Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

Our downstream process development program will optimize yields, improve product purity and provide a robust, reproducible and scalable purification process by using technologies and raw materials suitable for cost-effective large-scale manufacturing. Services include:

  • High throughput process development (HTPD) system
  • Robust DOE platform
  • Standardized downstream unit operations and platform processes
  • Clarification development (depth filtration, centrifugation, TFF)
  • Chromatography purification optimization (Affinity, IEX, , HIC and Mixed Mode)
  • Chromatography resin dynamic binding capacity studies
  • Chromatography resin lifetime, aging and cleaning studies
  • Viral inactivation and virus removal filtration development
  • Scale-down process characterization for viral clearance studies and process characterization
  • Scale-up
  • Risk analysis & cost benefit for various purification process unit operations

Depending on our clients’ needs, the downstream process development team can quickly establish a manufacturing process based on our existing, robust downstream MAb platform, which currently has 50-70% product yield with acceptable characteristics and low levels of product and process impurities (aggregates, DNA <10 ppb, HCP < 100 ppm etc). Likewise, we offer the flexibility to transfer, develop and optimize client-specific processes for either MAbs or proteins, or to customize the process to meet special requests for product quality, such as the adjustment of charge distribution ratio for a biosimilar product.

For late-stage processes and programs, we can design and execute process characterization, optimization and validation, and assist in the CMC section filing process.

We offer our clients significant advantages at every stage of downstream development – from process design and optimization of individual unit operation to scale-up, non-GMP manufacturing and technical transfer for GMP production.

Technologies and Equipment

Chromatography

  • Affinity Chromatography (AC)
  • Ion Exchange Chromatography (IEX)
  • Hydrophobic Interaction Chromatography (HIC)
  • Mixed Mode Chromatography

Filtration and Centrifugation

  • Continuous Centrifuge
  • Depth Filtration
  • Single – Pass Tangential Flow Filtration
  • Ultrafiltration and Diafiltration

Viral Inactivation and Removal

  • Low pH or Detergent Treatment
  • Nanofiltration
  • Chromatography

Extensive Capacity

WuXi Biologics operates and maintains over 40 different purification systems for use in downstream process development.  This capacity helps ensure that we can provide our services in a time efficient way.  Systems include (but not limited to):

  • ÄKTAprocess
  • ÄKTA ready
  • ÄKTApilot
  • ÄKTA avant
  • ÄKTAexplorer
  • ÄKTAprime plus
  • Depth Filtration System
  • Ultrafiltration/Diafiltration System
  • Automatic Tangential Flow Filtration System
  • ÄKTA cross flow
  • Alfa Lava Centrifuge
BACK