1:Protein Drugs Development Program The
Program is at a leading edge in the industry for its research and
development capability as demonstrated by two Investigational New
Drugs, namely IFNα-Fc protein therapeutics and nasal influenza vaccine
(patent pending). Another leading project is development of monoclonal
antibodies against HCMV and IL-20. Other leading projects include
development of bispecific antibodies and application of LT mucosal
adjuvant in vaccines. In addition, the Program will provide contract
laboratory services in compliance with international stands to meet
emerging industry demand. 2: Pharmaceutical R&D Program Pharmaceutical
R & D program conducts research in chemistry, formulation,and
pharmacology for drug development. In order to meet our government
policy in the biotechnology industry, the core facilities for
preclinical tests including pharmacology laboratories, kilo chemical
manufacturing lab and cGMP formulation pilot plant have been
established. Pharmacology Laboratories offer services for testing
various types of products, including new chemical entity, Chinese
herbal medicines, biopharmaceuticals, health food, food additives, agro
chemicals and cosmetic products. Our customers include local and
international pharmaceutical and biotech companies, the academic
organizations and the governmental agencies.
Biololgy &
pharmacology group, located at the Hsi-Chih campus, is consisted of 17
staff and has enzyme chemistry, tissue cell culture, and animal study
laboratories. Research activities include in vitro or in vivo screening
of small molecules that target cancer or diabetes, e.g., enzyme
kinetic, cytotoxicity, flowcytometery analysis, and cancer animal
studies.
The hardware space of Pharmaceutical R&D Program is
comprised by chemistry laboratories, formulation laboratories, a GLP
kilo-scale chemical manufacturing laboratory and cGMP formulation pilot
plant, occupies 1,738 square meters of laboratory space. With 39
scientists, we offer bulk drug synthesis, formulation design, process
development as well as production of preclinical and clinical drug
candidates. The department of health has granted an operation license
for the cGMP formulation pilot plant on September 17, 2002 and has
approved this pilot plant complied 4th stage cGMP validation on. About
40 research papers have been published and 10 worldwide patents have
been issued to this program in the last five years
Achievements of Pharmaceutical R&D Program
Evaluation
of lead molecules and new drug development: (1) development of
selenophene-based anti-cancer agents – The lead molecule D-501036
showed high efficacy in vivo; in the first liver cancer xenograft
animal model (Hep-3B), about 60 % inhibition was observed, and in the
second liver cancer xenograft animal model (HuH-7), more than 90 %
inhibition was observed. D-501036 also showed strong inhibition in the
renal A-498 and lung NCI-H226 xenograft tumor models, more than 99 %
and 60 % were observed respectively in the models. In these evaluation
experiments, less than 15 % body weigh variation each was observed
during the dosing period, which revealed strong tolerability.
Currently, we are actively in promoting this project to domestic
pharmaceutical companies; (2) we have established various assay systems
and achieved several important mechanistic studies, including
topoisomerase I enzyme assay, tyrosine kinase inhibition assays (EGFr,
VEGFr, PDGFr, FGFr), cell apopotosis studies and cell life cycle
studies, these assay systems and mechanistic studies can be employed in
current anti-cancer drug discovery; and (3) we have established 8 human
cancer skit mice animal models, including liver cancer, lung cancer and
renal cancer, etc., which can be employed in pre-clinical anti-cancer
drug development.
