生物工艺开发与生产，专为规模化打造。

从一管 DNA 到 GMP 成品制剂，睿智医药（ChemPartner）一体化的生物药 CDMO 在统一的质量体系下，提供细胞株开发、制剂开发、分析检测以及灌装/成品制剂服务，并以一座专为生物药生产打造的45,000平方米生产基地为坚实依托。

统一质量体系，覆盖分子全生命周期。

生物药项目在每一次供应商交接时都会损失时间。睿智医药（ChemPartner）通过单一且贯通的 CDMO 体系，提供从细胞株到商业化供应的全流程服务——从而使工艺知识、分析数据和法规文件能够随着您的分子一路传递，无需在每个阶段推倒重来。

细胞株与建库

工艺与制剂

分析与表征

放大与技术转移

GMP 原液/制剂与灌装

IND / BLA 与商业化供应

为一次性规模化工艺而打造的园区

一座专为灵活的一次性生产而设计的专属生物药园区——覆盖从早期临床批次到商业化规模供应的全流程。

9 × 2000L

生物反应器车间

基于 Cytiva 和 Thermo Fisher 平台的 50L–2000L 一次性补料分批与灌流生产线。

45,000 m²

园区

位于上海临港的专为生物药 CDMO 打造的基地，配备符合 GMP 标准的原液（DS）与制剂（DP）生产车间。

2 条产线

灌装线

采用 Bosch 和 IMA（ORABS）进行注射剂无菌灌装，并配备 IMA 冻干机。

575+

科研人员

涵盖从药物发现到商业化平台的生物药研发、CMC 及 CDMO 专家。

十项能力，一个一体化平台

每个模块与生物工艺的子环节一一对应——您可以从 DNA 到 BLA 全流程端到端运行，也可按项目需求单独接入特定阶段。

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.

PROOF POINT

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.

PROOF POINT

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.

PROOF POINT

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.

PROOF POINT

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.

PROOF POINT

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.

PROOF POINT

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.

PROOF POINT

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.

PROOF POINT

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.

PROOF POINT

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.