Cell Line Development
Process Development
Analytics and Quality Control
GMP Manufacturing
Technology Platforms
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
- Mammalian Cell Lines
- CHO
- SP2/0
- HEK
- Microbial Cell Lines
- E. coli
- 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
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
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Mycenax’ Technology Platforms
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
• 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
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)
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. | |||
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 |
| Monoclonal antibody process development | Preparation of IND enabling package from DNA to GMP manufacturing within 16 months | |
| One-step cell culture scale-up | Direct scale-up from 5L to final 2000L scale | |
| Easy control of cell culture to optimize product quality and maximize titer | In-house developed CHO cell medium | |
| The continuous production process for improved product quality and process efficiency | Fully integrated production line for the single-use continuous manufacturing process | |
| Microbial process development for recombinant proteins and plasmid DNA |
High titer Microbial platform | A stable cell clone with high-level production |