- Molecular Biology
- Viral Vectors & Cell Engineering
- Protein Engineering & Production
- Antibody Discovery & Engineering
- Antibody Production
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Analytics & Formulation
- Overview
- Purity Analysis by CE-SDS
- Aggregation Analysis
- Charge Variant Analysis
- De Novo Antibody Sequencing
- Intact Mass Analysis
- Sequence Confirmation by Mass Spectrometry
- N-terminal Sequencing
- Post-Translational Modification
- N-glycan Analysis
- Thermostability Analysis
- Stability Analysis
- Formulation Development
- Developability Analysis
- R&D and cGxP Bioassay Development
- Protein Chemistry
- Development & Manufacturing in LakePharma Hayward, CA
- Development & Manufacturing in LakePharma Hopkinton, MA
- Consulting Services
Analyte-Specific Reagent Manufacturing
Analyte-Specific Reagents (ASR) are defined as biological compounds that are utilized as diagnostic tools for the detection and quantification of individual compounds within a specimen. LakePharma offers integrated solutions for ASR from discovery to GMP-manufacturing.LakePharma offers manufacturing services of ASRs in its ISO 9001:2015 certified facilities in the United States. Materials can be produced under two different grades:
- cGMP: Complete Quality Management System oversight and compliance, instrument IQ/OQ/PQ, raw material supplier verification, and batch record documentation.
- Bioprocessing Grade (BPG): Instrument IQ/PQ, raw material supplier verification, and batch record documentation
Both LakePharma's TunaCHO™ and CHO-GSN™ expression platforms can be used in the development & manufacturing of ASRs:
- TunaCHO™ transient development & manufacturing
- Quick turnaround time
- 1 L - 100 L production tailored for specific needs
- CHO-GSN™ stable cell line development & manufacturing
- Robust, high performance
- Flexible production scale
Various customization options for the final product are available
- Concentration and fill/finish
- Release criteria
- Quantity
To download LakePharma's Integrated Solutions for ASR Manufacturing presentation, click here.
To download discovering diagnostics with LakePharma's ASR solutions flyer, click here.