMDA (PegInterferon lambda-1)
The novel Molecule for Hepatitis
Confidential
Cipla BioTec
PRODUCTS UNDER DEVELOPMENT
1
8
NANOGEN 18
Confidential
Cipla BioTec 1
9
NANOGEN 19
Biopharmaceuticals
Brand Name Molecule Indications
Pegstat Peginterferon alfa 2b skin cancer (melanoma)
Astapen Bevacizumab colon or rectum cancer
Faceptor Trastuzumab breast cancer
Lotusan Rituximab non-Hodgkin's lymphoma or
chronic lymphocytic leukemia
Feronto Interferon alfa 2b skin cancer (melanoma)
Vibnoxrin Enoxaparin deep vein thrombosis
Fibricin Heparin natri anticoagulant
Stimus Darbepoetin alfa anemia
Confidential
Cipla BioTec 2
0
NANOGEN 20
Brand Name Molecule Indications
Apogem2f Gemcitabine pancreas cancers
Calitaxel Paclitaxel breast cancer, ovarian cancer, and
lung cancer
Emilox Doxurubicin different types of cancers
Forespi Epirubicin breast cancer
Voposid Etoposide small cell lung cancer
Essena Mesna reduces the harmful effects of the
cancer medicine ifosfamide
Flubine Fludarabine phosphate B-cell chronic lymphocytic leukemia
Pharmaceuticals
Confidential
Cipla BioTec 2
1
NANOGEN 21
Brand Name Molecule Indications
Inoplatin-CP Cisplatin bladder cancer, testicular cancer, or
ovarian cancer
LinotalCa Calcium folinate reduces the harmful effects of the cancer
medicine methotrexate
Mediplatin-BP Carboplatin ovarian cancer
Miracel Docetaxel breast cancer, lung cancer, prostate
cancer, stomach cancer
Nanotecan Irinotecan colon and rectum cancer
Xalilatin Oxaliplatin colon and rectal cancer
Mesopem Methotrexate breast, skin, head and neck, or lung cancer
Pharmaceuticals
Confidential
Cipla BioTec
Nanogen’s current Export Markets
2
2
NANOGEN 22
ASIAN MARKET Philippines, Cambodia, Myanmar, Thailand, Indonesia, Bangladesh, India, Srilanka, Pakistan.
CIS MARKET Moldova, Transnistria, Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan, Georgia, Armenia,
Tajikistan, Kyrgyzystan.
AFRICAN MARKET Tanzania, Morocco, Nigeria, Egypt, South Africa
SOUTH AMERICA MARKET Venezuela.
Confidential
Cipla BioTec
Why Nanogen – Your Preferred Partner
NANOGEN 23
Variety of contract services: Contract Manufacturing and Technology Transfers
What we offer:
Proven technology with successful reproduction track record
Complete data package, including safety and efficacy data
Established in-house R&D, RA, QA, and Tech Transfer teams
Complete Formulation & Filling manufacturing, QA/QC, Bioassay, and IPC
Full Drug Master File (DMF)
GMP Process and Analytical Validations
Clinical data
Value Proposition:
International standard value for top-quality therapeutics.
The highly skilled and relatively low-cost local labor force allows us to produce the
same – or better - products at a fraction of the cost while maintaining quality.
Flexible contract manufacturing due to customer requirements.
Looking Forward To Mutually Beneficial Cooperation.
Thank You !
Confidential
Cipla BioTec
NANOGEN
Lot I – 5C Saigon Hi-tech Park, Tang Nhon Phu A Ward, District 9,
Ho Chi Minh City, VIETNAM
Tel: (+84) 8 3730 9931 Fax: +84 8 3730 9963
www.nanogenpharma.com
