cGMP Upstream Processing for CGT

Rentschler Biopharma CDMO cell expansion in cGMP upstream processing for CGT

Cell expansion, a crucial step in cGMP upstream processing for CGT, is carried out in shake flasks within a dedicated room that boasts a BSC qualification at grade A standards. This ensures cells are expanded from a starting point of 1 mL cryovial to a substantial 3.2 L volume before transfer to the production room.

We utilize state-of-the-art, fully closed single-use aseptic connectors for expanding cells in a rocking bed (Wave) bioreactor, followed by a transfer to stir tank bioreactors (XDR) for the critical processes of transfection and virus production, currently scaling up to 200 L.

  • Bioreactors up to 200 L scale
  • Cutting-edge, validated manufacturing equipment
  • Flexible and independent manufacturing suites
  • Streamlined scale-up and seamless technical transfer
  • cGMP-regulated, secure warehousing facilities

cGMP Downstream Processing for CGT

We’ve meticulously designed our cGMP downstream processing for CGT to deliver tangible advantages for our clients. Our processing stands out with its strategic use of detergent-based lysis and DNase treatment. This is followed by advanced multi-layer filtration (reaching up to 0.2µm) to refine the harvest. We utilize hollow-fiber-based methods for concentration/diafiltration and employ multiple ready-to-use chromatography processes to purify the product and eliminate contaminants.

The final stages involve further product concentration and buffer exchange through a single-use TFF system. The final filtration of the bulk drug substance is executed in a BSC qualified to grade A, ensuring the utmost purity before it’s stored and carefully prepared for shipment to your designated location.

Rentschler Biopharma CDMO downstream processing for CGT

Rigorous Quality Control

Our commitment to unmatched CGT manufacturing quality is evident through our dedicated in-process control laboratory that is on-site. Comprehensive drug substance characterization and rigorous release tests are conducted in our new state-of-the-art QC laboratory, and our extensive network of trusted and qualified partners adds depth to our quality control capabilities.

Rentschler Biopharma CDMO rigorous CGT manufacturing quality control

We work hand in hand with our esteemed strategic partners to offer unrivalled CGT manufacturing, release testing, and stability evaluations.

  • Quality person (QP) certification for every batch: We take an extra step by providing QP certification for each and every batch we produce. This meticulous oversight reflects our dedication to maintaining the highest standards.
  • MHRA-approved cGMP license: Our MHRA-approved Good Manufacturing Practice (cGMP) license empowers us to manufacture CGT products to support your Phase I-III clinical trials. This regulatory endorsement underscores our unwavering commitment to adhering to the most stringent industry standards.
  • Comprehensive Quality Management System (QMS): Our QMS underpins every aspect of the manufacturing process. It seamlessly integrates every stage — from initial concept to the production of bulk drug substances. This system ensures the strict observance of cGMP principles throughout, guaranteeing the safety, efficacy, and quality of your gene therapy.

Our AAV Production Platform’s Distinct Features

Rentschler Biopharma AAV process


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