CDMO Capabilities

 

cGMPManufacturing

With a single-use upstream suite (200L and 2000L), two viral segregated downstream suites and partnered fill-finish capabilities in the U.S. and Asia, Oncobiologics offers a comprehensive end-to-end solution.

  • Manufacturing flexibility, achieved through single-use technology allowing for 200L and 2000L upstream production capabilities
  • State-of-the-art facility encompasses viral segregated Purification suites, following cGMPguidelines
  • Operational proficiency to perform campaign-based cell banking operations with controlled rate freezes
  • Single-Use Bioreactors can be modified rapidly to match an existing or new process design with little to no impact to the operational timelines
  • Planned future expansion and increase in capability to meet global demand while minimizing idle capacity
  • Facility can be replicated globally to address supply chain needs

Partnered Fill-Finish

Our partnered fill-finish capabilities enable turnkey filling of vials, cartridges, and pre-filled syringes, as well as lyophilization and antibody drug conjugation.

Low Production Costs by Design

  • Significant lower capital investment relative to stainless steel facilities
  • Minimal Upstream product change over requirements, utilizing single-use technology
  • Reduced Cleaning and Sterilization validation, utilizing single-use technology

 

Process Development

Upstream and downstream process development utilizes high throughput methods to optimize cell line productivity, media/feed strategies, and purification processes, from microbioreactorsto 200L pilot scale.

High Throughput Development

  • ambr® 15-mL for Clone Selection & Media Development
  • 96-well Resin Screening & Mobile Phase Screening
  • Dynamic Light Scattering & Cap DSC used for Formulation Screening

Process Design

  • 16x5-L Bioreactors & Shake Flasks
  • 2xAKTA Explorers; 2xAKTA Avant; 1 AKTA Pilot
  • Process Parameter Establishment
  • Scale Down Model for Design Space Characterization
  • Stability (Real Time and Accelerated)

Pilot Scale Demonstration

  • 200-L Single-Use Bioreactor and 10 cm diameter columns
  • Process Verification
  • Process Consistency

 


 

Cell & Molecular Biology

Our C&MB team offers cell line development and utilizes automated technologies to efficiently screen thousands of clones.

  • Quarantine Suite with pass-thru
  • Cell Bank Storage
  • Cloning Lab (separates PCR and microbial work)
  • Octet and UPLC
  • FACS and CeligoImager
  • CHO and HybridomaHosts

 

Analytics & Formulations Development

Analytical and formulation development capabilities are core strengths that enable comprehensive characterization and quality testing.

 

Analytical Capabilities

  • State-of-the-Art Instrumentation to drive protein characterization and stability
  • HPLC/UPLC based methodologies
  • Glycan profiling
  • ELISA for cell-based assays and residual impurity assessments
  • Electrophoretic methodologies (gel and capillary based)
  • Cell-based Bioassay development and characterization
  • SPR methodologies (Biacore)
  • Mass Spectrometry (Orbitrap): accurate and precise assessment of post-translational modifications
  • Fluorescence microscopy
  • Higher order structure and stability profiling in 96-well plate format
  • Investigation of multiple modes of product degradation for complete product profiling
  • Electronic Lab Notebook

 


 

Formulations Capabilities

  • Micro-Flow Imaging – particle analysis
  • DSC, Light scattering, spectroscopy, FTIR
  • Stage Appropriate Drug Product and Formulation Development
  • Development of Drug Product in Pre-Filled Syringes and Vials
  • Shipping and Storage Studies to support long term stability of formulation
  • Identification of Formulation/Stabilizing Conditions using DOE and Material Sparing Approaches

 


 

Regulatory & Clinical Development

Oncobiologics’ regulatory team has experience leading multiple biologics through development and regulatory approvals. We believe our strategy mitigates regulatory risk while supporting speed of development. Our expert clinical team provides overall clinical program oversight as well as management of external study vendors, coordination of clinical supplies, and works with our regulatory team to ensure proper clinical trial regulatory submissions. 


 

Quality

Our Quality Management System meets the requirements of EMA and US FDA regulations and our facilities and systems have been reviewed/ approved by Qualified Persons and former FDA Inspectors.


 

Program Management

Our program managers play a critical role in communicating with clients and engaging all internal functional groups to ensure that all programs run smoothly, efficiently and on-time.