Porton J-STAR
Solving Complex Chemistry Problems with Creative Solutions for 30+ Years
3001 Hadley Road, Suites 1-5A, South Plainfield, NJ 07080, USA
6 Cedarbrook Dr, Cranbury Township, NJ 08512, USA
30+Years
Founded in 1996, J-STAR Research, Inc. is a contract chemistry R&D organization serving as an outsourcing partner for the pharmaceutical and biotechnology industry.
12,000m2Area
We have steadily added, and continues to expand, in the areas of Process Chemistry, Analytical R&D, QC/QA, GMP delivery, Crystallization R&D, Solid States Screening, Catalysis Screening, Enabling Technologies, High Potent Compound Handling (HPAPI), Impurity Isolation and Structural Elucidation, Pre-formulation, Formulation R&D and Oral Solid Drug Product GMP manufacturing.
60%Doctor Degree
Porton J-STAR has assembled a team of chemists, scientists and engineers committed to creatively solving complex and matrixed chemistry problems. The emphasis of this support is focused on chemistry-related problem solving centered on Active Pharmaceutical Ingredients and Intermediates in the preclinical and clinical development arena.
Facilities
J-STAR South Plainfield R&D Site
J-STAR Cranbury R&D Site
J-STAR South Plainfield R&D Site
- 34 Fume Hoods in Seven Laboratories
- 2 GMP Kilo Labs with ChemGlass Reactors – up to 100L
- 2 Analytical Suites for On-Site Method Development and Release Testing
- Hydrogenation Room – up to 20L Capacity at 1500 psi
- 2 High Field NMRs On-Site (400 MHz and 300 MHz)
- Multiple HPLC + GC + LC/MS Instruments for Routine Walk-Up Access
- Catalysis & Enabling Technology Hub
- Scheduled Compound (II-IV) Handling
J-STAR Cranbury R&D Site
- 34 Fume Hoods in multiple laboratories
- 4 Walk in Kilo lab Walk-in Hoods with up to 100 L Vessel Processing
- 1 High Potency Compound Handling Suite with 2 Isolators: cGMP Compliant in 2018
- 1 Analytical Suite for On-Site Method Development and Release Testing
- 1 Quality Control Suite for Release Testing
- 2 High Field NMRs on Site (500 MHz with Cryo probe and 400 MHz)
- Multiple HPLC + GC + LC/MS Instruments for Routine Walk-Up Access
- Crystallization R&D
- Preformulation and Formulation
- High Resolution Orbitrap UPLC-MS
- Structural Elucidation Hub
Services
Drug Substance
High Potent API & Potent Compounds
Drug Product R&D and GMP Manufacturing
Crystallization & Material Science
Analytical R&D and QC
Drug Substance
Porton offers efficient, flexible, and high-quality solutions for custom development and production of small molecule APIs, as well as technical services throughout the entire lifecycle from pre-clinical to commercial to our worldwide partners.
- Route Scouting/Design, Early and Late Phase process R&D; GMP Delivery
- Impurity Isolation Synthesis
- HPAPI, ADC Linker and Payload
- Catalysis & Flow Chemistry Technologies
High Potent API & Potent Compounds
Optimized HPAPIs, ADCs and potent compounds development and manufacturing (non-GMP and cGMP) tailored to your specific needs in our new 3000 sq facility equipped with Glovebox Workstations (Isolators) capable of less than 30 ng/m containment.
1)GMP Facilities:
- OEB 5 (<1 μg/m³)
- Bench & Walk-In Hoods
- Up to 100 L Vessels
- Prep HPLC and Lyophilizer
- Mobile Gloveboxes
- Flexible Single-Use-Systems for Powder Handling
2)non-GMP Facilities:
- OEB 5 (<1 μg/m³)
- Extract-Walker Barrier Isolators: 2
- HPAPI Linear Glove Box Feet: 2*8
Drug Product R&D and GMP Manufacturing
At our state-of-art R&D laboratory and expansive 5,100 sq ft GMP facility, we provide tailored drug product development services designed to fast-track the advancement of your Phase I and II drug products.
- Comprehensive Formulation Development
- Clinical Trial Material Manufacturing
- Enabling Formulation Technologies
- Solubility Enhancement and Bioavailability Optimization
- DS-DP Co-processing
Crystallization & Material Science
We offer fast, effective, phase appropriate and first-time right solutions which are based on scientific understanding to challenges in solid form and crystallization process by utilizing our technical expertise and extensive experience in the industry.
- Crystallization Process Development
- Particle Engineering
- Solid Form Screen/Selection/Studies
- Pre-formulation Evaluation
Analytical R&D and QC
We provide Analytical development and QC expertise at all stages of DS and DP development. With tailored workflows, advanced instrumentation, and a team of expert scientists, we deliver actionable insights that enhance product quality, reduce development timelines, and ensure regulatory compliance.
- Analytical Development and QC
- Method Validation
- Stability Study
- Structural Elucidation
One Porton One Quality
Compliance standards, Continuous improvement, Customer oriented
Quality management runs throughout the entire process of the drug life cycle. The quality management system of the drug product site is built in accordance with international standards and continues to adhere to the quality concept of 'more well-established system, more controllable quality.' This ensures that the GMP activities of the drug product site meet the requirements of international quality management systems and market drug regulatory agencies, including those of China, the European Union, FDA, and other mainstream regulations.
Case Studies
Preformulation Strategy- Inception to Completion
Facilitating PROTAC Drugs Development with Innovative Processes
Efficacy and Safety - Guidelines for Clinical In-use Stability Studies of ADCs
Continuous Improvement of Project Life Cycle Management, Benefiting Customers by Reducing Total Cost
Molecular Modeling and Data Science for De-risking and Cost- saving of Pharmaceutical Development
Agile and Fast：Enabling Rapid Market Launch of Innovative Drugs from Preclinical to Commercialization in 18 Months
Overview and Case Study of Antibody Oligonucleotide Conjugates (AOC)
Co-processing: Co-Precipitation Technology (CPT) for the Enhancement of Flowability and Bulk Density
An ADC's Path to Market-Analysis of Difficulties and Key Points in ADC Process Scale up
ENT-03 GRC Poster
Co-processing Series: 4. Heterogeneous nucleation (HN)
Co-processing Series: 3. Adsorption
