Biologics Analytical Services for Reliable Drug Development
Developing safe and effective biologics requires robust analytical strategies that span the entire lifecycle. From early-stage discovery through late-phase clinical trials and commercial market supply, precise biologics analytical services ensure safety, efficacy, and regulatory compliance. Comprehensive analytical testing, release and stability testing, and analytical method development are critical to meeting the expectations of global health authorities and to bringing advanced large molecule therapies successfully to market.
Analytical Excellence for Biologics
At ProtaGene, we specialize in biologics analytical services designed to accelerate drug development, de-risk programs, and meet the highest regulatory requirements. We provide comprehensive analytical support, spanning drug substance and drug product characterization, method development, and large-scale QC testing. We provide validated analytical methods that cover all molecule‑specific characteristics. By integrating analytical tools and compliance-driven systems, we generate actionable data for decision-making. Together with clients, we identify critical quality attributes (CQA) and define acceptance criteria to support successful regulatory submissions.
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We are fully resourced to manage complex analytical testing and high-volume QC programs. With cutting-edge technology, flexible service models, and global reach, ProtaGene ensures that even the most challenging analytical projects are executed with precision and reliability.
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Integrated Biologics Analytical Services
We deliver end-to-end biologics analytical services that support every stage of the product lifecycle. Our integrated approach combines drug analytics, method validation, and process development support with regulatory compliance and industry best practices. Specialized labs provide advanced capabilities such as mass spectrometry, cell-based assays, and the use of state‑of‑the‑art physico‑chemical techniques.
Method Development & Validation
As an advanced analytical CRO, ProtaGene performs phase-appropriate method validation packages in compliance with global regulatory standards.
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State-of-the-art analytical method development based on platform methods and QbD approach
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Full method validation aligned with FDA, EMA, and ICH guidelines
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Seamless method transfer from development labs into QC operations, including transfer to and from clients
Drug Substance and Drug Product Characterization
Accurate drug product characterization services are essential to evaluate the stability and performance of biologics. Our analytical testing programs generate reliable data for both development and regulatory filings.
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In-depth product characterization based on >25 years of biosimilar experience
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Broad biologics analysis for recombinant proteins, monoclonal antibodies, and fusion proteins
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Identification of critical quality attributes (CQA) to ensure safety and efficacy
GMP Release and Stability Testing
Reliable drug substance and drug product analysis underpins safe and effective therapies. ProtaGene offers GMP-compliant QC testing that meets strict regulatory requirements.
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Drug substance and drug product release and stability testing
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Analytical methods developed and applied across all stages – from early R&D to commercial supply
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Supporting your control strategy for complex formulations with potentially degrading excipients
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Lifecycle strategies covering stability, release testing, and quality control group assessments
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Complete and integrated documentation for global regulatory submissions
Advancing Biologics Development with Industry-Leading Expertise
At ProtaGene, advancing biologics goes beyond analytical testing — it’s about combining science, compliance, and strategy to help our clients succeed. With decades of expertise in biologics analytical services, we bridge the gap between early research and commercial readiness by providing integrated solutions that accelerate drug development and reduce regulatory risk.
Our teams work closely with sponsors to design programs that anticipate challenges in process development, extended product characterization, and release & stability testing. Leveraging cutting-edge technology and global regulatory insight, we deliver reliable data packages that support confident submissions and faster approval pathways.
By uniting scientific depth with regulatory expertise, ProtaGene ensures that every biologics program moves forward with clarity, quality, and confidence.
Diverse Biologic Therapeutics Platform Expertise
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Recombinant proteins—including complex, highly glycosylated proteins
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Multi-subunit Complexes—Protein, Nucleotide, Ligand
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Monoclonal antibodies (mAbs)
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Antibody drug conjugates (ADCs) and Protein Conjugates
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PEGylated Proteins
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Bispecifics/Multispecifics
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Fusion Proteins
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Enzyme Replacement Therapies
Why ProtaGene?
- Extensive expertise in protein and gene analytics
- Broad single-vendor analytical offering from discovery to market
- Global facilities with scalable QC programs
- Best-in-class quality supporting robust regulatory packages
- Trusted partner for leading pharmaceutical industry innovators
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Talk to Our Experts
Global pharma and biotech companies trust ProtaGene’s biologics analytical services to accelerate development, ensure compliance, and bring safe therapies to patients faster. Partner with ProtaGene for proven expertise in drug product analytics, validated analytical methods, and regulatory-ready programs. Our expert team will help you find the right solution for your project.
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