IND-enabling CMC Service

√ 6 months from sequence to Tox DS release
√ 12 months from sequence to IND
√ 0.5kg/200L, 1.2kg/500L GMP DS is guaranteed to deliver

Applicable to symmetrical bispecific antibody：
√ 7 months from sequence to Tox DS release
√ 13 months from sequence to IND

Applicable to asymmetrical bispecific antibody：
√ 8.5 months from sequence to Tox DS release
√ 14.5 months from sequence to IND

Intensified CMC Highlights

• High density inoculation technology
• Easy to have 30%-150% titer improvement compared to standard CMC
• 30%-50% manufacturing cost down per gram of Ab
• Friendly differential pricing according to titer improvement

Intensified CMC Significantly Brings Titer Improvement

80% projects titer increase between 80%-150%

√ ProBox^TM -process development tool box is build based on ProBio’s ~100 CMC project experience and it classifies, summarizes and integrates ~200 technical challenges and solutions in process development and analytical development.

√ The ProBox^TM is updated in real time to help process researchers better cope with new process development challenges.

√ In addition, ProBox^TM  analyzes multiple types of bispecific antibodies and proteins and summarizes the challenges and solutions based on the understanding of their structure and quality attributes.

Supporting the Full Lifecycle of Biologics Development

• Versatile Analytical Procedures

  • General properties: UV280, AAA, pH, Osmolality, Color, Clarity, etc.
  • Structural characterization: LC-MS, CD, DLS, DSC, etc.
  • Product-related impurities: SEC/CEX/HIC/RP-HPLC, CE-SDS, icIEF, etc.
  • Process-related impurities: HCDNA, HCP, rProteinA, Endotoxin, Bioburden, etc.
  • Bioactivities: ELISA binding and Cell-based assay, ADCC, CDC, ADCP, MLR, Fc-binding

• Strong Capability in Method Development

  • Experience of >10 kinds of CMC biologics, including mAb, bsAb, tsAb, scFv, hILs, coagulation factors, protein complex, and many other specially designed molecules.
  • Dedicated cell line engineering team to develop cell line based on target MOA
  • Can start method development as early as possible (e.g. cell pool stage)

• Hardware and Software

  • Powerful instruments: 2 mass spectrometers (QE Orbitrap and Q-TOF), UHPLC systems of mainstream brands (Agilent/Waters/Thermo), CE systems (PA800 plus, Maurice, etc.), Microplate readers (Molecular Devices)
  • Software meets compliance: Audit trails available, with GMP, GLP, and 21 CFR Part 11 compliance

Determine the Biological Potency of Broad Types of Targets

Cell-based assay Dev. Capability

• Dedicated cell line engineering team to develop cell line based on target MOA
• Experience of >30 targets, multiple off-the-shelf cell lines to support IND/BLA filing
• In compliance with ICH and USP to perform method development, optimization and validation.
• Clear background and traceability of cell line, which is compliant with authority regulation

Different kinds of targets

• mAb, bsAb, recombinant protein, Cytokine, T-cell engager
• Immune checkpoints, tumor-associated antigens, inflammation factors, cytokines, coagulation factors, GPCRs
• Anti-cell proliferation, apoptosis, T cell activation, cytokine release, neutralization, etc.

Platforms for characterization

• ADCC, CDC, ADCP, Mixed Lymphocyte Reaction
• Fc-binding
• FcγRIIIA (CD16a) 158V, FcγRIIIA (CD16a) 158F, FcγRIIA (CD32a) 131H, FcγRIIA (CD32a) 131R
• FcγRI (CD64), FcRn, C1q