Hong Kong Institute of Biotechnology (HKIB)

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Introduction

The unit was formed in November 1999 and subsequently built up its existing facilities by funding from the Innovation & Technology Commission of the Hong Kong SAR Government. The aim of the unit was to establish a central facility for the research, development and manufacturing of safe and high quality Chinese medicinal products in compliance to GMP guidelines and to support the development and upgrade of the local Chinese medicine industry.

Presently, the unit consists of four sections, Quality Assurance, Quality Control, Production, and Marketing which are staffed by well-experienced professionals. Our facility is not only a pilot production plant capable of producing Chinese medicinal extract powder from herbal raw materials through extraction, concentration and spray-drying but also a full scale solid dosage formulation facility to manufacture sachet, tablet and capsule products for test trial and commercial uses.

Since the inception of the TCM unit, a total of 40 Chinese medicine products have been developed, some of which were traditionally used or Pharmacopoeia formulations while otherswere OEM products for our clients. In November 2003, we have registered our Trademark - LifeArt ^TMand launched the first product, e-Shops. We have collaborated with 3 local companies to launch products under their brand names. A total of 16 proprietary Chinese medicines have been registered with the Department of Health of Hong Kong in June 2004.

Our Facilities

The Process Development and Manufacturing Facility of the TCM unit was designed to comply with international GMP standard. It consists of different functional rooms including raw material warehouses, sampling room, weighing room, manufacturing facility, outer packaging room, printing room, finished product warehouses, sample retention room, QA office and QC laboratories that covered a total floor area of about 1,000 meter square. The manufacturing facility is equipped with modern production machineries such as closed type extraction and low temperature vacuum concentration system, spray-drying and fluidized-bed granulation machine, capsule filling and blister machines, etc. To meet GMP requirements our facility has separate material and personnel flow, individual rooms for different operations, and Class100,000 cleanrooms. The Quality Control Laboratory is set up to perform safety, quality and stability test for identification of raw material, testing of intermediates and finished products. Some of our major equipment is listed below for your reference:

Production Equipments

Quality Control Equipments

- 100L Stir-type Extraction and Concentration System

- 100L Basket-type Extraction and Concentration System

- Grinding & Sieving Machine

- Spray Dryer & Fluidized-bed Granulation Machines

- 300L Rocking Mixer

- Automatic Rotary Tablet Press Machine

- Film Coating Machine

- Semi-automatic & Automatic Capsule Filling Machine

- Automatic Blister Packing Machine

- Automatic Counting and Filling Machine

- CMAG TLC System

- Karl Fisher DL38 Water Content Analyzer

- SOTAX DT3 Disintegrator

- Agilent Series 1100 HPLC System with Evaporate Light Scattering Detector

- Agilent Series 1100 LC/MSD Mass Spectrometer

- Agilent Series 6890 Gas Chromatography System

- Forma Scientific Steri-Cult HEPA Filtered IR Incubator

Table 1: list of some of the major equipments for production and quality control

(Click here for our facilities' fact sheet)

Our facility has obtained a full manufacturing license from the Department of Health in Hong Kong since 2003 and was inspected by the Therapeutic Goods Administration (TGA) for GMP manufacturing license in October 2004. Approval is currently pending.

The TCM unit is offering service to our clients on a cost-recovery and pay-per-use basis in the areas of contract manufacturing, product development, consultation, GMP implementation, product registration (Hong Kong only) and GMP training.

Bio-analytical Testing Service

Our team has extensive experience in the analytical testing methods that are listed in the Pharmacopoeia of the Peoples’ Republic of China 2000. Combined with our in-house laboratory equipment and facility and the research expertise of scientists from the Chinese University of Hong Kong School of Chinese Medicine, we are offering testing service on the following areas:

- Identification of Chinese herbal material against standard (see Tables 2 and 3);

- Chemical composition analysis of Chinese herbal material from client;

- Quality testing for healthcare products from client;

