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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 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

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

Highly consistent with the reference drugSuperior Quality

  • Product quality is highly consistent with the reference drug
  • While developing a fusion protein-expressing cell line for a client, Zencore applied screening and continuous optimization of in-house developed media.
  • Upstream cell culture processes and downstream purification processes are closely 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 robust processes: reproducible, scalable processes with ideal product quality and high expression levels. 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 adjusting medium composition, culture temperature, pH and harvest time and other parameters, Zencore tunes glycosylation to the desired level and optimizes the proportions of charge isomers, aggregates, fragments and glycation.
What We Offer

Upstream process development: what we can provideService 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 standard.

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

Through a customized manufacturing process, Zencore delivered a product with a glycan profile highly consistent with the reference standard, meeting 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, requiring strict control of fragment levels at the cell culture stage.

Zencore's actions

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

Results

By combining media formulation development with cell culture process parameter optimization, Zencore reduced fragment content by 50%, meeting quality control requirements while improving titer.

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

Main equipmentKey Equipment

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

Sartorius benchtop bioreactors

Sartorius benchtop bioreactors

68+ units in total, forming the primary platform for 2–20 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