Mycenax Biotech Inc.

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  • Cell Line Development

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  • Process Development

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  • Analytics and Quality Control

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  • GMP Manufacturing

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  • Technology Platforms

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Cell Line Development

Mycenax develops and establishes high-quality cell lines for various host cell and product types. We are the experts for all cell line development activities from vector construction to generating cell banks for GMP manufacturing in accordance with ICH and global regulatory requirements. We also support early-stage material generation for proof-of-concept studies or preclinical development programs.

Mycenax carries out cell line development as a stand-alone service or as an integrated end-to-end development solution including process development and GMP manufacturing. In addition, you can combine this service with Mycenax’ proprietary cell line development platforms to shorten the development time.

 

Host Cell Lines

  • Cell & Gene Therapy
    • Natural killer cells

Our Capabilities

  • Stable cell line generation from vector construction to cell bank generation
  • GMP master cell bank and working cell bank generation
  • Understanding of business and science-driven objectives for the choice of expression platform, e.g. IP status and licensing terms
  • Application of established, commercially proven expression platforms in order to streamline subsequent process development activities
  • Compliance with ICH and global regulatory requirements
  • Gene and codon optimization of expression plasmids
  • Clone selection based on product yield and quality, cell line stability and cell culture performance
  • Verification of critical product quality attributes by extensive analytical testing during initial steps of the clone selection process
Process Development

Mycenax uses streamlined and robust technology platforms for process development to move your projects forward fast to GMP manufacturing. Manufacturing processes are developed using quality by design principles and design of experiments approaches in accordance with ICH and global regulatory requirements. After process development, product quality is determined by state-of-the-art analytical methods and high-throughput equipment.

Mycenax offers a complete solution for process development including development of production cell lines, upstream process development, downstream process development, process scale-up, formulation development, and analytical methods.

With our experience gained over more than a decade and from various product types, our team solves all technical problems in order to ensure the success of your project.
 

Key Benefits and Capabilities

Upstream Process

Downstream Process

Formulation

Process Characterization

  • Consideration of critical product quality attributes
  • Achieve optimal process yield
  • Feasibility to scale up to GMP manufacturing
  • Economic manufacturing cost
  • Competitive cost of goods
  • Improvement of product purity
  • Removal of product-related impurities (e.g. high and low molecular weight species, variants with reduced bioactivity)
  • Removal of process-related impurities (e.g. host cell protein (HCP), host cell DNA, Protein A residue, organic solvent, detergent, additives)
  • Removal of contaminations (e.g. viruses, microorganism, endotoxin)
  • Meet critical product quality attributes
  • Achieve optimal process yield
  • Feasibility to scale up for GMP manufacturing
  • Economic manufacturing cost
  • Competitive cost of goods
  • High-quality analytical methods in place to reduce development time
  • Efficient analytical method development to establish appropriate analytical methods
  • Generation of additional data as a basis to assess deviations
  • Efficient and effective management of change control
  • Increased value of development program and data package for outlicensing partners or investors


Mycenax’ Technology Platforms

 In-house developed CHO cell medium
 Monoclonal antibody process development
 Microbial process development for recombinant proteins and plasmid DNA
 Continuous production process with improved quality and efficiency

Product Types
  • Monoclonal antibodies
  • Bi-specific antibodies
  • Antigen-binding fragments (Fab)
  • Single-chain variable fragments (ScFv)
  • Fc-fusion proteins
  • Recombinant proteins
  • Protein conjugates (non-toxin)
  • Nasal vaccines
  • Transgenic proteins
  • Peptides
  • Enzymes
  • Plasmids
  • DNA vaccines
  • Growth factors
  • Glycoproteins
  • Antibody-cell conjugate
Our Capabilities
•      Reliable technical transfer, verification, and optimization of clients’ processes
•      Development and qualification of analytical methods
•      Customized protein production
•      Process parameter investigation and process development for mammalian and microbial cell cultures
•      Development of purification processes including chromatography, tangential flow filtration (TFF), virus filtration steps

•      Formulation development

•      Fill and finish process development

•      Process scale-up to commercial scale

•      Production of GLP-grade material

•      Capability for continuous manufacturing for upstream and downstream processes

Analytics and Quality Control

Mycenax offers complete in-house analytical services for lot release testing and stability studies as well as comprehensive product characterization.
 

Product Types

  • Recombinant peptides
  • Enzymes
  • Recombinant proteins
  • PEGylated proteins
  • Monoclonal antibodies
  • Plasmid DNA
  • Oligonucleotides
  • Cell therapies
  • Antibody-drug conjugates (ADC)
GMP Manufacturing

Mycenax’ state-of-the-art biomanufacturing site is PIC/S GMP certified and located in Hsinchu Science Park (Zhunan, Taiwan). Our highly qualified and well-trained team routinely manufactures high-quality biopharmaceutical products by mammalian cell culture and microbial fermentation processes. We continuously invest in our technologies and infrastructure to ensure that we constantly meet your evolving needs of today and tomorrow.

The innovative design of our multi-product GMP facilities allows for capacity and technological flexibility while ensuring strict compliance with biopharmaceutical regulations required for GMP operations. Our dedicated and experienced technical teams are committed to delivering high-quality products in a rapid and cost-effective manner.
 

Our Capabilities

Plant

Plant 1

Plant 2

Line

Line 1

Line 2

Line 3

6 Lines

Area

1,500 m2

750 m2

750 m2

4,682 m2

Culture Type

Mammalian cell

Mammalian cell

Microbes

Commercial products

Annual Capacity

Drug substances: Monoclonal antibody substances- 7,200 g
Drug products:
400,000 vials (liquid)
140,000 vials (lyophilization)
400,000 prefilled syringes (PFS)
Drug substances: Monoclonal antibody substances- 60,000 g
50L single-use bioreactor for fermentation
Drug substances:

-Six 2000L single-use bioreactors

 

Drug products:
-4,000,000 vials
-4,000,000 syringes
 

Service

Cell bank establishment
Upstream process
Downstream process
Aseptic fill/finishing
Cell bank establishment
Upstream process
Downstream process
Cell bank establishment
Upstream process
Downstream process
Cell bank establishment
Upstream process
Downstream process
Aseptic fill/finishing

Regulatory  Target

Compliance to and implementation as per ICH, EMA, FDA, and PMDA Guidance.

Technology Platforms

Mycenax has been a pioneer in implementing cutting-edge biopharmaceutical manufacturing technologies for over a decade and has established several innovative technology platforms which enable efficient development and manufacture of high-quality biologics. Our advanced manufacturing technologies and in-house services have been tailored to offer you rapid and cost-effective solutions.
 

Technology Platform

Objective

Description

MBIFastTM

Monoclonal antibody process development

Preparation of IND enabling package from DNA to GMP manufacturing within 16 months

MBIJumpTM

One-step cell culture scale-up

Direct scale-up from 5L to final 2000L scale

MBICHOTM Medium

Easy control of cell culture to optimize product quality and maximize titer

In-house developed CHO cell medium

MBIContiTM

The continuous production process for improved product quality and process efficiency

Fully integrated production line for the single-use continuous manufacturing process

MBIMicro

Microbial process development for recombinant proteins and plasmid DNA

 

High titer Microbial platform

A stable cell clone with high-level production