mycenax introduction_

From Bench to Better Lives

1 2016MAR Confidential

MycenaxBiotech Inc.

2016 March

• Mycenax in Brief

• CDMO Capability and Capacity for Biologics Development

• Biosimilar Pipeline

• Summary

2016MAR Confidential2

Outline

Mycenax Introduction



Located in Hsinchu Science Park, Taiwan (110 km south of Taipei)

• Company established: Sep. 2001

• Facility built/validation: 2004

• Chairman: Te-Li Chen, M.D., Ph.D

• President: Karen Wen, Ph.D.

• Employees: 121

• Main business activities: CDMO service

Biological product development

• Capital: USD 37 million (NTD 1.1 billion)

• Net sales: USD 4.5 million [NTD 134.9 million, year 2015]

• Listed on the GreTai Securities Market (GTSM), Taiwan # 4726


• Expertise in biologics manufacturing

• PIC/S GMP certified and FDA DMF registered

• Mammalian and Microbial manufacturing according to EMA/FDA/JP/ICH guidelines

• A total service solution from cell line development to aseptic fill/finish

• Disposable technology with up to 2000L scale

• Mycenax has 7 biosimilars in its pipeline and is intensively evaluating bionovel opportunities.

A CDMO provider, Biosimilar Partner & Bionovel Co-developer

Core Competency- Bioprocess


Meeting International Standards & Client Expections


Bionovel

Monoclonal antibody

Therapeutic vaccine

Recombinant protein

Nasal vaccine

Glycoprotein

Transgenic protein

DNA vaccine

Biosimilar

Monoclonal antibody

Fc-fusion protein

Recombinant protein

Peptide

Worldwide partnership

2016/3/21 Confidential8

Bench

Bed Better life

Track Records

Mab-BS

Mab-BS

Registration, TW

Recombinant Protein

Phase I~III, TW/ KR

TuNEX®

Phase I IND, EU/TW

Peptide Drug

GranNEX®

LusiNEX®

MabPhase II~III, US/KR/TW/HK/IN

Oncology Vaccine

Phase II, Global

Recombinant Flu Vaccine

Bionovel

Recombinant protein

Therapeutic vaccine

Monoclonal antibody

Nasal vaccine

Glycoprotein

Transgenic protein

DNA vaccine

Biosimilar

Monoclonal antibody

Recombinant peptide

ProjectManagement

Process Development

Cell line

Upstream (fermentation/

cell culture)

Downstream (purification/

formulation)

Analytical development

PIC/S GMP manufacture

Cell bank production (MCB/WCB)

Upstream mfg.

Downstream mfg.

Stability Study

Quality Assurance

Aseptic Fill/Finish

Vial Filling

Lyophilization

Prefilled Syringe

(PFS)

Characterization

Analysis

Product characterization

Comparability study

CMC writing

CTD package (Module 3)

IND/NDA submission


Total Solution for Protein Drug Development-CMC based platform, Disposable Technology and PIC/S GMP manufacturing

Mammalian system-5, 50, 200, 500, 2000LMicrobial system- 5, 50L


200L Model Establishment

Confirmation (CQA)Testing run (KPP)

500L Model Establishment


2,000L Model Establishment


Upstream Process Development-Scale up to designate process

5L Bioreactor Model

Establishment

Medium/Feed selection

Process optimization

Feeding strategy

Glycan Modulation(option)

Clone selection

50L Model

Establishment

Confirmation (CQA)

Testing run (KPP)

• Excipients and conditions screening: to define a formulation development strategy (Buffer system, pH, stabilizer, tonicity modifier etc.)

