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Startups

Main Industry
Biotechnology
Main Product/Service
[Customized Services] null provides customized drug research and development (R&D) and manufacturing services, covering process development, analytical method development, and cGMP manufacturing services for preclinical, clinical, and post-marketing stages of new drugs, as well as generic active pharmaceutical ingredients (APIs) and intermediates. The scope of services includes process development, process scale-up and validation, analytical method development and validation, intermediate and API manufacturing, stability testing, and assistance with relevant regulatory filings.

[Research and Process Development] null possesses strong advantages in chemical synthesis technology and expertise. Within the company, the Process Technology Service Department and the Analytical Technology Service Department work seamlessly together to produce Process Development Reports (PDRs). These reports detail the work and conclusions regarding synthetic routes, processes, experimental results, relevant analytical data, and cGMP-related activities during the development period. PDRs provide a scientific basis for continuous improvement and change control in regulatory registration and filings for preclinical stages, clinical trial entry, and commercial mass production.

[Analytical Services] In addition, null also provides analytical services, such as analytical method research, development, and quality control; reference standard identification and characterization; cGMP process control; testing and release of intermediates and finished products; and regulatory-compliant stability testing services.

[Manufacturing] Lastly, null also provides manufacturing services, including real-time cGMP development, manufacturing, and the production of high-quality products.
(The content above was translated by AI.)
Founded Year
2015
Unified Business No.
24908572
Status
Active
Number of Employees
0
Total Paid-in Capital
574,760,350 (NT$)
Location of Company
Taiwan , Tainan City
Information such as company name, company status, responsible person, year of establishment, paid-in capital, and registered address is sourced from the Commercial and Industrial Registration Office of the Ministry of Economic Affairs; listing status includes emerging stock, M&A, and IPO; overseas development is provided by the startup itself. Notice: This data is compiled from public sources for reference only. We have no direct affiliation with the company and are not their contact person.
About the Company
Grand Summit Biopharma was founded in 2015 and is an international contract development and manufacturing organization (CDMO) company. The Grand Summit team possesses more than 20 years of experience in drug development and manufacturing, providing one-stop services with development flexibility and adjustable process scales. Product types include antibody-drug conjugates (ADC), small molecules, peptides (peptide), and oligonucleotides (oligonucleotide) paired with lipid nanoparticle (Lipid Nanoparticle, LNP) carriers, which can meet and assist clients in achieving their expectations and goals at various stages from preclinical to commercial mass production. As of August 31, 2023, we have provided our global partners with more than 93 products.
(The content above was translated by AI.)



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