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IND-enabling CMC

IND-enabling CMC Service

Developing high-producing and robust processes

IND-enabling Process Development Services

With team of experienced scientists and proprietary development platform, GenScript ProBio provides custom services for upstream process development, ranging from optimizing Cell growth Process Development Service, screening production media, defining feeding strategies, to studying clone stability, and further scale-up to pilot and commercial production. We also offer a thorough analysis of growth rate, subcultivation ratios, cell mass, and other parameters. Upon request, we can perform additional specific process optimization studies or employ our scaled-down models to predict cell performance.

GenScript ProBio offers services for purification process development. For downstream process, Preclinical CMC protein purification is typically conducted through affinity columns. We also offer other chromatographic methods including gel filtration, ion exchange, and hydrophobic interactions. The purification tags are removed via a specific protease if desired, and the protein is further purified by gel filtration.

Fast to Clinic

Fast to Clinic

10 months from DNA to GMP batch
Integrated CMC platform
Balance between Time & Quality

Quality Focus

Quality Focus

Multi-dimensional support in PM, RA and MSAT
Provide fed-batch, high density inoculation and perfusion process according to different molecules

Guarantee Delivery

Guarantee Delivery

Multiple IND cases
Compliant to FDA/EMA/NMPA regulation
Proven success in challenging molecules

Flexible Business Model

Flexible Business Model

Risk & Sharing with clients
Convenient CHO-K1 Commercial License

Speed to Clinic

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
30-35 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
20-25 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

Robust and efficient production processes are crucial to the success of IND-Enabling studies and to the preservation of product competitiveness. GenScript ProBio's ‘Time & Quality-Balanced’ process development strategy, including using cell pool samples for purification preliminary development and cell culture process optimization, 3L samples for purification process optimization and formulation development, and 10/50L samples for process scale-up and purification process lock greatly shortens the process development timeline.

Media Screening
Clone & Media Selection
Process Bioreactor
10L or 50L Scale-Up

GenScript ProBio has developed a mature antibody purification platform process that allows clients to quickly establish a production process with an overall recovery rate of around 70% and with acceptable product characteristics, process and product-related impurities. GenScript ProBio will customize the processes to meet the unique needs of each client. For example , in the case of biosimilars, GenScript ProBio has effective techniques and tools to change the distribution of product glycoforms and charge isomers. In the case of recombinant protein with low stability, GenScript ProBio has developed different DoE tool boxes to ensure the titer and yield.

Chromatography Filtration and Centrifugation Virus Inactivation and Clearance
  • Affinity Chromatography (AC)
  • Ion-exchange Chromatography(IEX)
  • Hydrophobic Interaction Chromatography (HIC)
  • Deep Filtration
  • Tangential Flow Filtration (TFF)
  • Ultrafiltration and Liquor Exchange
  • Low pH inactivation and detergent treatment
  • Nanofiltration (NF)
  • Chromatography
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 toll-free phone, email, fax, or our secure online messaging system. Our customer service representatives are available 24 hours a day, Monday through Friday to assist you.