Specialized Enterprise · Postdoctoral Research StationSpecialized Enterprise

Integrated CRDMO Services

With both custom R&D and scale-up manufacturing capabilities, we provide pharmaceutical companies with services from process development and scale-up to registration batches and commercial manufacturing, helping reduce costs, control risks and accelerate launch.

01 CDMO / CMO

Peptide Contract Manufacturing

As a pharmaceutical CDMO, Guangdong Taiyuan Technology Group offers both custom R&D and manufacturing capabilities, covering peptide process development, preparation, optimization, scale-up, registration and validation batches, and commercial manufacturing.

SERVICE SCOPESix Service Areas

  • Manufacturing peptide APIs for clinical trial and commercial batches
  • Providing GMP clinical trial material and commercial manufacturing services
  • Packaging and labeling for clinical trial materials under GMP requirements
  • Providing a platform for process research, parameter exploration and registration process definition
  • Quality standard research, analytical method validation and ICH-compliant stability studies
  • Supporting MAH implementation for peptide drug marketing authorization holders
Integrated CRDMO services
GMP CAPACITY

4 GMP API Workshops

Four GMP API workshops are in operation and ten additional GMP workshops are planned, supporting commercial supply at different scales.

02 PROJECT FLOW

Two Business Paths, Four-step Delivery

I. New Drug

Preclinical Research

Route design, lab-scale trials and process parameter exploration

Clinical Sample Manufacturing

GMP clinical trial material manufacturing, packaging and labeling

Clinical and Registration Support

Quality standard research, method validation and registration dossier support

Commercial Supply After Launch

Stable scale-up supply and continuous process optimization

II. Generic Drug

Pre-pilot Batch

Reference product comparison and critical quality attribute research

Three Pilot Batches

Process scale-up and reproducibility verification

Validation Batches

Registration and process validation batch manufacturing

Commercial Supply After Launch

Commercial batch delivery and technology transfer support

03 CRO

Peptide Pharmaceutical Research Services

Guangdong Taiyuan Technology Group's CRO peptide services include peptide pharmaceutical quality research and peptide project development.

CRO · QUALITY RESEARCHPeptide Pharmaceutical Quality Research

I. Generic Drug Development

  • API critical quality attribute research
  • Reference quality comparison
  • Process research
  • Quality research
  • Stability study and method validation
  • Technology transfer

II. Innovative Drug Development (Preclinical)

  • API process research
  • Formulation process research
  • Quality research

III. Formulation Consistency Evaluation

CRO · PROJECT DEVELOPMENTPeptide Project Development

I. Process Development

  • Lab-scale process
  • Purification process
  • Manufacturing process

II. Method Development

  • API methods
  • Formulation methods

Our peptide products and services support downstream drug R&D and manufacturing across pharmaceutical studies, clinical trials, registration and future commercial production.

04 GMP CAPACITY

GMP Capacity and Compliance Assurance

Workshop CapacityWORKSHOP
4 GMP API workshops10 GMP workshops plannedAnnual peptide powder capacity: 8,000 kgAnnual peptide solution capacity: 2,000 t
Compliance SystemCOMPLIANCE
US FDA CertifiedICH Stability StudyGMP for Clinical Trial MaterialsISO SystemsMAH Implementation Support
ClientsCLIENTS
China Resources Double-CraneSimcere PharmaceuticalMore domestic and international innovative pharmaceutical companies

Need Contract Manufacturing or
Pharmaceutical Research?

Please provide target product, development stage and expected timeline. Our project team will match the appropriate process and capacity plan.

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