Comprehensive Protein Expression Services for Every Stage of Drug Development
America Diagnostics offers end-to-end protein production services tailored to meet the evolving demands of biopharmaceutical R&D. Our platform bridges the gap between early research and clinical development, ensuring seamless scalability from micrograms to kilograms of high-quality protein.
Key Service Offerings
1. Early-Stage Research Support (Microgram to Milligram Scale)
- Transient Expression (HEK293/CHO): Rapid turnaround (2 weeks) for small-scale protein production, ideal for physicochemical characterization, *in vitro* assays, and preliminary screening.
- Bioinformatics & Sequence Analysis: AI-driven predictions of protein properties (e.g., stability, solubility) to prioritize candidates without physical material.
2. Preclinical Development (Gram to 100g Scale)
- Stable Pool Expression: Proprietary cell line engineering (e.g., EncorePOOL® Technology) enables high-yield, scalable production in 3–4 weeks, bypassing lengthy clonal selection.
- Fit-for-Purpose Material: Supply gram-level proteins for animal PK/PD studies, formulation development, and toxicology assessments, ensuring data reliability and regulatory compliance.
3. Clinical & Commercial Manufacturing (Kilogram Scale)
- Large-Scale Bioreactors: cGMP-compliant facilities for high-density perfusion cultures, delivering ton-scale proteins with consistent quality for pivotal trials and commercialization.
Technology Differentiation
- EncorePOOL® Platform:
- Speed: Achieve gram-level yields in <4 weeks vs. industry-standard 6–14 weeks.
- Scalability: Seamless transition from 1L to 2,000L bioreactors without yield loss.
- Quality: Eliminate batch-to-batch variability between transient and stable expression systems.
- Integrated Analytics: Real-time monitoring of critical quality attributes (CQAs) to meet ICH guidelines.
Applications
- Developability Assessment: De-risk molecules through in silico modeling, stress testing, and forced degradation studies.
- Animal Studies: Supply GLP-grade proteins for robust in vivo pharmacology and safety evaluations.
- Process Development: Support DoE (Design of Experiments) with high-purity material for downstream optimization.
Why Partner with America Diagnostics?
- Cost Efficiency: Competitive pricing for gram-scale projects (starting at $15K/sample), leveraging high-throughput automation.
- Speed-to-Data: Shortest industry lead times—3 weeks for gram-level material.
- Regulatory Expertise: Full documentation (CoA, batch records) aligned with FDA/EMA requirements.
Contact Us
Unlock your molecule’s potential with America Diagnostics’ cutting-edge protein solutions. Visit [website] or email [contact] to schedule a consultation.
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America Diagnostics, 9235 Activity Road, Suite 101, San Diego, CA 92126 USA Tel: (858) 282-8567 Email: info@ameridx.com
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