Biologics Development
Comprehensive Solutions from Discovery to Commercial Supply
Anthem Biosciences offers integrated services to support your biologics pipeline—from cell line development through upstream and downstream process optimization to analytical characterization—ensuring your product meets quality and regulatory standards for clinical and commercial success.
Cell Line and Strain Development
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Host Systems
- Mammalian: CHO GS-/-, HEK293, Sp2/0 for complex glycosylated proteins.
- Microbial: E. coli, Bacillus subtilis for rapid, cost-effective protein production.
- Yeast: Pichia pastoris, Saccharomyces cerevisiae for secreted proteins.
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Capabilities
- Gene design and expression construct optimization.
- Stable clone/strain development and stability assessment.
- Tailored host selection to balance yield, quality, and scalability.
Upstream Process Development
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Culture Strategies
- Batch, fed-batch, and perfusion processes optimized for maximum yield and product quality.
- Process modulation to ensure biosimilar comparability and novel biologic robustness.
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Scale-Up & Tech Transfer
- Seamless scale-up from lab to commercial bioreactors (up to 30,000 L).
- Process characterization and documentation to support regulatory filings.
Downstream Process Development
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Purification & Recovery
- Affinity, ion exchange, and size-exclusion chromatography.
- Ultrafiltration, diafiltration, and lyophilization for product concentration and stabilization.
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Process Qualification
- Use of scale-down models to optimize yield and purity.
- Technology transfer to GMP manufacturing sites ensuring reproducibility.
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Product Expertise
Extensive experience with monoclonal antibodies, recombinant proteins, and enzymes.
Analytical Development and Characterization
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Method Development & Validation
- cGMP-compliant analytical methods for identity, purity, potency, and safety.
- Method transfer to manufacturing sites ensuring consistent quality control.
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Quality Control & Stability
- In-process, bulk intermediate, and drug substance testing.
- Stability studies under various conditions to establish shelf life and storage.
Partner with Anthem Biosciences to leverage our comprehensive biologics development expertise, accelerating your therapeutic candidates from clinical trials to commercial success with confidence and compliance.