Process Development and Manufacturing for mAbs

• Desarrollo de líneas celulares
• Media and Buffer Development
• Pre- and Sterile Filtration
• Bioreactors

• Clarificación
• Prefiltration & Bioburden
• Cromatografía de afinidad
• Inactivación de virus
• Polishing Chromatography
• Eliminación de virus
• Concentration & Diafiltration

• Formulación
• Filtración final y llenado

Scalable, traceable, pure, and cost-effective cell culture is critical for mAb production.

Buffer and media prep are crucial for efficient, safe, and high-yield manufacturing.

Clarification reduces bioreactor impurities for downstream purification.

Downstream purification includes one or more chromatographic separation steps to purify molecules.

Bioburden control is critical to assuring the microbial safety of drugs for patients.

Viral safety relies on the principles of "prevent, detect and remove".

Ultrafiltration & diafiltration increase capacity, concentration, and recovery in bioprocessing.

Several formulation approaches can have an impact on the success of biologics.

Upstream process intensification enhances efficiency and flexibility for biopharma.

Process intensification enables the downstream suite to be more efficient, faster, and sustainable.

Closed processing mitigates contamination risks, and enables sustainable multi-modal manufacturing.

PAT ensures quality in mAB manufacturing by monitoring and controlling processes in real-time.

Biotech firms need smart data management tools that automatically collect data from disparate sources. 

Automation and control software increases process reproducibility, and optimizes uptime.