• Physiochemical characterization• Developing stability-indicating analytical method• Accelerated studies

Bench Scale

Pilot Scale

Commercial Scale

Downstream Process Development - Bench scale/ Pilot scale/ Commercial scale- Cost, CQA, Stability, Recovery

11

Material for Downstream

Capture Purification

Intermediate Purification

Polishing

Virus Clearance

FormulationDrug

Substance

Formulation Development

• Column scale (ID)= 5 ~ 50 mm

• Column scale (ID)= 26 ~ 140 mm

• Column scale (ID)= 70~ 630 mm

Confidential2016MAR

Fill/FinishingService

Aseptic Filtration and Filling• Material of filter membrane selection• Liquid Filling: Max. Batch Size = 1500~5000 vials (2R~20R) • Lyophilization Filling: Max. Batch Size = 3200 vials (2R)• Pre-filled Syringe : Max. Batch Size = 4000 syringes

Labeling and Packaging• Product labeling• Product re-labeling• Clinical Trial Material (CTM) assembly/packaging/labeling


Drug Product Production- Aseptic Fill/Finishing


• Cell based bioactivity assay– Proliferation– CDC– cAMP– Cytotoxicity

• Neutralization assay• Binding assay

Protein Analysis and Characterization

• LC-MS for Full sequence, N-terminal sequence, C-terminal sequence, PTM, glycosylation site, glycan structure, and Disulfide linkage,

• Secondary structure by CD and FT-IR

• NMR or X-ray crystallography for higher order structures

• Identity by SDS-PAGE• Charge variants by IEF, cIEF, CZE• Size variants by SDS-PAGE, • Immunochemical properties by WB, • Carbohydrate by monosaccharides analysis and

glycan analysis, • Amino acid composition analysis

• Sterility• Bioburden• Endotoxin • pH • Conductivity• Liquid Particulate matter• TOC• Removable volume • Uniformity-WV• Water content • Osmolality• HPLC

– Size exclusion– Reverse phase– Ion exchange– Hydrophobic interaction

• CE-SDS• Process related impurity

– Host cell protein– Host DNA– Triton X-100– Imidazole– Insulin– Protein A residue– Heparin residues

• Peptide mapping • SDS-PAGE• Western Blot• IEF/ cIEF

• UV absorbance• ELISA• BCA/ Bradford/ Lowry

assay• HPLC

– Affinity – Reverse phase

• Formulation content– Detergent– Preservative

Physicochemical and Immunological Properties

Purity and Impurities

Content Potency/ Bioassay Identity

PharmacopeiaStructural Characterization


Production Process / Analytical Method Development Mycenax generic platform for monoclonal antibody drugs Upstream process development

Mammalian cell culture Process development: 5 L stir tank and ambr system Scale-up and GMP production: 50/200/500/2000 L

single use bioreactor Microbial fermentation

Process development: 7.5 L stir tank Scale-up and GMP production: 50 L single use

bioreactor Downstream process development

Purification process research Formulation research

Analytical method development/qualification/validation Characterization and comparability study

PIC/S GMP manufacturing Master / Working cell banking GMP manufacturing Aseptic fill/finishing

Liquid in vial Liquid in prefilled syringe (PFS) Lyophilization in vial

CTD package (Module 3- CMC) IND/NDA submission

Biosimilar Pipeline


Applying Mycenax Expertise to Biological Drug Development

Project OriginatorCell

clonePre-IND Phase I Phase II Phase III Market

TuNEX®Etanercept-similar

Enbrel®

LusiNEXTocilizumab-similar

Actemra®

*Adalimumab-similar Humira®

Omalizumab-similar Xolair®

AiNEXBevacizumab-similar

Avastin®

*Trastuzumab-similar Herceptin®

*Cetuximab-similar Erbitux®

GranNEXFilgrastim-similar

Neupogen®

Au

toim

mu

ne

On

colo

gy

Launchin 2017

IND filingin 2017

* : Cooperate with TPG Biologics, Inc.

2016MAR

Pipelines

Confidential16

Summary


What Mycenax Can Do forYou


• Mycenax focused on developing quality and cost competitive platforms for biological drug development

• A total solution for protein drug development by using disposable technology in PIC/S GMP certified facility.

• Disposable technology with up to 2000L scale.

As a CDMO Provider

• Aggressively evaluating Bionovels.

• Mycenax partners with biopharmaceuticals, especially for BIO CMC development and M&S.

As a Biosimilar Partner and Bionovel Codeveloper

Satisfy Your Needs

From Bench to Better Lives


mycenax introduction_

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