Analytical Methods That Drive Regulatory Confidence
BioCina develops, optimizes verifies, validates, and manages analytical methods across drug substance and drug product programs. From early characterization through to cGMP release and regulatory submission, our integrated capabilities keep your program on track and inspection-ready.
Methods That Move With Your Program
Method Development
and Validation
ICH-aligned method development and validation across microbial, pDNA, mRNA, and drug product programs. Methods cover identity, purity, potency, and safety, encompassing physicochemical, microbiological, molecular biological, and immunological analyses.
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01
Stability and Comparability Packages
ICH long-term, accelerated, and stressed stability studies with 24-hour monitored temperature and humidity-controlled chambers. Forced degradation, extractables and leachables (E&L), container-closure integrity, and comparability packages supporting ANDA, NDA, and biosimilar submissions. All data captured in our Laboratory Information Management System (LIMS) for full traceability and regulatory filing.
02
Release Testing and QC
In-process and batch release testing across drug substance and drug product by an integrated analytical development and quality control laboratory team. Reference standard development and qualification performed in-house.
03
Potency and Bioassay Methods
Potency and bioassay method development and testing performed in-house, spanning biologic and nucleic acid programs across the full product lifecycle.
04
Integrated Across the Full Lifecycle
Strengthen Your Analytical Strategy
Connect with our experts to discuss how BioCina's integrated analytical development capabilities support your program from first experiment to regulatory submission.