Biologics

Biophysical Profiling and Characterization to Advance Complex Molecules

Absorption Systems provides state-of-the-art preclinical formulation profiling and characterization of biologics. Our team is focused on streamlining the process and clinical development to expedite your biotherapy’s commercialization.

• Polypeptides
• Recombinant Proteins
• Monoclonal Antibodies
• Protein Conjugates
• Nucleic Acids
• Viral Vectors
• Vaccines


Explore and interpret the potential consequences of unoptimized biologic stability

• False-negative results during proof of concept studies
• Altered PK or PD results
• Aggregation-induced activity losses and safety risks (e.g., immunogenicity)
• Reduced shelf life necessitating more frequent production
• Production losses from unstable process streams reducing product yield and increasing cost of goods


Scientific expertise spanning two decades of biologic development and commercialization

Comprehensive determination of conditions suitable for the formulation, production, storage, transport, and stability of biopharmaceuticals, including biosimilars, and vaccines.

Consultative guidance for a variety of biologics including peptides, recombinant proteins, monoclonal antibodies, protein conjugates, nucleic acids, viruses, and virus-like particles.

Excipient library containing over 150 entities including those generally-recognized as safe (GRAS), found in approved parenteral formulations, or known to stabilize biomolecules.

Recommendations for establishing design space for critical quality attributes and critical process parameters.

 

Capabilities

 

Stability Enhancement
pH and Buffer Optimization
Excipient Screening and Optimization
Thermodynamic Stability
Protein Stability Curves
Aggregation Content
Accelerated Stability
Freeze-thaw Studies
Surface Absorption

Solubility Profiling
Solubility Determination
Solubility Optimization

Biophysical Characterization
Temperature Melts
Chemical Denaturant Transition Curves
Intrinsic Fluorescence
Extrinsic Fluorescence
Size Determination (rh)
Conformational Heterogeneity
Viscosity Determination

Biophysical and Analytical Technologies
UV Derivative Spectroscopy
Turbidity Spectroscopy
Fluorescence Spectroscopy
Dynamic Light Scattering
High-Throughput Differential Scanning Calorimetry
High-Performance Liquid Chromatography
Osmometry

How can I help?

Lisa Murray
Business Development Manager
lmurray@absorption.com
610-280-1496

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Recommended Resources
Biologics Overview

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