Home » Biologics CDMO » IND-enabling CMC
Fast to Clinic

Fast to Clinic

  • mAb Fast CMC: 6 months from Sequence to Tox batch release
  • bsAb Fast CMC: As fast as 7 months from Sequence to Tox batch release
ProBox<sup>TM</sup> Process Development Tool Box

ProBoxTM Process Development Tool Box

  • Solutions for challenging problems with our expertise on the knowledge of protein structures and quality attributes

Customized Solutions for mAb,BsAb,Protein

Customized Solutions for mAb,BsAb,Protein

  • 3 Processes: fed-batch, high density inoculation and perfusion process according to different molecules
  • Analyticial & bioassay method development for mAb,bsAb,protein
Host Cell Commercial License

Host Cell Commercial License

  • Wide type CHOK1-GenS and ADCC enhanced CHOK1-ADCC+ cell license to be chosen
  • Combo license at discounted price
  • Royalty free

IND-enabling CMC Development Platform

  • mAb Fast CMC

    mAb Fast CMC
    For mAb, Naked Ab of ADC

    6 months from Sequence to Tox batch release

  • bsAb Fast CMC

    bsAb Fast CMC
    For bsAb

    As fast as 7 months from Sequence to Tox batch release

  • Intensified CMC

    Intensified CMC
    For bsAb, Protein

    9 months from Sequence to Tox batch release

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
Seed Train Upstream Process Features Culture Longevity (Seed-Harvest) Max VCD Typical Titer
Standard CMC Conv. Seed Train
Conv. Seed Train
  • Serves as a back-up for all following processes
25-30 Days 20-30 M/mL 3-5 g/L
Intensified CMC Conv. banking
Conv. banking
N-1 Per. Seed Train
  • 3-10 M/mL Inoc. shorter biomass growth phase
  • Easy to adopt
30-35 Days 30-50 M/mL 7-9 g/L

Intensified CMC Significantly Brings Titer Improvement

80% projects titer increase between 80%-150%

Intensified CMC Significantly Brings Titer Improvement
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

Quotations and Ordering

To request a quotation, please contact us via our secure online messaging system.