Manufacturing
Manufacturing of Cell Culture Media

Zencore Biologics is able to provide manufacturing service of customized culture media and highly universal CHO platform Fed-batch & Perfusion commercialized culture media for our customers. Meanwhile, we are able to provide OEM service as well.

Zencore Biologics has GMP-grade media-dry powder production line with up to 200 tons per year capacity. Our production scale is from 1kg to 1,200kg, and are able to support from preclinical to commercial stage. We have produced over 40 tons customized culture media for the usage of Phase III and commercial stage for our customers.

Welcome to email us for consultation, application and trial, and contact us at BD@zgbiotech.com.

Zencore Biologics Media Manufacturing will provide you
  • Formulation Development

  • Commissioned Production

  • Customized Formulation Development

  • Batch Consistency

    Study

  • Customized Production of Serum-free Media

Competitive Advantages
  • Suitable for use in the manufacturing large-scale CHO cell culture 

  • Consistency between production lots

  • Excellent stability of culture media formulations

  • Contains no animal derived components and adheres to local and international regulatory guidelines, expediting the marketing applications

  • Zencore Biologics customized media helps you lower production costs during scale up

  • Our RA team at Zencore Biologics will provide submission support for EMA, FDA and NMPA filings

  • Raw material suppliers are audited and managed under Zencore Biologics quality system 

  • Internationally accepted grinding system 

  • Perfect culture media quality testing and evaluation system 

  • Production scale ranging from pilot to GMP production

Entrusted production process
Stability study
Quality Control
Process development and production
Evaluate client needs
Stability study
  • Storage stability study  

  • Transportation stability study  

  • Room temperature stability study


Quality Control
  • Routine testing items: appearance, pH, osmolarity, loss on drying, endotoxin, microbiological purity, cell growth (72 h) 

  • Customizable testing items: cell growth (continuous culture based on customer's production process), protein expression, SEC, CEX, glycoform analysis, amino acid analysis, trace element detection  

Process development and production
  • Small-scale production (5-30 kg)  

  • Pilot-scale production (30-300 kg) 

  • GMP production (0.3-1 t)


Evaluate client needs

Evaluate client needs during initial tech transfer. Based on the requirement, our media team can either manufacture an existing media formula or a custom-made media formulation.

Contact
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