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COMPANY DETAILS » Next Century Incorporated back to previous page show list

Next Century Incorporated

»
address: Headquarters:
Next Century Inc.
Delaware Technology Park
1 Innovation Way, Suite 100
Newark, DE 19711, USA
Tel: 302.453.0570
Fax: 302.453.057
contact: Representative Office
Next Century Shanghai Office
Yujia Building 16th Floor, 1336, Room F
Huashan Rd.
Shanghai, 200031, P.R. China
Tel: 8621.6240.5921
Fax: 8621.6251.8600
key person: E. Marshall Johnson, Ph.D. - Advisor & Board Director

Mark Hite, ScD., DABT. - Board Director & Sr. Director for Scientific & Regulatory Affairs

Cynthia H. Stahl, Ph.D. - Board Director

Glenn McAlli

trunover in millions USD: 0
R & D turnover in millions USD: 0
NET profit: 0
year of financial results:
employees: 0

active in China: YES

SFDA approved: NO

Approvals:
GLP: NO
GMP: NO
AAALAC: YES
SEPA: NO

Activities engaged in:
Manufacture: NO
Active Pharmaceutical: NO
R&D: NO
Ingredients: NO
Western Generics: NO
TCM: NO

R & D:
Discovery: NO
Work Up (pilot to production): NO
Analysis: NO
Quality Control: NO
Stability: NO
Batch Release: NO

Clinical trials:
Run/Manage: NO
Data management: NO
Support Labs: NO

Non clinical & preclinical:
Animal Testing: GLP: YES
New materials Safety Assessment: YES
Pharmaceuticals: YES
Agrochemicals: NO
Industrial & Other Chemicals: NO
Non GLP - Discovery ADME: YES

Chemistry-contract manufacture:
Generics: NO
API: NO
Licensed Drugs: NO

test:
R&D: NO
 

Next Century Incorporated (Next Century) is a service-oriented independent CRO that offers preclinical safety assessment to, the pharmaceutical, chemical, biotechnology and other industries. During the years, Next Century has established its reputation for outstanding quality, on-time delivery, and excellent client services.

 
Established in the United States in 1994, Next Century is a Delaware Corporation located in the Delaware Technology Park. The headquarters is an ultra-modern facility, which includes corporate offices, well-equipped labs for genotoxicity tests and assay development, a Quality Assurance Unit and an Archive Room.


Next Century has two subsidiary labs and a representative office in China. The labs, located in Nanjing and Guangzhou, are GLP-compliant and are used to conduct general toxicology studies on a variety of species, including rodents, non-rodents and non-human primates. By conducting some of the preclinical studies in our subsidiary labs, we can substantially cut R&D costs and pass the savings on to our clients, while maintaining the highest quality necessary to meet or exceed U.S. and other regulatory agencies' requirements. We offer same quality at different cost to meet your needs.

Next Century's goal is to enhance your product development plans and regulatory goals by providing the most cost-effective services. All studies at Next Century are designed and conducted in a timely manner to allow our clients to meet their development plan, and international regulations and requirements. At Next Century, high quality and on-time delivery is always the result of our sincere effort, intelligent direction, and skillful execution.
 
Next Century Nanjing Lab

 

Next Century's Nanjing subsidiary lab includes an animal barrier system area located in Building 1 of the Nanjing Medical University's Wutai campus. The 6,889 sq ft barrier system is used for rats and mice at clean and SPF levels. The facility has a ventilation system, an air-conditioning system, and a monitoring system for humidity and air-pressure. The purification degree is 10,000 .Non-study related personnel do not have access to the area and a sign-in log is used to control access. Experiment monitoring system is available in the barrier system.

The 12,917 sq ft functional laboratory is equipped with an air-conditioning system. The purification degree is at ordinary level. Non-study related personnel are not allowed to access the facility without authorization. 
The test article storage room and archive room are both equipped with a ventilation system and an air-conditioning system. A recognition system is used to identify test article number. Access to the archive room is limited to authorized personnel. 

Their subsidiary's non-SPF animal area is located in the Animal Laboratory Center of the Nanjing Medical University's Wutai campus. The 3,767 sq ft lab is used for experiments with rats and mice at clean level and for guinea pigs and rabbits at non-SPF level. The facility is equipped with a ventilation system and an air-conditioning system and the purification degree is at ordinary level. Security guards are on duty 24/7 and nobody is allowed to access the facility without authorization.

The non-rodent animal facility, located at the SuZhou Animal Study and Research Center on Lake Tai XiShan island in JiangSu province, is a major facility for non-rodent animal breeding and research. The facility has a collaborative relationship with the Nanjing Medical University's Center of Safety Assessment and Research for Food, Drugs, and Pesticides, and serves as the center's non-rodent animal facility. The facility has a 43,056 sq ft comprehensive laboratory building equipped with a ventilation system and an air-conditioning system, as well as a long-distance monitoring system used to monitor experiments with dogs, monkeys and mini-pigs. The facility also has an area for non-rodent animal breeding, which guarantees animal supplies. A security alarm system is in place and nobody is allowed to access the facility without authorization. Although there is no designated space for Next Century in the facility, we are given priority to use the facility for our studies.
 
Guangzhou Lab

Next Century's Guangzhou lab is located in the Guangdong Prevention and Treatment Center for Occupational Diseases, which was founded in 1960. The Center is an authorized, 4-phase toxicological testing laboratory for pesticides, accredited by the Ministry of Health and the Ministry of Agriculture of China. The Center has also been rated a First-Grade laboratory on toxicity identification for chemicals by the Ministry of Health of China. Of the Center's 230 employees, 13 of them work in the Department of Toxicology and, among them, seven are senior researchers.

The Department of Toxicology has completed many toxicological research projects. The department's well established Quality Control system was assessed by the Chinese National Accreditation Board for Laboratories (CNAL) and was proven to be in compliance with CNAL/AC01: 2002 Accreditation Criteria for Testing and Calibration Laboratories (identical to ISO/IEC17025: 1999 General Requirements for the competence of Testing Calibration Laboratories).

The Department of Toxicology occupies an area of 17,222 sq ft, including labs for animals (8,073 sq ft), embryonic stem cells, cells, bacteria, pathology, microscopic and image analysis, molecular biology, and genetic toxicology. The SPF (specific pathogen free) animal lab is currently under construction and will be ready for use by the end of 2005.

The SPF animal lab is being established in compliance with the regulations of the Chinese National Standard Laboratory animal equirements of environment and housing facilities (GB 14925-2001). The facility will have adequate ventilation, an air-conditioning system, as well as a monitoring system for temperature, humidity and air-pressure. The air clean degree is 10,000. No unrelated personnel will be allowed access to the lab and a sign-in log will be used to control access. Experiment monitoring system will be used in the barrier system and experiment waste will be properly treated or removed by licensed companies.

A 2,691 sq ft cleaned animal lab that includes a 1,507 sq ft barrier system is located on the ground floor of the building that houses the library. This lab is currently being used for SPF rats and SPF mice.

A 4,306 sq ft regular animal lab is housed on the 11th floor of the Research Building. In this lab, testing is conducted on ordinary rabbits and guinea pigs, SPF rats and SPF mice, and the lab is under network monitoring.

On the 10th floor of the Research Building is a 7,212 sq ft functional laboratory. This lab is used for embryonic stem cells, cells, bacteria, pathology, microscopic and image analysis, molecular biology, and genetic toxicology.

 

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