Applying deep industry knowledge and data-driven
solutions to biologics design and manufacturing

J.DESIGN is an in-house, integrated technology platform. Utilizing J.DESIGN we are able to accelerate development and provide superior manufacturing process control for higher quality molecules at the lowest possible cost.

At the core of J.DESIGN is a common data management system that centralizes and integrates the highly complex data sets generated from the distinct activities involved with the development and manufacture of biologics – Molecular Design, Process Design, and Manufacturing Design – into a singular biologics design space.

  • Native antibody sequences are improved to enhance manufacturability and stability
  • Abacus is an in-house suite of proprietary computational tools that enable prediction of the best molecules and conditions for development
  • Product candidates are evaluated using assays that indicate how well a molecule is expressed, purified and formulated
  • Learnings from each molecule are used to improve the toolset for future molecules

  • Proprietary cell lines, vectors, and media with process options for fed-batch, intensified fed-batch, and continuous culture
  • Chromatography, filtration, and viral clearance capabilities for removal of impurities
  • Biophysical and formulation development tools for defining optimal storage stability
  • High resolution analytical capabilities, including mass spectrometry based multi-attribute method (MAM)

  • Disposable technologies and intensified processes to create a flexible, deployable, and relatively low cost biomanufacturing facility
  • Small, intensified bioprocessing is housed inside Pod™ cleanrooms to reduce expensive manufacturing space and overall plant size
  • Commercial Pod™ facility under construction with affiliate company Hangzhou Just
  • Unit operations are identical to J.PLANT facility located in Seattle WA to alleviate scale-up and minimize transfer risk

Process Development and Technology Transfer

    Our Services

  • Establish partner joined-committee and PM; set goals, roles, responsibility and update mechanism
  • Small scale documentation transfer: Process description and method procedures
  • Technical team workshop
  • Cell bank establishment and stability
  • Assay transfer and qualification/validation
  • Scale up process and procedures, documentation for Tech transfer to mfg.
  • QA & QC review
  • Process optimization and validation
  • Support pilot/large scale runs 200 - 1000L
  • Formulation optimization

Manufacturing Facility and Capability

  • Multi-product capability
  • Currently two cell culture suites
  • Two 500L SUB
  • Support perfusion and fed-batch processes
  • Can produce GMP batches in scales of 200L, 500L and 1000L (pooling)
  • Plan to add 2 X 2000L CC suite in 2018/19
  • Separate pre and post viral suites
  • Single use disposable technology
  • Delta V for process automation
Functions
  • QC capability
  • Analytical method optimization, transfer, qualification and validation
  • In-process control, DS & DP lot release test
  • GMP stability studies
  • Environmental monitoring and PW, WFI, Clean Steam testing
  • Raw material release testing
  • Labware LIMS
laboratory
  • QC lab functional areas
  • Bioassay lab
  • Analytical lab
  • Micro lab
  • Stability Room
  • Preparation Room
  • Sample retention Room
  • Wash room & Autoclave room
  • Clean Area including Bioburden Test, Sterility Test, Cultivation Positive Test

Quality Management System

7 main systems to ensure the quality

Quality Management System strictly follows prescribed protocols
Rigorous GMP standards ensures excellent quality
ComplianceQuest (CQ) provides a GMP compliant computer system environment for QMS

COMO Services Scope

For more information, please contact us at cdmo@justbiochina.com