Pearl River Laboratories
Contract research organization focused on bioconjugated biologics. Provides discovery-through-clinical support including bioconjugation process development, phase-appropriate GMP analytical testing, method development/validation, formulation and stability studies, and technical transfer/coordination with CMOs. Operates a 21 CFR Part 11-compliant analytical laboratory and supports GLP toxicology and regulatory filings.
Industries
Nr. of Employees
small (1-50)
Pearl River Laboratories
Pearl River, New York, United States
Products
Process Development of Conjugated Biologics
Bioconjugation services from Discovery through Process Development and Technical Transfer to a CMO for bioconjugates including ADCs, Vaccine conjugates, and Oligonucleotide conjugates.
Impurities Isolation, Identification and Characterization
Specialized analytical services focused on the isolation, identification, and characterization of pharmaceutical impurities.
Protein Simple iCE3
Capillary electrophoresis system featuring a PrinCE autosampler.
Endosafe
Microbiology testing system for endotoxin detection.
Agilent HPLC
Liquid chromatography equipment featuring multiple detectors including UV, PDA, FL, RI, ELS, and a fraction collector.
GE AKTA Pure Chromatography system
Purification and chromatography system designed for proteins, peptides, and nucleic acids.
Process Development of Conjugated Biologics
Bioconjugation services from Discovery through Process Development and Technical Transfer to a CMO for bioconjugates including ADCs, Vaccine conjugates, and Oligonucleotide conjugates.
Impurities Isolation, Identification and Characterization
Specialized analytical services focused on the isolation, identification, and characterization of pharmaceutical impurities.
Protein Simple iCE3
Capillary electrophoresis system featuring a PrinCE autosampler.
Endosafe
Microbiology testing system for endotoxin detection.
Agilent HPLC
Liquid chromatography equipment featuring multiple detectors including UV, PDA, FL, RI, ELS, and a fraction collector.
GE AKTA Pure Chromatography system
Purification and chromatography system designed for proteins, peptides, and nucleic acids.
Services
cGMP-compliant analytical testing services from early development through commercial release, including compendial testing where applicable.
Development and validation of stability-indicating HPLC, charge-based, GC and mass-spectrometry methods and tech transfer of validated methods to clients or CMOs.
Discovery and scale-appropriate development of conventional and site-specific conjugation chemistries for ADCs, AOCs, vaccine conjugates, oligonucleotide and polysaccharide conjugates with full characterization.
Optimization of conjugation/purification using DOE, preparation of low-endotoxin materials for toxicology, and delivery of GLP characterization and reports.
Preparation of technical transfer protocols and batch records, oversight of demo runs and person-in-plant oversight during CMO manufacture, plus regulatory guidance during transfer.
Formulation optimization and stability testing for early and late-stage candidates to inform shelf-life and storage conditions.
cGMP-compliant analytical testing services from early development through commercial release, including compendial testing where applicable.
Development and validation of stability-indicating HPLC, charge-based, GC and mass-spectrometry methods and tech transfer of validated methods to clients or CMOs.
Discovery and scale-appropriate development of conventional and site-specific conjugation chemistries for ADCs, AOCs, vaccine conjugates, oligonucleotide and polysaccharide conjugates with full characterization.
Optimization of conjugation/purification using DOE, preparation of low-endotoxin materials for toxicology, and delivery of GLP characterization and reports.
Preparation of technical transfer protocols and batch records, oversight of demo runs and person-in-plant oversight during CMO manufacture, plus regulatory guidance during transfer.
Formulation optimization and stability testing for early and late-stage candidates to inform shelf-life and storage conditions.
Expertise Areas
- Bioconjugation process development (ADCs, AOCs, vaccine conjugates, protein-polysaccharide conjugates)
- Analytical method development and validation
- GMP analytical testing for biologics
- Purification and downstream processing (SEC, HIC, IEX, TFF)
Key Technologies
- High-performance liquid chromatography (HPLC)
- Hydrophobic interaction chromatography (HIC)
- Size-exclusion chromatography (SEC)
- Ion-exchange chromatography (IEX/CEX)
News & Updates
Formal ribbon cutting for the company at the New York Center for Innovation; event and company opening details and leadership introductions.
Announcement of company opening and overview of capabilities, noting location at New York Center for Innovation and readiness to provide GMP analytical and process development support.
Summary of 2024 accomplishments including AOC preparation, protein-polysaccharide conjugates, site-specific and conventional ADC conjugation, method development/validation for late-stage assets, formulation and stability studies, and reference standard preparation.
Company summary noting preparation/characterization of numerous bioconjugates, validated analytical methods, GMP analyses, repeat clients and IND/BLA filing experience.
Year-in-review describing team hires, added assays (ELISA, BCA), development of vaccine conjugate processes, low-endotoxin material prep, AAV characterization methods, and quality system enhancements.
Created a fully compliant analytical laboratory providing cGMP testing from Phase 1 to commercial.
Formal ribbon cutting for the company at the New York Center for Innovation; event and company opening details and leadership introductions.
Announcement of company opening and overview of capabilities, noting location at New York Center for Innovation and readiness to provide GMP analytical and process development support.
Summary of 2024 accomplishments including AOC preparation, protein-polysaccharide conjugates, site-specific and conventional ADC conjugation, method development/validation for late-stage assets, formulation and stability studies, and reference standard preparation.
Company summary noting preparation/characterization of numerous bioconjugates, validated analytical methods, GMP analyses, repeat clients and IND/BLA filing experience.
Year-in-review describing team hires, added assays (ELISA, BCA), development of vaccine conjugate processes, low-endotoxin material prep, AAV characterization methods, and quality system enhancements.
Created a fully compliant analytical laboratory providing cGMP testing from Phase 1 to commercial.