As contract research organization, BIA Separations’ facilities are fully equipped to handle process and analytical method development for particles up to biosafety level 2. Our sales and technical support team will prepare a work plan per your requirements. You may choose to be involved throughout the development via regular contact with the project manager.
Downstream process development:
- Processes suited to different clinical phases up to market supply – developed exclusively on monolithic columns.
- Starting from lysis or capture, to final polishing and formulation of your biomolecule (viruses, pDNA, bacteriophages, extracellular vesicles, proteins, PEGylated proteins, etc.).
- Depending on your product and requirements the multistep process includes development of lysis method, chromatographic media selection and optimization, virus inactivation, filtration, tangential flow filtration.
- Recommendation of suitable analytical methods.
- Tech transfer of standard operating procedures (SOP) to your facility or CMO.
HPLC analytical methods:
- Methods for in-process control (PAT). Developed to increase control, improve efficiency and prevent rejecton of batches of your upstream and downstream.
- Methods for final control, that enable real time release of products.
- All methods can be validated. BIA’s HPLC methods use CIMac™ Analytical Monoliths and are developed on PATfix™ along with reference methods for characterization.
Development and validation of various analytical methods:
- Method development, validation and verification, transfer and routine testing of pharmaceutical samples and biomolecules.