Bioprocess Development & Manufacturing, Built for Scale.

From a single vial of DNA to GMP drug product, ChemPartner’s integrated Biologics CDMO delivers cell line development, formulation, analytics, and fill/finish under one quality system, anchored by a purpose-built 45,000 m² manufacturing campus.

One Quality System. Every Stage of the Molecule

Biologics programs lose time at every vendor handoff. ChemPartner runs cell line through commercial supply in a single, connected CDMO — so process knowledge, analytics, and regulatory documentation travel with your molecule instead of restarting at each stage.

Cell Line & Banking

Process & Formulation

Analytical & Characterization

Scale-up & Tech Transfer

GMP DS/DP & Fill/Finish

★

IND / BLA &  Commercial Supply

A campus engineered for single-use scale.

A dedicated biologics campus engineered for flexible, single-use manufacturing — from early clinical batches to commercial-scale supply.

9 × 2000L

Bioreactor Suite

50L–2000L single-use fed-batch and perfusion trains on Cytiva and Thermo Fisher platforms.

45,000 m²

Campus

Purpose-built biologics CDMO site at Lingang, Shanghai, with GMP Drug Substance and Drug Product suites.

2 lines

Fill / Finish

Bosch and IMA (ORABS) aseptic filling for liquid injection, plus an IMA lyophilizer.

575+

Scientists

Biologics R&D, CMC, and CDMO specialists across discovery-to-commercial platforms.

Ten capabilities, one integrated platform.

Each module maps 1:1 to a Bioprocess sub-section — run them end to end from DNA to BLA, or plug in the single stage your program needs.

Every biologic starts with the clone. We generate and select high-expressing, stable cell lines engineered for titer, product quality, and manufacturability — with imaging-verified monoclonality and full cell-bank life-cycle management.

Documented monoclonality and stability data packages built to withstand IND and BLA scrutiny.

HIGH-THROUGHPUT CLD

VIPS single-cell seeding with whole-well imaging for monoclonality assurance
Cell Metric daily clonal outgrowth imaging
Octet-based titer and product-quality screening
Host lines for mAbs, BsAbs, fusion proteins & ADC intermediates

CELL BANKING

PCB / MCB / WCB establishment and internal release
Cell-bank transfer, resuscitation, and off-site backup storage
QC monitoring under an intelligent management system

Upstream and downstream development on a Quality-by-Design foundation — from media and feed optimization through platform purification and impurity clearance, built to scale and transfer cleanly.

CPP identification and QbD design space defined for consistent, scalable, transferable processes.

UPSTREAM (USP)

DOE/HTS media & feed screening in tube, flask, and bioreactor formats
20mL–250L fed-batch process development
ATF-based perfusion intensified culture (ATF2/4/6)
Bioreactor optimization: temperature, pH, agitation, gas flow

DOWNSTREAM (DSP)

Protein A capture with IEX / mixed-mode polishing
Viral inactivation, nanofiltration, UF/DF
ÄKTA Pilot and Avant systems with HT resin screening
DoE-driven flexibility for hard-to-purify molecules

Stability-driven formulation from developability assessment to high-concentration and lyophilized presentations — de-risking the molecule before GMP investment.

In-silico plus wet-lab developability triage flags stability liabilities before GMP spend.

SCREENING & ASSESSMENT

In-silico and wet-lab developability triage
pH, buffer, surfactant, and protectant screening
Pre-formulation and forced-degradation studies

PRESENTATIONS

High-concentration platform for subcutaneous delivery
Freeze-thaw, Drug Substance mixing, and comparability studies
Lyophilization cycle development integrated with Drug Product

Method development, qualification, transfer, and validation — backed by full structural and biophysical characterization for release and stability testing.

Phase-appropriate, ICH-aligned methods that travel with the process into GMP QC.

METHODS & CHARACTERIZATION

Purity & identity: SEC-HPLC, CE-SDS
Charge variants: iCIEF / CEX
Peptide mapping: LC-MS sequence coverage & PTMs
Higher-order structure: CD, DSC, DLS
Potency: ELISA, cell-based assays; SPR/BLI affinity
Residuals: HCP, HCD, Protein A
One-stop release and stability testing

Engineering-based scale-up that holds critical quality attributes constant from bench to GMP — with two routing options matched to your milestone.

Two-track routing gets early material fast, then carries a locked process into tox and clinical with no re-learning curve.

NON-GLP / EARLY ROUTE

Rapid, cost-efficient research-grade Drug Substance for early PK and biology
Stable-pool and early-clone material for screening
Quick-turn analytics to de-risk before GMP spend

FOR TOX & CLINICAL

Locked, characterized process for GLP tox and clinical supply
Process characterization, comparability, and validation
kLa and P·V-based scale correlation for robustness
200L–2,000L GMP scale-up with full documentation

Clinical-to-commercial drug substance and drug product manufacturing under an ICH, NMPA, FDA, and EMA-compliant quality system.

100% success rate across 40+ NMPA & FDA IND filings supported to date.

