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Manufacturing Capabilities

Integrated, agile manufacturing capacity supporting the full lifecycle of biologics, ADCs, oligonucleotides, and emerging modalities — from gene to commercial production.

Overview

Comprehensive Manufacturing Infrastructure

Our manufacturing campus is purpose-built to meet the rigorous demands of modern biologics production — from early-stage clinical batches to full commercial supply. With flexible, scalable capacity and integrated quality systems, we deliver consistent, compliant, and high-quality products at every scale.

Our capabilities support:

Core Manufacturing Workflow

From Lab to Market

A seamless seven-stage workflow that takes your molecule from early development through commercial supply.

01
Cell Line
Development
→
02
Process
Development
→
03
Pilot
Manufacturing
→
04
Clinical
Supply
→
05
Scale-up
Validation
→
06
Commercial
Manufacturing
→
07
Lifecycle
Management

Core Manufacturing Facilities

Purpose-Built Facilities for Every Stage

GMP Drug Substance Manufacturing

Phase 1–3

Flexible GMP drug substance suites for mammalian, microbial, and cell & gene therapy programs with full process validation and aseptic processing.

Capabilities

Single-use bioreactors, media/buffer preparation, harvest, purification, viral clearance, and aseptic fill-finish.

Drug Product Manufacturing

Capabilities

State-of-the-art fill lines for liquid and lyophilized vials, pre-filled syringes, and combination products with full GMP compliance.

Clinical Manufacturing

Phase 1–2

Tailored clinical supply manufacturing designed for fast turn-around and flexible batch sizes to support early-stage trials.

Key Features

Independent suites, rapid scale-down, and integrated analytical release testing.

Commercial Manufacturing

Phase 3 / BLA

Large-scale commercial production suites with full process performance qualification (PPQ) and commercial lifecycle support.

Production Scale

Scalable Manufacturing from Lab to Commercial

Our flexible capacity scales seamlessly with your program — from bench-top development to full commercial production.

Manufacturing Stage
Typical Scale
Process Development
Lab Scale
Pilot Production
50 – 200 L
Clinical Manufacturing
500 – 2,000 L
Commercial Production
2,000 – 20,000 L

Core Manufacturing Processes

Integrated Process Capabilities

End-to-end manufacturing processes engineered for quality, efficiency, and regulatory compliance.

Upstream Manufacturing

Single-use bioreactor systems with high-yield expression platforms supporting mammalian, microbial, and cell therapy modalities.

Downstream Processing

Multi-step chromatography, filtration, and viral clearance designed to maximize purity, recovery, and process robustness.

Fill-Finish

Fully automated aseptic filling lines for vials, syringes, and lyophilized products with comprehensive container closure integrity.

Quality Control

In-process and release testing, method validation, and stability studies supporting global regulatory submissions.

Technology Transfers

Robust process transfer methodology enabling seamless scale-up, site-to-site transfers, and global commercial supply.

Digital Manufacturing

Process digitalization, real-time monitoring, and data integrity controls aligned with industry 4.0 standards.

Quality Systems

GMP Manufacturing

Our global quality system is built on a foundation of regulatory excellence, operational discipline, and continuous improvement — ensuring every product meets the highest standards of safety, efficacy, and consistency.

Capabilities Include

GMP Manufacturing
Process Validation
QA/QC
Change Control
Full Documentation
Annual Stability
Process Development
Regulatory Inspections
Batch Release

Manufacturing Capacity

Scale That Grows With Your Program

A comprehensive manufacturing network with the capacity and flexibility to support programs from pre-clinical through commercial supply.

22,300 L
Drug Substance Capacity
Installed Capacity
90,500 L
Expansion Capacity
Planned Expansion
2,000–5,000 L
Commercial Bioreactors
Manufacturing Scale
200–500 L
Clinical Manufacturing
GMP Production
200 T
Media Manufacturing
Tons/Year Media Production
20 kg
Oligonucleotide API
Annual API Capacity
450K
Drug Product Filling
Vials/Year
8,000 m²
Antibody CDMO Facility
Manufacturing Facility

Quality & Flexibility

Built for Quality
and Flexibility

Our manufacturing infrastructure is designed to adapt to the evolving needs of complex therapeutic programs while maintaining the highest quality standards.

Flexible Manufacturing

Multi-modality suites that can rapidly reconfigure between programs — from small-batch clinical supply to high-volume commercial production.

Integrated Quality

Fully embedded quality systems covering GMP compliance, method validation, and global regulatory standards from development through commercial.

Regulatory Acceptance

Manufacturing operations have been successfully inspected by global regulatory agencies (FDA, EMA, NMPA) with established commercial approvals.

Why Choose Us

Why Partner With a World-Class CDMO

01

End-to-End Development

From cell line to commercial supply, our fully integrated platform accelerates timelines and reduces risk at every stage of development.

02

Flexible Manufacturing Scale

Our capacity flexes with your program — from grams of clinical material to metric tons of commercial drug substance, all within a single quality system.

03

Integrated Analytical Platform

Process and release analytics are co-located with manufacturing, enabling fast turn-around and full data integrity for your regulatory submissions.

04

Global Quality Standards

Quality systems and manufacturing operations are aligned with global GMP expectations, providing a single, trusted partner for worldwide supply.

Ready to Partner with a World-Class CDMO?

Connect with our manufacturing experts to discuss how we can support your program from development to commercial supply.

Contact Us About Our Company