As contract research organization, BIA Separations, a Sartorius company’s facilities are fully equipped to handle process and analytical method development for particles up to biosafety level 2. Their 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.