Integrated Process Development for Biologics
Comprehensive upstream and downstream process development from cell line to fill-finish — accelerating your biologics from DNA to GMP production.
Cell Line Development
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MeCHOta® Host Cell Platform
Our proprietary CHO cell line is derived from ECACC CHO-K1 and adapted for high-performance suspension culture.
Key Features:
Globally authorized with full traceability and regulatory compliance
Comprehensive cell banking and testing solutions
Matched expression vectors and media for high-yield, scalable expression
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High-Expressing Cell Line Construction
We deliver production-ready clones in ~20 weeks with titers reaching up to 9 g/L
From gene synthesis to stable pool and clonal selection
Customizable workflow using our MeCHOta® platform or client-provided hosts
Upstream & Downstream Process
Development
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Platform-Based Development Strategy
Platform-Based Development Strategy
Our process development follows scalable, phase-appropriate strategies optimized for regulatory compliance and tech transfer.
• Fed-batch and perfusion process optimization in scalable bioreactors
• Platform purification processes including Protein A, ion exchange, and polishing steps
• Process parameter definition aligned with CMC and QbD principlesAdvantage：
Reduced development timeline via standardized modules
Scalable from 2L to 200L pilot runs
Compatible with cGMP production workflows
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Transferable and Scalable from Lab to Clinic
Transferable and Scalable from Lab to Clinic
HiLand's integrated PD platform ensures:
• Seamless transition from research-grade to GMP manufacturing
• IND-enabling material supply
• Flexibility for mAbs, BsAbs, ADCs, and fusion proteins
Formulation Development
Comprehensive formulation capabilities & expertise across a wide range of biologic modalities:
Monoclonal antibodies, bispecifics, fusion proteins, nanobodies
Both liquid and lyophilized formulations
Support for IND-enabling studies and long-term stability programs
Formulation Screening
Formulation selection and early formulation development；
Formulation screening with DOE design；
Influencing factor experiment/stability study；
Selection of excipients and packaging materials
Formulation Screening
Formulation selection and early formulation development；
Formulation screening with DOE design；
Influencing factor experiment/stability study；
Selection of excipients and packaging materials
Formulation-Supporting Studies
Compatibility studies of excipients and packaging materials, and container closure integrity;
Freeze-thaw, agitation, photostability, and stress testing
Formulation-Supporting Studies
Compatibility studies of excipients and packaging materials, and container closure integrity;
Freeze-thaw, agitation, photostability, and stress testing
Fill-Finish Development
Identification of suitable fill-finish process strategy；
QbD-based process optimization & qualification；
Scale-up for vial and PFS formats, including tech transfer readiness
Fill-Finish Development
Identification of suitable fill-finish process strategy；
QbD-based process optimization & qualification；
Scale-up for vial and PFS formats, including tech transfer readiness
Protein Analysis & Assay Development
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Assay Development Services
Assay Development Services
We support full assay development for release, stability, and comparability studies.
Categories include:
Structural and physicochemical characterization
Biological activity assays
Product release testing aligned with regulatory guidelines -
Platform Capabilities
Platform Capabilities
HPLC/UPLC related: titer HPLC, SEC HPLC, CEX HPLC, peptide mapping, glycosylation, DAR value, sialic acid, extinction coefficient, tween；
CE related: iCIEF, CIEF, rCE SDS, nrCE SDS, CZE;
ELISA related: antigen binding, residual HCP, residual Protein A, residual insulin；
PCR related: residual HCD, copy number;
BLI related: affinity, FcγRIa / FcγRIIa / FcγRIIb / FcγRIIIa / FcγRIIIb / FcRn / C1q binding;
Cell assay related: cell-based bioactivity, ADCC, ADCP, CDC;
MS related: denatured and non-denatured molecular weight, peptide mapping, disulfide bond, post-translational modifications, glycosylation site, conjugation site, sequence coverage, de novo sequencing
