Services & Capabilities

Late Stage Development and Process Characterization

For companies looking to bring biologics and vaccines to the market, WuXi Biologics provides late-stage development and manufacturing services. Our technology platforms deliver an integrated solution that streamlines assay and formulation development, optimization, characterization, and validation to prepare your program for BLA filing in 15 months or less. When you are ready to progress beyond BLA, we activate our drug substance (DS) and drug product (DP) network. This expansive system furnishes GMP manufacturing and supplies commercialized products at a global scale.

Whether through mammalian cell culture, microbial fermentation, or in vitro methodologies, WuXi Biologics ensures the highest quality in product development. Our expert teams are dedicated to helping you meet critical BLA filing milestones, no matter your scenario.

Late-stage commercial process development (CPD) covers the critical juncture between IND filing and commercial manufacturing readiness. CPD activities focus on scalability, productivity, manufacturing cost of goods sold (COGS), and process robustness to enhance product quality and gather critical process knowledge before process characterization (PC) and process performance qualification (PPQ) runs.

Keys to late-stage success

Compared to a traditional fed-batch biomanufacturing process at the same scale, our advanced fed-batch and continuous bioprocessing technology enhance efficiency and productivity. These advancements reduce production time and increase yields while maintaining high product quality and consistency. Improvements to upstream and downstream performance and the consumption of raw materials—such as buffers, membranes, filters—reduce manufacturing costs.

Productive cell culture*:
- A 3–9-fold increase in DS productivity
- A fed-batch titer of ≤ 35 g/L in a 14-day culture period
Reduced COGS*:
- Downstream process yield improvements of 10–15%
- Manufacturing cost reduction of 60–80%
Minimal environmental impact:
- Environmental, social, and governance (ESG) principles built into the process design
- Raw material reduction of 20–60% for decreased waste generation
- Doubled purification throughput
Rapid timelines and more:
- Late-stage process development and optimization in 3–5 months
- DS PC in 4–8 months
- Comprehensive analytical development for in-depth product characterization
- Annual capacity for > 40 late-stage projects

*Compared to traditional fed-batch at same scale

Upstream and downstream technology gains

Data-based quality monitoring and method development

HPLC-based assays:

Titer
SEC-HPLC
CEX-HPLC
RP-HPLC
HIC-HPLC
PS-20/80
Sialic acid assay
N-glycan profiling
Peptide mapping
Research material generation
Target evaluation and identification
MAb discovery (antibody generation and screening)
- Hybridoma
- Phage display
- VHH library
- Single B cell cloning
Developability assessment
Lead optimization
In vitro characterization
In Vivo characterization

CE-based assays:

CE-SDS(Reduced and Non-Reduced)
iCIEF

Intact, reduced, and deglycosylated mass analysis
Peptide mapping
Disulfide bond analysis
Sequence variants analysis

All types of ELISA
Affinity by BLl: concentration determination, affinity determination, and kinetics
Enzyme activity and enzyme-specific activity determination
Homogenous cell-binding
Anti-proliferation and neutralization
Cellular signal transduction, apoptosis, and killing
Antibody functional analysis: ADCC (PBMCs, NK cells, or reporter-gene cell line), ADCP, and CDC

Appearance, color, clarity, pH, and osmolality
Extractable volume
Moisture content
Visible particles
Sub-visible particles

Residual HCP
Residual DNA
Residual Protein A
Protein concentration (UV)
Western blot
SDS-PAGE (NR and R)

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PC prepares for process validation, product license application, and commercialization. As an essential milestone in a product’s lifecycle, PC benefits from a systematic, standardized strategy aligned to a quality by design (QbD) approach.

Standardized strategies

To define key process parameters, we first prepare a failure mode effects analysis (FMEA) and identify presumptive critical quality attributes (CQAs) that impact product potency, safety, and quality. Using design of experiment (DoE) and one-factor-at-a-time (OFAT) methods, we then characterize each process step with qualified scaled-down models. A final FMEA confirms CQAs, refines the process, and defines the control strategy to ensure process readiness for process performance qualification (PPQ).

Expediting the timeline

Our highly efficient 4–8-month PC timeline accelerates your path to market application. The typical timeline is 12 months.

Comprehensive deliverables

Our comprehensive list of PC deliverables aligns execution and stages proper management of data and knowledge.

PC master plan
CQA list
Risk assessment reports
Model qualification reports
Method qualification reports

PC protocols of unit operations
PC reports of unit operations
PC summary reports
Process and analytical control strategy

Beyond the critical late-stage process development and characterization activities, conducting BLA-enabling studies ensures a thorough understanding of process and product before submission. WuXi Biologics has established specialized teams and capabilities to execute these studies, which include viral clearance (VC) validation, resin and membrane lifetime, product characterization and comparability, and in-depth characterization of process-related impurities—particularly host cell proteins (HCPs).

Resin and membrane lifetime

A resin and membrane lifetime study at lab scale serves dual purposes: establish the number of cycled resins or membranes that can be used in large-scale manufacturing and generate used resins for BLA-enabling VC studies.

Critical study components:

Scale-down model design
Feed material generation
Experiment design and criteria for cycle-stop across each unit operation
In-process analytical support
Logistical support
Data analysis via a database encompassing more than 50 common resins and membranes like protein A affinity, immobilized metal affinity, ion exchange, hydrophobic, and mix mode

Viral clearance validation

WuXi Biologics provides downstream purification process consultation, scale-down models, material generation, and integrated chromatography media lifetime studies. Our highly customizable BLA-enabling VC validation programs adhere to ICH Q5A guidelines. After conducting over 120 BLA VC studies, we are considered an industry leader in bioprocess VC and inactivation unit-step evaluations. Our extensive experience also covers VC evaluation in continuous production and other advanced manufacturing processes.

Over 10 BLA VC studies per month
In-house VC database with > 12,000 log reduction value (LRV) data points
High-purity, high-quality model viruses and established indicator cell lines
Fully remote service that frees you from onsite execution

Product characterization and comparability

Product characterization requires a comprehensive understanding of the characteristics of biologics to ensure product safety and efficacy. Accordingly, WuXi Biologics offers advanced solutions for product characterization, CQA identification, and identifying an analytical control strategy.

Extensive experience
- BLA enabling product characterization for 40+ projects
Accelerated timeline
- Size and charge variant characterization in < 2 months
- Comprehensive forced degradation study in < 3 months
Leading capabilities
- Size and charge variant fractionation at milligram levels
- Structure characterization with advanced instrumentation
- Bio-functional characterization with binding and cell-based assays

Process-related impurity assessment and control

Process-related impurities and residuals are produced and introduced throughout bioprocessing, including the cell culture-derived and downstream purification-associated impurities. Based on specification setting to ensure quality and consistency (ICH Q6B) and patient safety considerations, impurities and residuals should be assessed and corresponding criteria should be met. A complete panel of highly specific and sensitive analytical methods deliver reliable qualification and quantification results to support acceptance criteria for impurity control and product safety assurance.

Integrated HCP analytical services

WuXi Biologics leverages onsite laboratories, an onsite HCP database, and specialized knowledge to offer an integrated suite of residual HCP detection solutions that empower your program’s success. Our service portfolio encompasses HCP method development, coverage analysis, and thorough HCP risk assessment to identify and quantify HCP impurities at the highest standards. Our deployment targeted and untargeted HCP (liquid chromatography-mass spectrometry [LC-MS]) analysis to deliver accurate, reliable results.

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