Antibody Drug IND

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Stable cell line construction


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Upstream process development


  • 12 sets of 3L reactors, 4 sets of 10L reactors
  • Increase in expression (evaluation data for expression of 106 items)
  • Regulation of glycosylation (glycosylation data of 106 items)
  • CEX adjustment (cief data of 106 items)
  • ADCC improvement (transient 048 data)

Downstream process development

        It has a mature protein purification preparation process platform, equipped with intelligent protein chromatography purification system such as AKTA Pure and Avant, and a pilot purification system compatible with 200L cell culture scale. It has process development for protein drugs such as monoclonal antibodies and fusion proteins. Experienced. According to customer needs, we can develop protein purification preparation processes that meet the requirements of relevant Chinese and international regulations to ensure that the process meets the needs of industrialization amplification.

  • Chromatography process development and optimization (filler screening, buffer system screening, dynamic capacity screening, etc.)
  • Microfiltration, ultrafiltration and other process development
  • In addition to virus process development (low pH incubation, S/D treatment, nanofiltration)
  • Pilot level purification process amplification and confirmation

Analytical method development

        Analytical development and detection platform with advanced instruments such as Waters H-Class UPLC, Waters ARC UHPLC, Agilent 1290 Infinity, Agilent 1260 Infinity, Protein Simple Maurice, Tecan INFINITE 200 PRO, Biorad realtime PCR, etc. Accroding to regulatory requirements,we can provided monoclonal antibodies and fusion proteins, etc. for the development, validation and validation of analytical methods, as well as the provision of quality testing for clinical trials for pilot production.

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Formulation method development

        Using platform technology, based on the protein characteristics of different projects, quickly and efficiently screening appropriate formulation prescriptions, preliminary evaluation of product stability.Investigating the suitability and sealing of packaging materials, developing and confirming the preparation production process. According to the requirements of regulations, the influencing factors (light, vibration, freeze-thaw, etc.), acceleration and long-term stability tests were carried out.

  • UNCLE high-throughput preformulation research
  • Formulation development
  • Confirm container closure system
  • Confirm formulation
  • Manufacturer process development

Pilot production

        The GMP pilot plant, equipped with Thermo 250L to 1000L disposable reactors, ATKA ProcSS purification equipment, and Sartorius storage and distribution system, can provide pilot batch production services required for IND applications. The types of samples available for pilot production include antibodies, recombinant proteins and antibody-conjugated drugs.

Case Study

CHO DG44 Project cho dg44 CHO-K1 Project Cho-K1
Project Overview
  • Format: mAb
  • Timeline from transfection to top clones: 18 weeks
  • Top Pool: 0.5 g/L, Top Clone in Spin Tune: 3.8 g/L, Top Clone in Bioreactor: 4.6 g/L
  • Project status: Phase I
Clonality
Top Clones

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Process Optimization in Bioreactor: pH, temperature shift, seed density etc.
Project Overview
  • Format: Fc-Fusion
  • Timeline from transfection to top clones: 13 weeks
  • Top Pool: 1.9 g/L, Top Clone in Spin Tune: 3.4 g/L, Top Clone in Bioreactor: 7.5 g/L
  • Commercial CD Basal and Feed Medium
  • Project status: Scale –up & 3-batch Production
Cell Culture Process Optimization