Services & Capabilities

Commercial Drug Product (DP) Manufacturing

WuXi Biologics, as a leading Contract Research, Development and Manufacturing Organization (CRDMO), operates multiple state-of-the-art, world-class drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biotherapeutics, vaccines, placebo and parenterals filled into either liquid or lyophilized (if applicable) dosage forms. We perform drug product fills into a variety of container and closure system (CCS) configurations that include vials, prefilled syringes and other combination product CCS.

All of our facilities provide isolator-based, fully-automated final drug product formulation and filling under Current Good Manufacturing Practice (cGMP) conditions as defined by the worldwide regulatory agencies, including the United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and National Medical Products Association (NMPA). We have provided cGMP drug product for late-stage clinical and commercial use into a variety of countries and regions such as the US, EU, China, Japan, South Korea, Singapore, Australia, Israel and India.

The success of our GMP drug product operations is also due in part to our concept to commercialization drug development platform, extensive GMP drug substance manufacturing network, outstanding quality system and excellence in project execution (see “The WuXi Biologics Difference” short videos for more information). For details on each DP facility, click the corresponding links below.

DP1 – High-Performance Drug Product Manufacturing

Based in Wuxi, China, our DP1 facility provides aseptic drug product manufacturing for clinical and commercial biologics, supporting both liquid and lyophilized products with annual capacity of up to 6 million doses.

Since GMP release in 2014, DP1 has delivered over 1,100 batches with a success rate exceeding 99%. This success includes multiple process performance qualification (PPQ) and commercial batches, all meeting FDA, EMA, and NMPA regulatory standards. Backed by over 170 customer and agency audits, DP1 ensures uncompromising safety and efficacy in every batch.

Site Specifics

DP1 features a washing machine, sterilization and depyrogenation tunnel, filling, stoppering, weight check, automatic in-process control, capping, and a restricted access barrier system—all state-of-the-art.
The production line includes automatic freeze-drying equipment with online clean-in-place and sterilization-in-place processes, along with automated feeding and discharging.
Multiple filling specifications are supported, including 2R, 6R, 8R, 10R, 14R, 20R, and 50R.
A variety of mixing system specifications accommodate different client requirements and batch types.
DP1 is equipped with 100% manual visual inspection, labeling, and packaging functions.
All product-contact materials are 100% disposable. A sterile filtration process with pre-use post-sterilization integrity testing (PUPSIT) enhances contamination control.
Comprehensive environmental monitoring occurs throughout the entire filling process to maintain compliance and product integrity.

DP2 – Industry-Leading Vial Filling

DP2 provides end-to-end services for sterile drug products, covering process optimization, scale-up, and commercial manufacturing for liquid and lyophilized formulations. With technology transfer times as fast as 3 months, DP2 accelerates product launches in the U.S. and Europe and China. Having served over 35 global clients, including top pharmaceutical companies, DP2 operates under a quality system compliant with FDA, EMA, and NMPA regulations, with successful EMA, FDA, and NMPA audits.

DP2 features an IMA isolator filling line and two 20 m² lyophilizers, meeting all requirements for sterile product manufacturing from clinical phases I, II, and III through commercialization. Filling volumes range from 0.1 to 50 mL, while batch volumes span from 1 to 1,000 L, with batch sizes of up to 250,000 units each. DP2 has an annual capacity of up to 10 million vials and can accommodate 24 million vials of a single size.

A 100% weighing system ensures high-precision filling with optimal yield. Additional design features allow specialized handling:

A light-yellow background and controlled lighting protect photosensitive products.
Filling and lyophilization processes support nitrogen filling, protecting oxygen-sensitive products.
A laser-based headspace residual oxygen leak detector enables non‑destructive oxygen content analysis.

Within three years of release, DP2 has completed nine process performance qualification (PPQ) projects. To date, the facility has produced over 200 batches with a 100% success rate.

Site Specifics

A 100% online fill weight check fills until empty.
A parts washer reliably keeps tools and parts clean.
A PUPSIT-based filter system meets European Annex 1 Regulation requirements.
Multiple filling specifications are supported, including 2R, 6R, 8R, 10R, 20R, and 50R vials.

