COMPLETE ANALYTICAL SOLUTIONS FOR BIOLOGICS

ARL Bio Pharma is a contract testing laboratory that assists biotechnology and pharmaceutical innovators in developing safe and effective therapies. Our laboratory offers comprehensive analytical and microbiological testing to evaluate product safety, stability, and quality at every stage of drug development, from formulation to regulatory submission.

Leveraging comprehensive technologies such as high-resolution mass spectrometry, qPCR, and ELISA, we analyze the molecular structure, purity, and consistency of small molecules, monoclonal antibodies, peptides, and cell and gene therapies, empowering clients to make informed decisions and expedite their product’s time-to-market.

Dr. Qiang Liu, ARL Chief Scientific Officer, emphasizes, “Our lab is an extension of our clients’ research teams, delivering critical insight and support at every step of the process.”

“At ARL, we view science as more than data; it is built on trust,” affirms Dr. Thomas C. Kupiec, ARL President and CEO. “Our mission is to help our partners bring their therapies to patients safely and quickly.”

ARL Bio Pharma is FDA-registered, DEA-licensed for Schedules I through V, and ISO 17025:2017 accredited.

SMALL MOLECULE ANALYTICAL SERVICES

  • Stability Studies
  • Compatibility Studies
  • Raw Material Testing
  • Dissolution Testing
  • Pharmacokinetic/Pharmacodynamic Studies
  • Preclinical and Clinical Analytical Testing

BIOANALYTICAL SERVICES

Characterization

  • Intact Mass and Charge Variants
  • Glycoform Profiling
  • Peptide Mapping
  • Disulfide Bond Mapping
  • Residual Impurities (Host Cell Proteins)

Structural Analysis

  • ADCs and Fusion Protein Analysis
  • Payload Determination
  • Isomer Differentiation
  • PTM Profiling

MICROBIOLOGY TESTING SERVICES

  • Sterility and Rapid Sterility Testing
  • Endotoxin Testing
  • Microbial Identification
  • Mycoplasma Testing
  • Antimicrobial Effectiveness
  • Container Closure Integrity Testing
  • Cleaning Validation Studies

CONTACT ARL BIO PHARMA FOR A QUOTE

(800) 393-1595
info@arlok.com
www.arlok.com