BioDuro-Sundia
11011 Torreyana Road
San Diego, CA 92121
T: (858) 529-6600
E: hello@bioduro-sundia.com
W: http://www.bioduro-sundia.com
LinkedIn: https://www.linkedin.com/company/biodurosundia/

 

BioDuro-Sundia is a global Contract Research, Development, and Manufacturing Organization (CRDMO), partnering with pharmaceutical companies to develop and manufacture lifesaving drug products for millions of patients around the world. Our mission is “to be the TRUSTED partner delivering world-class drug discovery, development and manufacturing services” in order to speed our clients to clinic and market.

Our legacy as a pioneer in amorphous solid dispersion (ASD) development and GMP contract manufacturing services extends more than 25 years for oral solid dosage (OSD) forms. Our enabling technologies can screen poorly soluble new chemical entities (NCE’s) to increase solubility and enhance bioavailability when only 100 mg of API is available. We use a specialized integrated approach to assess formulation options starting with in-silico evaluation followed by in-vitro screening combined with in-vivo PK animal model data. This screening platform, called Solution Engine 2.0, utilizes physical chemistry modeling to screen miscibility coupled with in-vitro solubility evaluation of ASD candidates and two rounds of animal PK data to select the best enabled bioavailable prototype for further scale-up and development in less than 8 to 12 weeks.

In 2023, we will have global operations across 7 cities with staff of over 3,000 employees across discovery, drug substance and drug product. We offer clients turnkey solutions from formulation development through regulatory approval including commercial scale manufacturing under cGMP conditions with FDA inspected equipment. Today, we are poised to unlock next-level growth through expanded commercial manufacturing capabilities and integrated services.

Discovery Services

• Chemistry
• Discovery Biology
• Oncology
• Pharmacology
• DMPK
• Hit Identification
• Lead Optimization
• Candidate Selection

Development Services

• Drug Substance
  -Process R&D & Scale-up Synthesis
  -Integrated CMC & IND Filing

• Drug Product
  -Bioavailability Enhancement
  -Controlled Release
  -Formulation, Process & Analytical Development

Manufacturing Services

• Drug Substance
  -Phase I/II GMP
  -Phase II/III & Commercial Coming Soon
  -RSM & Intermediate Production

• Drug Product
  -Phase I/II/III & Commercial
  -Amorphous Solid Dispersion
  -Tablets, Mini Tablets, Capsules, Pellets, Powders & Topical Creams
  -FDA approved Manufacturing facilities – last inspected in October 2019. Zero 483s.