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Downstream Processing

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Producing safe and effective biologics for tomorrow

The Downstream Processing group purifies and analyses the quality of bio-products. At the frontier of bioprocessing technologies, we are passionate about delivering innovative purification solutions to support the development of biologics research. Our work is coupled with appropriate in-process monitoring and major CQA analyses for any processing scales. We aim to enhance conventional purification strategies and develop novel purification platforms for biologics.

Focus Areas

  • Purification process development for monoclonal antibody, bispecific antibody recombinant protein, vaccine, viral vector, and nucleic acid
  • In-process monitoring and major CQA analysis for monoclonal antibody, bispecific antibody recombinant protein, vaccine, viral vector, and nucleic acid
  • Continuous and intensified downstream processing


Our Capabilities

Extensive and in-depth expertise in purification of traditional and emerging modalities

Bispecific Antibody

Bispecific Antibody

  • Fragment based
  • Asymmetric formats
  • Appended IgGs

Antibody

Antibody

  • IgG
  • IgM

Nucleic Acid

Nucleic Acid

  • Linear mRNA
  • Circular mRNA
  • Supercoiled pDNA
  • Linearised pDNA

Recombinant Protein

Recombinant Protein

  • Insulin
  • Alpha-1 Antitrypsin

Vaccine

Vaccine

  • H1N1
  • Virus-like-particle

Viral Vector Gene Therapy

Viral Vector, Gene Therapy

  • AAV 1, 2, 5, 6, 8, 9 and DJ



Downstream process development

DSP Systems
  • Purification process development from high throughput scale to pilot scale for bio-products


Analytics and Characterisation

UHPLC

UHPLC

  • UV-Vis
  • CAD
  • Fluorescence
  • MALS
  • RI

Sample Concentration

Sample concentration

  • UV
  • Fluorescence
  • Slope Spectroscopy

Nucleic acid amplification

Nucleic acid amplification

  • qPCR
  • dPCR
  • ddPCR
  • RT-PCR

Assays

Assays

  • CE-SDS
  • Endotoxin test
  • Host cell protein
  • Total protein

Size measurement

Size measurement

  • NTA
  • DLS

Turbidimetry

Turbidimetry

  • Turbidity meter

Molecular stability

Molecular stability

  • DSC

Gel electrophoresis

Gel electrophoresis

  • Protein/ nucleic acid
  • Native/denatured


Our Technologies

  • We have established purification platforms with improved recovery, product purity and increased cost-effectiveness for both traditional and emerging modalities
  • We offer comprehensive analytical platforms for in-process monitoring and final product QC to accelerate process development and ensure product quality and safety.
  • Several patents and technological know-hows have been licensed to companies

Bispecific antibody purification platform

Bispecific antibody purification platform

Integrated biologics purification platform

Integrated biologics purification platform

pDNA and mRNA purification platform

pDNA and mRNA purification platform

AAV purification platform

AAV purification platform

Our Track Record

Featured publications:

  • Serene W Chen, Zi Ying Zheng, Farouq Bin Mahfut, Yuansheng Yang, Masahiro Ogino, Kazuo Okada, Kohei Sato and Wei Zhang (2023) Leveraging an advanced simulated moving bed approach to achieve 3-component separation for enhanced impurity removal in a non-affinity cation exchange capture step. PLoS ONE 18(1): e0280760
  • Serene Chen, Hoi Kong Meng, Yang Yuansheng and Zhang Wei (2022) Excellent removal of knob‑into‑hole bispecific antibody byproducts and impurities in a single‑capture chromatography. Bioresources and Bioprocessing 9: 72
  • Siew Yin Yin, Amrita Rai, Han Bin Pek, Dave Siak-Wei Ow and Zhang Wei (2021) New and efficient purification process for recombinant human insulin produced in Escherichia coli. Applied Microbiology and Biotechnology 105(24): 9137-9151
  • Duy Tien Ta, Kai Ling Chu, Nur Izzati Bte Soonaan, Christine Chin, Say Kong Ng and Wei Zhang (2021) A new and simplified anion exchange chromatographic process for the purification of cell-grown influenza A H1N1 virus. Separation and Purification Technology 263: 118412
  • Serene W Chen, Darryl Tan, Yuan Sheng Yang and Wei Zhang (2020) Investigation of the effect of salt additives in Protein L affinity chromatography for the purification of tandem single-chain variable fragment bispecific antibodies. mAbs 12 (1): 1718440

The Team

Dr Zhang Wei

Dr Zhang Wei

zhang_wei@bti.a-star.edu.sg
Principal Scientist I

PhD in Chemical and Pharmaceutical Engineering (2011), Singapore-MIT Alliance, National University of Singapore, Singapore

Research Focus / Interest
  • Purification process and analytics development for biologics, vaccines, cell and gene therapy, and nucleic acid therapy
  • Continuous and intensified downstream processing
  • Process scaling up and technical transfer to GMP facility

Desmond Heng

Dr Desmond Heng

desmond_heng@bti.a-star.edu.sg
Senior Scientist II

PhD in Pharmacy (2009), University of Sydney, Australia

Research Focus / Interest
  • Biologics formulation
  • Biotherapeutic delivery
  • Drying technologies
  • Stability studies and shelf-life improvement
  • Medical devices

Nattha Ingavat

Dr Nattha Ingavat

nattha_ingavat@bti.a-star.edu.sg
Senior Scientist I

PhD in Department of Chemistry (2017), Johns Hopkins University, Maryland, USA

Research Focus / Interest
  • Antibody (Bispecific antibodies) purification and characterization

Siew Yin Yin

Dr Siew Yin Yin

siew_yin_yin@bti.a-star.edu.sg
Senior Scientist I

PhD in Pharmacy (2016), National University of Singapore, Singapore

Research Focus / Interest
  • Biotherapeutics purification and characterization

Patric Chua

Dr Patric Chua

patric_chua@bti.a-star.edu.sg
Scientist

PhD in Microbiology (2017), Monash University, Australia

Research Focus / Interest
  • Recombinant Adeno-associated Virus (AAV) purification and characterisation

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