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From Bench to Launch

Project Management*

Mycenax is linked with international biotech firms to form a full function or biologic production network. The main goal is to help translating the research finding to biologic products meeting the world market and regulatory needs. Mycenax specializes in biopharmaceutical process development and manufacturing to help accelerate the initiation of clinical trials and minimize expenses for the clients. Being a member of the prestige Jhunan Science-based Park in Taiwan, Mycenax is proud of its state-of-the-art facility and well-trained technical team. In the facility our technical experts conduct full cGMP operation processes utilizing most current technology complete new drug CMC activities in budget saving and timely fashion.

Mycenax is a fully integrated biopharmaceutical company that provides a wide range of development and cGMP manufacturing services. The services offered fall into four main categories:
• Product development consultation
• Process development and scale-up
• cGMP manufacturing
• cGMP aseptic filling/lyophilization

Production Process / Analytical Method Development
  • MBI’s 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: 50/200/500/2,000 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
  • Lyophilization in vial

PIC/S GMP certificate from TFDA

cGMP certificate from TFDA
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