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UPSTREAM PROCESS DEVELOPMENT

Upstream Process DevelopmentUpstream Process Development

Drawing on an internationally advanced cell culture research laboratory and a professional technical service team, Zencore has built an outstanding upstream process development platform. Focused on developing stable, high-yielding, easily scalable products and scalable processes, it is one of Zencore's core technologies.

Multiple rounds of process development in 8-10 weeks2 L · 5 L · 20 L bioreactorsRobust scale-up to 2,000 LQbD principles applied throughoutGlycosylation control
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8-10 weeks
Multiple rounds of process development from 250 mL (shake flask) to 20 L (bioreactor)
2,000L
Robust scale-up capability (200 L / 500 L / 2,000 L)
-50%
Case study: reduced antibody fragment content after process optimization
+29%
Case study: titer improved from 3.5 to 4.5 g/L after optimization
Platform Features

Platform featuresFast · High quality · Strong processes

Guided by a service philosophy of relentless pursuit and pioneering innovation, we deliver creative and effective solutions, ensure product quality and maximize efficiency.

Fast

Rapid development · rapid scale-upFast Development

  • 8-10 weeksmultiple rounds of process development from 250 mL (shake flask scale) to 20 L (bioreactor scale) are completed within
  • in-house CHO-K1 cell culture platform process, combined with in-house chemically defined media and high-quality cell lines, rapidly 2L、5L、20L Bioreactor-scale process lock and scale-up
  • robust scale-up to 200 L, 500 L and 2,000 L
  • The expert technical team commands high-quality, high-efficiencyTechnology transfer workflow, helping clients save valuable R&D time
High quality

highly consistent with the reference drugSuperior Quality

  • Product quality andhighly consistent with the reference drug
  • While developing a fusion protein-expressing cell line for a client, through screening and continuous optimization of in-house developed media,
  • Upstream cell culture processes and downstream purification processesclosely integrated, ultimately developing for the client a cell line whose product quality closely matches the reference drug
Strong processes

Practicing QbD · risk controlRobust Processes

  • Pursuing reproducible, scalable processes with ideal product quality and high expression levelsRobust processes; QbD principles and practice are applied throughout the entire project development process
  • Continuous risk assessment clarifies optimization direction and reduces project risk:Media screening and optimization, process parameter studies, CPP/KPP identification, control strategy definition and process lock
  • By adjustingmedium composition, culture temperature, pH and harvest timeand other parameters, adjusting glycosylation to the desired level and optimizing the proportions of charge isomers, aggregates, fragments and glycation.
What We Offer

Upstream process development can provide you withService Scope

01Clone screening
02Custom media screening
03Critical process parameter studies
04Process parameter studies to improve titer
05Process parameter studies for quality control
06Perfusion process development
07Process transfer and scale-up
Zencore Biologics upstream process development laboratory
Workflow

Development workflowDevelopment Workflow

Starting with shake-flask DoE and progressively validating in bioreactors, locking the process in four steps.

Upstream process development workflow: media screening (shake flask) - process parameter DoE studies (shake flask) - process parameter studies (2 L-5 L bioreactor) - process scale-up and confirmation (20 L bioreactor)
Shake flask - small bioreactor - scale-up confirmation, a progressively scaled, data-driven development pathway
Media screeningShake flask scale
Process parameter DoE studiesShake flask scale
Process parameter studies2 L-5 L bioreactors
Process scale-up and confirmation20 L bioreactor
Case Studies

Case StudiesSuccess Stories

Two representative projects in which cell culture processes solved real quality challenges.

CASE 01

modulating antibody glycan profiles

Challenge overview

the G0F content was higher and galactosylation lower than in the reference product, affecting similarity to the reference product.

Zencore's actions

Based on CHO cell metabolic pathways, combined with media formulation development and adjustment capabilities, Zencore optimized the cell culture process and achieved effective antibody glycan profile modulation.

Results show

Through a customized manufacturing process,glycan profile highly consistent with the reference standardproduct that met the client's specific glycan profile requirements.

N-glycan profile analysis: bar chart comparing before/after optimization with the reference standard
N-glycan relative percentage: the optimized process (blue) converges to reference standard (cyan) levels
CASE 02

reducing the antibody fragment proportion

Challenge overview

Due to the complexity of the molecule's design and structure, fragments appeared during protein secretion and could not be effectively reduced by purification steps, requiringCell culture stagestrict control of fragment levels.

Zencore's actions

Extensive cell line screening did not effectively resolve the issue of elevated fragments; after selecting a relatively better cell line,Process development stageeffective control of fragment content.

Results show

Combining media formulation development with cell culture process parameter optimization,Fragment content reduced by 50%, meeting quality control requirements whiletiter was improved。

Fragment content, relative percent (%)
~8Before optimization ~4After optimization
▼ fragments reduced by 50%
Titer (g/L)
3.5Before optimization 4.5After optimization
▲ titer improved 29%
Key Instruments

Main equipmentKey Equipment

From benchtop bioreactors to multi-parameter biochemical analysis, covering 2 L-20 L process development and real-time monitoring.

Sartorius benchtop bioreactors

Sartorius benchtop bioreactors

68+ units in total, the primary platform for 2 L-20 L process development and parameter studies

Applikon benchtop bioreactors

Applikon benchtop bioreactors

33+ units, flexibly supporting multiple rounds of parallel process development

Nova BioProfile multi-parameter biochemical analyzer

Nova Bioprofile

Multi-parameter biochemical analysis with online monitoring of key metabolites

Roche Cedex Bio multi-parameter biochemical analyzer

Roche Cedex Bio

Multi-parameter biochemical analysis supporting data-driven decisions in culture processes

ABL9 blood gas analyzer

ABL9 blood gas analyzer

Rapid blood gas analysis for real-time control of culture environment parameters

Stable, high-yield, easily scalable upstream processes

From shake flask to 2,000 L, Zencore's upstream process development platform helps your project lock in the process and scale up robustly.

Inquire about upstream process development