CROs/R&D Service Providers At New Jersey Bioscience Center
NJBC residents providing R&D Support Services:
Ascendia – Dr. Jim Huang, CEO and Robert Bloder, CBO
- Providing sterile and non-sterile formulations with analytical, and manufacturing services for biopharmaceutical companies; working collaboratively to provide innovative solutions to challenging drug delivery problems:
- FORMULATION DEVELOPMENT EXPERTS (providing solutions for solubility, bioavailability and/or stability)
- MANUFACTURING (clinical trial materials for TOX, FIH & commercial supply)
- LIFE-CYCLE MANAGEMENT
- 505(b)(2) PRODUCT DEVELOPMENT
Contact
Jhuang@ascendia.com
954-445-1362 or 732-640-0058
Bionex Pharma – Dr. Hock Tan, CEO
- Provides the following specialty lab R&D services:
- Phase I Clinical Trials Materials as well as early Phase II clinical supplies manufacturing
- Formulation development
- In Vitro Permeation Studies
- Extended Formulation Development To: Enhance transdermal flux, Determine chemical stability, Optimize patch properties- adhesion properties, skin adhesion, patch wear study
- IND Filing Support
- Drug Delivery Technologies: Transdermal, Transmucosal, Nasal, Implants etc.
- Analytical Chemistry support, including method development and validation, drug product stability study programs etc.
Contact
hocktan@bionexpharma.com
(732)309-2419
Celleqore LLC– Nicholas Collette, CEO
- Provides the following specialty lab R&D services:
- Full spectrum high parameter flow cytometry analyzing diverse cellular systems
- Multicolor flow cytometry panel design to evaluate effects of small molecules, antibodies, gene therapy, and cell therapy for preclinical and clinical studies
- Flow cytometry functional assays: phosphorylation signaling events, proliferation, receptor-ligand binding events, apoptosis, and many others
- Cell sorting, isolation, and purification strategies
- In vitro and ex vivo models for immunotherapies, tumor-targeted therapies, and combination therapies
- Molecular biological assays and immunoassays
- GXP laboratory and manufacturing validations, FDA/EU/ICH compliance solutions
- Single cell multiomics evaluation
Contact
nicholas.collette@celleqore.com
908-573-6357
HistoBridge – Dr. Yonghua Zhu, CEO
- Provide the following specialty in drug discovery and development, and in drug safety evaluation in the aspects of histopathology for pharma and biotech organizations of all sizes:
- Tissue and slide preparation: frozen and/or paraffin embedded tissues
- Routine slide staining and special slide staining
- Immunohistochemistry and immunofluorescence: single, double, or multiplex labels
- Digital pathology and quantitative image analysis
- Histopathological assessment of tissue sections for treatment efficacy or safety signals
- HistoBridge has developed highly reliable staining protocols (10+ special stains, and 70+ IHCs/IFs)
- HistoBridge has skill set and specialty in cardiometabolic disease therapeutic areas
Contact
Yonghua.zhu@histobridge.com
(908) 745-8343
Kamat Pharmatech LLC – Dr. Madhav Kamat, CEO
- Capabilities:
- Formulation and process development of injectable products – Lyophilized, Biologicals, ADCs, Potent compounds, Controlled drugs (CII-CIV), etc
- Formulation and process development of non-sterile solution products – oral solutions/suspensions, buccal/nasal sprays
- Formulation and process development of topical products – Q1/Q2/Q3, Complex Rheometry, Type II and Type IV dissolution, and permeability studies
- Comprehensive lyophilization support – Cycle development, optimization, QbD, and technology transfer for large-scale commercial/exhibit manufacture
- Fully equipped laboratory to perform all the development work on premises – formulations, analytical (HPLC, PSD, FDM, DSC, etc.), lyophilization, topicals, particle reduction, complex injectables (suspensions, emulsions, and microspheres)
- Experience with support for development of numerous marketed products – NDA, BLA, and generics
- Provide in-house comprehensive 1 to 2-days training course in lyophilization
- Laboratory equipment is available for development purposes
Contact
mk@kamatpharma.com
Neoventech LLC– Jeffrey Wu, Ph.D, CEO
- Provides comprehensive services for topical drug and skincare product development:
- Formulation Development: Q1/Q2 sameness formulas and Q3 characterization with advanced techniques (e.g. GC/MS, Rheometer, DSC, Microscopy)In Vitro Studies: IVPT via human cadaver skin and HPLC method development/test for active penetration analysis
- Complete Development Cycle: From concept to scale-up for topical drugs and skincare products (skincare, women’s care, baby care)
- Proprietary Drug Delivery Systems: Enhanced solubility, skin penetration, and sustained release for drugs and cosmetics
- In-Vivo Assessments: Evaluations for skin and hair products, including color, hydration, and irritation
- Regulatory Compliance: GLP/GMP lab for bioequivalence testing and Phase I, IIa clinical samples
Contact
jwu@noeventech.com
