Pre-Clinical & Clinical Development and Manufacturing Services
Connected drug substance and drug product services that support programs from early development through GMP manufacturing and clinical supply.
BioDuro brings drug substance and drug product development together within one CMC organization. Our capabilities include process chemistry, API manufacturing, pre-formulation, formulation development, analytical support, and GMP clinical manufacturing. By keeping these activities closely connected, we help clients reduce handoffs, manage development risk, and prepare for IND, clinical, and commercial milestones.
Supporting Efficient CMC Progression from Development to Clinical Manufacturing
CMC programs move more smoothly when drug substance and drug product teams work together early. BioDuro connects process chemistry, formulation, analytical, DMPK, and manufacturing teams within a coordinated development plan. This helps sponsors address API properties, formulation performance, scale-up, and regulatory requirements as the program advances.
Our capabilities span process R&D, API manufacturing, pre-formulation, formulation development, analytical method development, stability support, and GMP clinical supply. When useful, formulation screening can also be paired with in vivo PK evaluation to help select the best path forward based on both laboratory performance and drug exposure.
Facilities in Shanghai, Bengbu, Jiangsu, and Taiwan support development, scale-up, clinical supply, and commercial API manufacturing.
Drug Substance Development & Manufacturing
BioDuro supports drug substance programs from route scouting and process development through GMP API manufacturing and commercial production. Our teams focus on developing practical, scalable processes, controlling impurities, and maintaining reliable supply as programs move from early development into the clinic and beyond.
Capabilities include:
- Process R&D and route optimization
- Process safety assessment
- Preparative purification
- Kilo lab and pilot-scale production
- RSM and intermediates
- GMP API manufacturing
- Flow, sugar, and peptide chemistry
- Commercial API manufacturing
Backed by manufacturing infrastructure across Shanghai, Bengbu, and Taiwan.
Drug Product Development & Clinical Manufacturing
BioDuro supports drug product programs from pre-formulation and developability assessment through formulation development, process scale-up, and GMP clinical manufacturing. Our scientists use a fit-for-purpose approach, selecting the formulation strategy around the compound, route of administration, dose, release profile, stability, and manufacturing needs.
Capabilities include:
- Physicochemical profiling and solid-form selection
- Solubility and bioavailability enhancement
- Amorphous solid dispersions, spray drying, and hot melt extrusion
- Particle engineering and lipid-based formulations
- Immediate- and modified-release technologies
- Oral, injectable, ophthalmic, topical, and nano-formulation development
- Oral peptide delivery
- Analytical development, stability testing, and regulatory support
- GMP clinical manufacturing for oral solid and topical dosage forms
These capabilities include tablets, capsules, granules, oral liquids, injectable and lyophilized formulations, eye drops, creams, ointments, gels, lotions, and nano-formulations.
Our formulation capabilities cover more than 95% of marketed dosage forms. BioDuro has also supported the manufacture of hundreds of clinical trial batches for global markets, with operations designed to meet applicable GMP requirements in the United States, European Union, and China.
For suitable programs, BioDuro offers an accelerated 8–12-week path to an IND-ready formulation, covering pre-formulation, formulation and process development, analytical method development, preliminary stability, demo-batch preparation, and finished-product testing.
Services overview