DP5 – Committed to Prefilled Syringe Quality

Our DP5 manufacturing facility in Wuxi, China, features an isolator filling line dedicated to sterile prefilled syringe (PFS) production. To meet diverse client requirements, DP5 offers manual, semi-automatic, and fully automatic visual inspections. Since achieving GMP release in 2022, DP5 passed the FDA’s Pre-License Inspection (PLI) in 2024, reinforcing our commitment to regulatory excellence.

As a drug-device combination product, a PFS provides precise dosing, improved drug availability, and safer, more efficient administration—making it an increasingly preferred dosage form.

Site Specifics

Inline weight check
Liquid fills:
- Fill volume range of 0.1 to 3.5 mL
- Maximum filling speed of 400 PFS per minute
- Maximum annual capacity of 17–20 million PFS units
Syringe sizes 1 mL standard, 1 mL long, 2.25 mL, and 3 mL standard sourced from multiple vendors
Single-use disposable materials preventing cross-contamination
Nitrogen blanketing for oxygen-sensitive products
Yellow-light filling for light-sensitive products
Automatic disinfection machine that brings primary packaging into an aseptic filling environment

Available for GMP Production Since 2020

DP7 is a commercial-scale Drug Product (DP) aseptic filling and freeze-drying plant acquired from Bayer in April 2020. This 13,000 m² world-class facility provides entire DP manufacturing services using a flexible isolator-based and state-of-the-art Optima filling system. The system includes automated loading/unloading, isolator decontamination, vial washing, depyrogenation, sterile filling, stoppering, capping, lyophilization, automatic visual inspection and tray loading.

In 2025, an additional line will be installed to enable the filling of prefilled syringes (PFS).

Site Details

State-of-the-art technology applied to assure product sterility, including isolators, disposable and stainless-steel (SS) systems with CIP/SIP
Facility is adaptable to single-use (SU) processes
Fully automated control system for facility and process equipment
Physically separated areas for bulking, filling and component prep
Integrated online, in-process control solutions to reduce aseptic interventions and process variations
Isolator (Grade A) in clean room (Grade C) environment
Liquid filling independent of freeze-drying (lyophilization) process
Automated lyophilization loading and unloading

Capacity and Capabilities

Aseptic process-based liquid and lyophilized drug product manufacturing
Vial sizes available: 2R, 6R, 8R, 10R, 20R, 50R
High-throughput filling (170 vials/min) with an annual capacity of 5~10M vials
Lyophilization capacity (2 x 23 m² freeze dryers)

Expansion of facility

Additional line planned for prefilled syringes (PFS)
GMP readiness of PFS line planned for end of 2025
Expected annual capacity of around 10M PFS
PFS formats from 0.5ml to 3ml
Aseptic process-based liquid and lyophilized drug product manufacturing

DPPC – Strategic Support for Drug Product Manufacturing

Our drug product packaging center (DPPC) supports drug product packaging and labeling at clinical and commercial scales. Clients can customize these end to-end services to meet market demands and regulatory requirements. DPPC also provides a wide range of secondary and tertiary packaging solutions.

Conveniently located near multiple drug product manufacturing facilities in Wuxi, China, DPPC houses three commercial-scale packaging lines. WuXi Biologics’ global GMP experts operate an anti-forgery drug tracking system and automatic labeling machine to enhance security and efficiency.

DPPC complies with Current Good Manufacturing Practices (cGMP) for the U.S., Europe, and China. Since achieving GMP release in 2020, the center has passed multiple EMA and NMPA inspections.

Site Specifics

Clinical- and commercial-scale packaging
Serialization with aggregation levels 2, 3, and 4
Customized art design
Blinding labeling, booklet labeling, color film, and more
Ink or UV coding
PFS assembly and packaging (plunger rod with backstop and needle safety device)

This liquid and lyophlization dosage form drug product fill facility is part of a 10-year USD$1.4 billion (S$2 billion) investment to establish a cutting-edge, fully integrated CRDMO center in Singapore. The investment strengthens WuXi Biologics’ global research, development and manufacturing network to meet the growing demand from clients worldwide for end-to-end services, and continues to enable its Global Dual Sourcing strategy.

Site Details

Clinical- and commercial-scale fills for vials and prefilled syringes (PFS)
Vials: Up to 10 million doses/year
PFS: Up to 17 million doses/year
2 x 20 m² lyophilization systems

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