Quality by Design Process and Analytical Development
Developing robust manufacturing processes and analytical methods which reliably produce and quantify the critical characteristics of your product is paramount to seamlessly transitioning your therapy to cGMP manufacturing.
Whether your objective is to fast-track your current process or you’re taking your first steps towards cGMP, Landmark Bio’s robust menu of Process Development (PD) and Analytical Development (AD) Services will help to accelerate your advanced therapy to the clinic.
Landmark Bio’s comprehensive and phase-appropriate development services will safeguard the authenticity, integrity, and efficacy of your program and ensure cGMP-readiness
Process Development
The Landmark Bio laboratories and staff are armed with a diverse technology toolbox to enable, optimize and develop phase-appropriate cGMP-ready processes. The company’s expertise and toolbox include:
Purification and isolation of viral vectors, gene-modified cells, or other therapeutic products utilizing column/membrane chromatography, tangential flow filtration, depth filtration, and more.
Development, optimization and scale-up of cell culture processes, including selection of cell lines, media, bioreactor operating parameters, and growth conditions to maximize yield and quality of viral vectors or cell products.
Analytical Development
Landmark Bio provides comprehensive Analytical Development Services to ensure phase-appropriate method development, qualification and verification. Our Analytical Development scientists leverage a deep toolbox of technologies suitable for a broad range of advanced therapy modalities.
Development, qualification and validation of assays
for purity, identity, potency and safety
Phenotypic (flow/nano flow cytometry), Molecular biology (PCR, electrophoresis, ELISA, UV/Vis, etc.), Biophysical (UPLC, particle analyzer, etc.)
In-process and release assay development
Development of in-process and release technologies
Custom assay development
Derisk and Accelerate your Advanced Therapy Program
Landmark Bio leverages wide-ranging PD and AD experience, and as your partner we will ensure an accelerated and derisked transfer of processes and methods to cGMP and Quality Control.