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Site Index

       
   
 

 
 
   
 
   
 
 
 
 
 
 
 
 
 
 
 
   
 
   
  Introduction
   
  The Biologics Unit was established with project grants from the Innovation & Technology Commission (known as “Industry Department” in the past) of the Hong Kong SAR Government with the purpose of building a state-of-the-art facility (see more for our facilities facty sheet) and operation expertise unique in Hong Kong for use by the biotechnology industry from Hong Kong and other Asian region. Biotech start-up companies will find this arrangement beneficial because they do not need to invest heavily on capital equipment, manpower on one hand and at the same time cut down costs like depreciation, instrument maintenance to the minimum.
 
 
 
 
 
 
   
  Being a unit of a non-profit making organization, we provide our service on a cost-recovery and pay-per-use basis.
 
   
  Our unit has three major service areas:
   
  (1) process development from laboratory to pilot scale,
   
  (2) production of commercially unavailable biomass and biomolecules at a pilot scale as tools for biomedical research and as active pharmaceutical ingredients for clinical studies, and
   
  (3) production of generic biopharmaceuticals (biogenerics) for supply to the less developed market including China. We also act as a technology platform for developing prospective products resulting from pure research to bring them into the clinical research arena.
 
   
  Process Development
   
  The goal is to devise a process suitable for cGMP manufacturing that establishes procedures to minimize manufacturing downtime, streamline scale-up and maximize product yield and product purity. Process development services include molecular biology, media optimization, scale-up of fermentation and bioreactor runs, product recovery and purification design and product assay. Through collaboration with our strategic partners we can provide help in selection of an appropriate production system (bacteria, yeast, insect cells, mammalian cells) and cell line development (from cloning to GMP cell banking).
 
 
 
 
 
 
   
 
Molecular Biology
Upstream Process Development
Downstream Process Development
     
Plasmid modifications Microbial expression systems Chromatographic purification
  and mammalian expression  
New construct systems Tangential flow filtration
development    
  Pichia pastoris, Escherichia coli, Assay qualification
Strain / Plasmid insect cell, Chinese Hamster  
characterization Ovary (CHO) cell Protein characterization
     
Screening of production Microbial fermentation  
strains    
  Cell culture bioreactors  
Comparability studies    
(Strain and product) Monoclonal antibodies  
     
  Media optimization /  
  development  
     
  Product recovery  
     
  Concentration  
     
  Protein refolding (inclusion  
  body systems)  
  Table 1: Service scope of process development
 
   
  Contract Manufacturing
   
  We offer the service for manufacturing of therapeutics, vaccines, plasmid DNA and diagnostics up to demonstration batch. Our unique expertise allows us to focus primarily on protein-based target that can mostly be produced by bioreactors and large-scale fermenters. The following table summarizes our current service areas.
 
 
 
   
 
Sub-class
Recombinant DNA-based Drug Substance
               
Monoclonal Antibodies
             
Nucleic Acid, Fungus
               
Attenuated Microbial Cell
             
Live Microbial Vector
               
DNA Vaccine                            
Purified Protein              
Conjugated Polysaccharides                            
Live Attenuated Viruses                            
Multiple Antigen Peptide Vaccines                            
Virus-like Particles                            
Live Viral Vectors                            
Bacterial Preparation                            
Antitoxins / Antisera                            
Blood Products                            
Cytokines
                 
Probiotics
                       
Hormones
               

Components of Protein in Nature

               
Components of Protein in Nature
               
   
  Table 2: Summary of our service along the production chain
 
   
  Bio-analytical Laboratory Service
   
  We offer a wide range of laboratory testing service with our in-house array of state-of-the-art analytical instruments. These tests are available to ensure the quality of your vector / host system before protein expression and your end-product after purification.
 
 
   
 
Tests Before Process Development / Production* Tests after Process Development / Production*

· Characterization of prokaryotic cell

· Characterization of eukaryotic cell lines

· PCR-based bio-safety test

· Phage testing

· Copy number testing

· Bacterial endotoxin

· Mycoplasmas

· Sterility test

· SDS-PAGE

· Determination of isoelectric point

· N-terminal protein sequencing

· Amino acid analysis

· Ultra-violet spectrum determination

· Total organic carbon

· Residual DNA impurities

· Residual host cell protein

· Viral clearance

· Bacterial endotoxin

· Mycoplasmas

· Pyrogen

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
  *Customized tests are available with advanced instrumentation (e.g. MALDI-TOF/TOF, X-ray analysis) that are available at Department of Biochemistry, CUHK.
   
  Table 3: Summary of Bio-analyical Laboratory Service
 
   
  For-fee Facility Access Service
   
  The establishment of a biotechnology product development / production company requires an intensive amount of capital for equipment. Some experiments need to be conducted in a specialized laboratory and the maintenance fee for such a facility can be another financial burden particularly for newly formed biotech companies. To help you out, we have a set of facilities that are open to client for leasing. You can find a full list of our facilities in another leaflet Biologics Unit Fact Sheet.
 
   
  Profile of Target Collaboration
   
  Our manufacturing facility was GMP-certified by the Therapeutic Goods Administration (TGA) in Australia in 1998.
 
   
 
  (Click to view our TGA Certificate of Manufacturing Facility)
   
  Currently we focus our effort on non-GMP process development and non-GMP production. We will proceed to attain GMP qualification from the SFDA (State Food & Drug Administration, Peoples’ Republic of China) and TGA in the coming few years.
 
 
   
   
 
.
Process / Purification Development
Non-GMP pilot-scale production
GMP Pre-clinical production
GMP clinical trial production
GMP commercial batch production
University Research
TBA
TBA
No
Entrepreneur Projects
TBA
TBA
TBA
Biotech Start-up Companies
TBA
TBA
TBA
Biopharmaceutical Companies
TBA
TBA
TBA
  TBA = to be available
   
  Table 4: Profile of Target Collaboration
 
   
  Successful Stories
   
  We successfully completed a number of research and production projects like:
   
  - GMP production of anti-malaria vaccine candidate TBV25H for Phase I & II clinical trial for the World Health Organization (WHO) and the National Institutes of Health, USA;
 
 
  - Production of veterinary vaccine recombinant paramyocin against Schistosomiasis for the Queensland Institute of Medical Research, Australia;
 
 
  - GMP production of malaria blood-stage vaccine P30P2-MSP1 for the National Institutes of Health, USA;
 
 
  - Production of a drug-screening enzyme for F. Hoffman-La Roche, Switzerland.
 
   
  Intellectual Property Policy
   
  Your intellectual properties will be strictly protected by a mechanism that is completely
  separate from those of the Chinese University of Hong Kong. A non-disclosure agreement
  between the related parties will be signed before any transfer of material and technical
  know-how. Being a subsidiary of a university, we will firmly uphold the standard and policy
  without any compromise.
   
  Talk to us and explore this opportunity to make better use of your money for your R&D
  projects.
 
  Video
   
 

Biologics

 
  Enquiry
   
  You can contact us directly by mailing to .
   
 
 
The Hong Kong Institute of Biotechnology Limited.
2 Biotechnology Avenue, 12 Miles, Tai Po Road, Shatin, N.T., Hong Kong. Tel: (852) 26035111, Fax: (852) 26035012
Copyright 2005 © The Hong Kong Institute of Biotechnology Limited. All rights reserved.