Herbal Material

Reference Material

Cordyceps powder from fermentation

Ganoderma

Radix astragali

Radix platycodonis

Powder of Radix panacis quinquefolii

Fructus crataegi

Fructus lycii

Radix salviae miltiorrhizae

Semen ziziphi spinosae

Radix puerariae

Radix ginseng

Radix glycyrrhizae

Pericarpium citri reticulatae

Extract of Radix et rhizoma rhodialae

Extract of Gynostemma herba

Fructus liyustri lucidi

Fructus schisandrae sphenantherae

Green tea extract

Coriolus versicolor

Adenosine

Reference herbal material

Astragaloside

Reference herbal material

Ginsenoside Rb1

Ursolic acid

Reference herbal material

Tanshinone I, Tanshinone IIA

Jujuboside A, B

Puerarin

Ginsenosides Rg1, Re

Glycyrrhizin, Glycyrrhizic acid

Hesperidin

Salidroside

Ginsenoside Rb₁

Oleanolic acid

Schisandrin

Catechin

Reference herbal material

Table 2: reference standards for identification of different herbal materials

Active Component

Analytical Method

Ginsenoside

Adenosine

Ferulic acid

D-mannitol

Astragaloside

Total Polysaccharide

Oleanolic acid

Ergosterol

Puerarin

Daidzin

Hesperidin

Glycyrrhizin

Glycyrrhizic acid

Salidroside

Lithospermic acid

Tanshinone I

Tanshinone IIA

Crypto tanshinone

Schisandrin

HPLC

Photospectrometric assay

HPLC

Table 3: analytical methods for identification of different active component in herbal materials.

Contract Process Development & Manufacturing

Process development is highly dependent on user requirements and specification for the final product and its function. Usually the process starts from evaluation of extraction method with either water or ethanol of different concentrations in small laboratory scale. Pilot testing will be conducted using our 100-litre extraction and concentration system. Other parameters we will develop include spray drying method, capsule filling, type and ratio of excipient to be used. We have successfully developed products based on herbal materials such as Ganoderma, Fructus lycii, and Radix et rhizoma rhodialae. Our team is able to help our client in selecting the correct process through this knowledge-intensive and time-consuming step.

Our production facility is open to industry members wanting their products to be manufactured under internationally recognized GMP guidelines. We have used our facility to produce Chinese medicine-based products for years. For those large-scale production projects, we are able to, upon client’s request, provide raw herbal material as a starting point. We may on the other prefer material to be provided by client in case those projects are of small-scale and short-term in nature. Our in-house production technology and production capacity are highlighted below:

Herbal Material: either provided by client or to be sourced by HKIB

Extraction Method: water-based or alcohol-based extraction

Separation Method: precipitation

Drying Method: spray-drying

Dosage Form and Production Capacity (per day):

60,000 – 80,000 gelatin capsules (semi-automatic machine)

120,000 – 140,000 gelatin capsules (automatic machine)

300,000 – 600,000 tablets

5,000 – 10,000 sachets

Contract Product Evaluation Service

For a product to be marketed in Hong Kong, it has to be evaluated against toxicity (both long-term and acute), microbial and pesticide residue contamination before it can be applied for product registration with the Department of Health. We have a good working relationship with the appointed municipal Institutes for Drug Control in mainland China and are able to coordinate the safety evaluation and testing of your product. Hence, clients can devote more time in documentation before submission of application to the local authority.

For further evidence-based evaluation on existing Chinese medicine-based product, HKIB can initiate collaborative studies with a number of research units in the Chinese University of Hong Kong, such as the Institute of Chinese Medicine, the Drug Development Centre, the School of Chinese Medicine, the Nethersole School of Nursing and the Lady Pao Children’sCancer Centre, to do sponsored product evaluation on clinical efficacies. Below are some of the project highlights we have carried out before:

- Herbal formulation for the treatment of diabetic foot;

- Dietary supplement Ganoderma lucidum capsule for children with cancer;

- Herbal formulation for child asthma patients.

Product Registration and Related Consultation

Our unit can also assist clients in applying product registration with the Department of Health of the Hong Kong SAR Government. Our team is familiar with the whole product registration process and procedure. We are happy to provide consultation service on various aspects of the registration cycle, including document preparation, and the need of additional requirement for document submission. Clients may also appoint us to do the product registration on their behalf. Our staff will take care all the details and if necessary, work with you to correct the deficiencies of your application.

We would like to help you consider the possibilities. For more information about our service, call us, visit our website, or shoot us an e-www if you have any questions.

Enquiry

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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