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* About Us
* GMP Capabilities
* R&D Services
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  + About Us
  + GMP Capabilities
  + R&D Services
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## Discovery
  Building Blocks Custom synthesis Chemistry R&D Service
## Development
  Route Scouting Process optimization Process Characterization Impurity studies   
## Manufacturing
  RSMs/Intermediates/APIs
 GMP and non-GMP scale up GMP QC release ICH long term stability testing   
## Technologies
  Flow Chemistry Micropacked Bed Hydrogenation Crystallization  Solid State Chemistry  Particle size reduction                         PharmaBlock USA, Your Domestic CDMO Partner.                                           Values       Our Culture
* !     **Equality**
* !     Enterprise
* !      **Innovation**
* !      **Cooperation**
## QUICK LINKS
## SERVICES & SOLUTIONS
## Call Now For Service！
  1-877 878 5226
       Email Us              800 N 5 Points Rd,  West Chester, PA 19380, USA   777 Schwab Rd, Unit D Hatfield, PA 19440,USA                              Copyright 2022 PharmaBlock (USA), Inc. Support By  .
                 **PharmaBlock USA Sites**  You are here:       »   About Us    » PharmaBlock USA Sites                      !   Process R&D and GMP Production PharmaBlock USA-1   **Location:**West Chester, PA
**Functions:**Process R&D and GMP API Production
**Facilities:**4-acre campus; Building space 30,000 ft2Process R&D labs, GMP kilo labsPilot plant (in progress)
**Compliance:** GMP (registered with FDA) and ISO9001
**Address:** 800 North 5 Points Road West Chester, PA, 19380 United States                !   Business Center and R&D LabsPharmaBlock USA-2   **Location:**Hatfield, PA
**Functions:**Sales and logistics, Building Block warehouseChemistry R&D service
**Facilities:**15,000 ft2 of offices, labs and warehouse
Research labs and Kilo labs
**Compliance:**ISO9001
**Address:** 777 Schwab Rd, Unit D Hatfield, PA, 19440 United States               !
West Coast Sales OfficePharmaBlock USA-3   **Location:**Sunnyvale, CA
**Functions:**Sales and Customer Service
**Address:**725 San Aleso Avenue, Suite #8 Sunnyvale, CA 94085 USA
          **GMP System**  You are here:       »   GMP Capabilities    » GMP System                       !                 We are in full compliance with GMP regulations and effectively manage various aspects such as record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.​
 Registered with FDA​
 Our facility has officially notified the U.S. Food and Drug Administration (FDA) of its existence and its activities related to the production, processing, packing, or storage of food, drugs, medical devices, or other regulated products. This registration is a legal requirement, and it provides the FDA with essential information about the facility, which is used for regulatory and inspection purposes. It allows the FDA to monitor and inspect the facility to ensure compliance with regulations and to protect public health and safety. ​
 ISO9001 Certified since 2019 ​
 We have established and maintains robust quality management system, including a strong customer focus, process improvement, documentation of processes and procedures, monitoring and measuring performance, and a commitment to continual improvement. Our commitment is to consistently provide services that meet customer requirements and comply with applicable regulations and standards.​
 Client GMP Audit​
 Our sites have been audited by many clients for whom we have manufactured API, RSM and GMP intermediates.​
 QA Team ​
 Our Quality Assurance (QA) team ensures pharmaceutical products are produced in compliance with strict quality and GMP regulatory standards. Strict adherence to GMP standards and regulations is essential to ensure the safety, efficacy, and quality of pharmaceutical products.            !
## Learn more about PharmaBlock US quality system
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 1-267 649 7271        Email Us              800 N 5 Points Rd,  West Chester, PA 19380, USA   777 Schwab Rd, Unit D Hatfield, PA 19440,USA                              Copyright 2022 PharmaBlock (USA), Inc. Support By  .
          **GMP Case study**  You are here:       »   GMP Capabilities    » GMP Case study                     API Client Testimonials
* The facility is clean and organized well. The team is composed of experienced process chemists, QC and QA. They made my client’s delivery in a timely manner with very good quality. Definitely recommend to those who are searching for US-based early development stage GMP API facility.--- Biotech Client
                !     **PBUSA GMP Projects Examples** **GMP API for Phase I study​**
—Total 4 GMP steps, SM staged in PharmaBlock Nanjing, 2 GMP steps each in China and US to meet tight timeline.​
—GMP production in China ongoing, GMP production in US target to complete by end of Sep 2023.​
—3-year ICH stability study (40°C/75% RH for 6 months and 25°C/60% RH for 36 months) from Oct. ​
**GMP Intermediate/RSM​**
—Optimized 4 steps synthesis, scaled up first 3 non-GMP steps in PB China, final step GMP synthesis in US (2 kg)​.
—Analytical method development, validation and COA release.                      !     !     !     !     !     !     !     !     !               
          **Solid State Chemistry Services**  You are here:       »   R&D Services    » Solid State Chemistry Services                   **Solid State Chemistry Services**            Solid State Chemistry Services
* — Polymorph Screening ​
  — Solubility measurement and solubility temperature curve ​
  — Solid state characterization​
  — ​​​​​​Particle size reduction and analysis
        !                     **Equipment**
* XRPD, Rigaku​
* Crystal 16, Technobis​
* Particle Size Analyzer ​
* DSC, TGA​
* Sonicator, Cole Parmer​
* Refrigerated centrifuge
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          **Old\_Chemistry Capabilities**  You are here:       » Old\_Chemistry Capabilities                   **Chemistry Capabilities**            Synthetic Capabilities
* — Precise route selection & phase-appropriate process and analytical development
* — Process development, optimization and rapid scale-up of building blocks, key intermediates, RSMs and APIs.
* — Expertise in DoE, Quality by Design (QbD) approach
* — Impurity profile, fate and purge studies
* — Critical process parameters (CPP) and critical quality attributes (CQA) evaluation
* — Reaction modeling/simulation, DFT calculations
* — Continuous flow and enzymatic chemistry capabilities
* — Early phase toxicology batches, GLP tox batches
* — Phase I and II clinical batches (cGMP)
        !                 Solid State Capabilities   — Solubility measurement and solubility temperature curve— Polymorph Screening
— Salt screen and selection— Solid state characterization
* — Crystallization process development and polymorph control
* — Particle size reduction and analysis
        !                Analytical/QC Capabilities   — Analytical Method Development/Validation/transfer
—​​​​​​​GMP release testing
—​​​​​​​Residual Solvents testing
—​​​​​​​Compendial Method Verification/Testing
—​​​​​​​Impurity isolation and identification by Prep-LC,LC/MS, LC/MS/MS, NMR
—​​​​​​​Stability Chambers
    · ICH stability storage and testing (25°C/60% RH; 30°C/65% RH;      40°C/75% RH; 2-8 °C)
   · Photostability study
   · 24/7 alarms: email/online system        !                                 !     !     !     !     !     !     !     !     !     !     !     !                      