Hong Kong Institute of Biotechnology (HKIB)

		Home	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

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

or by fill in the form below:

Name:		Title:
Company/
Organization :
Address:
Street:
City:
Country:		Postal Code:
Telephone:		Mobile:
Fax:		Email:
Information Required:

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