New dosage form development is to establish the
inhaled pulmonary drug delivery platform technology. This includes:
micronization technology, metered dose inhaled pulmonary drug delivery
technology, and lung absorption animal model. Collaboration with
industry is an essential part of our research activities. In 2004
transferred adrenoreceptor pulmonary drug delivery product to Advanced
International Pharmaceutical Nanotech, Inc., and completed albuterol
sulfate HFA MDI scale-up production. In 2003 initiated to explore
insulin inhalation product successful together with industry partner
joining from Purzer Pharmaceutical Co., and Chi Seng Chemical Co. In
2005 developed a process for manufacturing insulin inhalation in
laboratory scale, transferred technology to the cooperative companies,
developed the production scale in cGMP facility, evaluated the PK of
insulin inhalation product in animal. In 2006 helped to organize MDI
dosage form products R&D alliance, comprised by Synmosa Biopharma
Co. and PharmaEssentia Co., has been granted by MOEA. In 2006 another
new dosage form research is focused on sustained-release injectable
dosage formulation development for goserelin acetate, this established
platform technologies including the biodegradable polymer encapsulating
drug system, manufacturing process, and animal monitoring PK/PD model,
can be applied to the development small molecule, protein, and peptide
sustained-release injectable dosage. Through a technology transfer to
the domestic pharmaceutical companies, we will be able promote and
upgrade their capability in related products technology and provide
patients a more convenient choice. In 2007 cGMP formulation pilot plant
has been approved to comply 4th stage cGMP validation by DOH.
Some
of the technologies have been transferred successfully to local
pharmaceutical companies including Everlight Chemical Industrial Co.,
China Chemical Synthesis Industrial Co,. Ltd., Purzer Pharmaceutical
Co., Ltd., Standard. & Pharm. Co., Ltd. for commercialization. The
drugs such as Fluconazole (bulk), Calcitonin (injectable), Vasopressin
(injectable), Calcitonin (nasal spray), Misoprostol (tablet) have been
marketed. The process development of Fluconazole has been improved and
the US/Taiwan patent on process of Fluconazole (Bulk) has obtained. We
have licensed out to a Indian company to use this patent in the US.
In
the last five years (2003~2007), 40 research papers are published, 10
worldwide patents are issued and 3 technology transfer (licensing fees:
15,534,000 NTD; royalties: 2,166,000 NTD), and 23 investment
(252,566,000 NT) are signed. We offer pharmacology services for testing
various types of products. Our customers include local and
international companies, the academic organizations and the
governmental agencies 3: Herbal Medicine The
goal of this DCB program is to establish core technologies for new drug
discovery and development and to develop Chinese herbal medicine for
cancer adjunctive chemotherapy and for diabetic complication treatment.
These treatments include efficacy enhancement and side effect reduction
and anti-cachexia treatment for cancer adjunctive chemotherapy. 4: Environmental Biotechnology Program The
Environmental Biotechnology Program takes a multidisciplinary approach
to deal with environmental problems. We have assembled a team of
chemists, molecular biologists, biotechnologists, microbiologists,
toxicologists, chemical engineers and environmental engineers to
concentrate our efforts in the following areas: (1) green processes and products; (2) environmental monitoring and contamination detection; (3) clean-up and waste treatment; and (4) resource recovery and reutilization. We
also provide services for the assessment, monitor and remediation of
pollution sites and the treatment of industrial effluents.In
essence, the Environmental Biotechnology Program, which is established
on practical perspectives and pioneering technologies, is dedicated to
meeting the needs of the industry by providing professional services.
Based on the “white biotechnology”, the program aims to promote
“sustainability” through the conservation of water, energy and raw
material, the optimization of industrial processes, and the
minimization of damages to the environment and society. 5: Innovation&Advance Research Innovation
is the key to the success of biotechnology. Thus, DCB initiated a
program, called the Innovation & Advance Research Program (IARP) in
2005. The aims of the IARP are to create platform technologies, to
develop novel products, or to install critical service capabilities.
IARP focuses on the development of novel small molecule drug, and
protein drug. An IARP project typically has one of following
characteristics:
‧ Its idea or concept should have great commercial potential.
‧ Or its products either target a niche market or offer some major improvement compared to existing ones.
‧ Or it has the potential to become an industrial champion. Achievements Expected
‧ To obtain Intellectual Property Right (IPR) with great economical impacts, i.e., key patents.
‧ To realize a breakthrough concept so that it can be further developed into a novel technology.
‧ To encourage interdisciplinary collaboration. |