PRODUCTION

200–250L, 500L, and 2,000L GMP Drug Substance production
Drug Substance and Drug Product release testing and disposition
Process validation, PPQ, and continuous process improvement

REGULATORY

Bilingual IND / BLA dossier authorship
Post-IND and post-BLA amendment support
Comparability and stability program management

Broad modality coverage on single-use trains — from standard antibodies to complex multi-specific and conjugate formats.

mAb, BsAb, fusion protein, and ADC programs all run through the same integrated platform.

MODALITIES

Monoclonal antibodies, bispecific and multi-specific antibodies
Fc-fusion proteins and recombinant proteins
ADC drug-substance and intermediate

PLATFORM

Cytiva & Thermo Fisher single-use bioreactor platforms
Fed-batch and perfusion culture technologies
ÄKTA and Millipore purification systems

GMP sterile fill/finish of liquid injectables on isolator-protected lines with integrated in-process controls.

Restricted-access barrier (ORABS) design safeguards sterility for clinical and commercial fills.

LINES & CONTROLS

Bosch and IMA ORABS aseptic filling lines
Vial filling for liquid and pre-lyophilization presentations
Media fills and container-closure integrity testing
In-line inspection and full batch documentation

Cycle development through GMP lyophilized drug product — engineered for stability, elegant cake morphology, and efficient, scalable runs.

Water-injection and freeze-drying lines are co-located for seamless liquid-to-lyo transitions.

DEVELOPMENT TO GMP

Lyophilization cycle development (freezing, primary & secondary drying)
Pilot-scale through commercial IMA lyophilizers
Cake appearance, residual moisture, and reconstitution control
Robust cycles transferred with the Drug Product process

Risk-based extractables and leachables strategy across single-use process trains and container-closure systems — with trace-level analytical read-outs.

E&L data is built into the CMC package to de-risk regulatory review of single-use processes.

STRATEGY & ANALYTICS

Materials selection and risk assessment for packaging and auxiliaries
Extractables screening on single-use assemblies and container-closure systems
Leachables studies aligned to product stability timelines
Trace quantitation by GC-MS, LC-MS, and ICP-MS

Not sure which stage your program needs?

Map your molecule to the right entry point — from a single vial of DNA to commercial supply — with a ChemPartner CDMO scientist. One quality system, one team, from first call to BLA.

A track record that de-risks your next filing.

CMC PROJECTS COMPLETED

200+

DS / DP GMP BATCHES MANUFACTURED

400+

CELL LINE DEVELOPMENT PROJECTS

100+

NMPA & FDA IND FILINGS

40+

Discovery-Rooted. Manufacturing-Proven.

Integrated CDMO, one quality system

Cell line, process, formulation, analytics, and GMP manufacturing share one quality and data system. Characterization findings feed the next process iteration in the same campaign — no vendor-to-vendor handoffs, no lost knowledge.

Single-use, flexible capacity

A 45,000 m² Lingang campus with 9×2000 L single-use trains supports fed-batch and perfusion, plus co-located aseptic filling and lyophilization — scaling from first-in-human to commercial supply without a facility change.

Global-standard quality

The quality management system complies with ICH, NMPA, FDA, and EMA regulations, with bilingual documentation and dossier authorship supporting global submissions.

Program management

A dedicated PM and integrated joint project committee run kickoff, bi-weekly reviews, and 24/7 emergency response — keeping regulatory, quality, supply chain, and technical teams aligned on your timeline.

Frequently asked questions.

Everything a sponsor evaluating an outsourced biologics CMC partner needs to know — from capacity to compliance.

What services does ChemPartner's Biologics CDMO offer?

Cell line development, upstream and downstream process development, formulation development, analytical development, scale-up and tech transfer, GMP drug substance and drug product manufacturing, aseptic filling, lyophilization, and extractables & leachables — under one integrated DNA-to-BLA system.

What is ChemPartner's biologics manufacturing capacity?

The Lingang campus spans 45,000 m² with nine 2000 L single-use bioreactors, supporting fed-batch and perfusion from 50 L to 2000 L, plus co-located Bosch and IMA ORABS aseptic filling lines and IMA lyophilization.

Which biologic modalities can ChemPartner manufacture?

Monoclonal antibodies, bispecific and multi-specific antibodies, Fc-fusion and recombinant proteins, and ADC drug substance and intermediates.

What regulatory standards does the CDMO meet?

The quality management system complies with ICH, NMPA, FDA, and EMA regulations, with bilingual documentation and IND/BLA dossier authorship. ChemPartner has supported 40+ IND filings.

Does ChemPartner support both early-stage and clinical/commercial programs?

Yes. Scale-up and tech transfer offers a non-GLP early route for rapid material generation and a GLP/GMP-ready route for tox and clinical supply, scaling to commercial without changing facilities.

Ready to scale your biologic?

From cell line to commercial supply, ChemPartner’s integrated CDMO delivers the capacity, quality, and process continuity your program needs — under one roof, one quality system, one team.