Process Development (Upstream and Downstream)

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Upstream

Built-in Quality by Design (QbD) in our process development reduces process variability yielding robust reproducible processes to be scaled up to the final manufacturing scale (up to 1,000L) with a reduced timeline.

We have solid experience with both microbial and mammalian cell culture derived proteins such as:

  • Monoclonal antibody

  • Bispecific antibody

  • Fusion protein

  • enzyme, and bioconjugates

We are fully capable of producing viral vectors with either suspension-based platforms or adherent platforms for pre-clinical research studies. 

We at Menarini Biotech work with our clients to streamline their Process/ product development and maximize yield.

Our capabilities: 

Process development

  • Culture media evaluation and optimisation

  • Cell line growth (duplication rate, cell metabolism and productivity) characterization and optimisation

  • Research Cell Bank Generation

  • Screening and identification of critical process parameters based on quality by design approach, with definition of process control strategies

  • Pre-Clinical material supply (Toxicology run)

  • Scale up to GMP scale 

  • Scale down and process characterization

  • Harvest optimization to increase product yield and reduce impurities. 

Results: the application of the upstream develepoment flow, in particular the QbD apporoach with DoE analysis and the use of our platform, allowed a significant invrease of the final productivity of the two example processes expressing two different monoclonal antibodies.

Downstream

Menarini-Biotech (MBH) offers services for DSP process development of biotechnological products focusing on increasing efficiency of purification and reducing development timelines using the HT technologies available. In MBH we tailor the processes on you, the client needs and specifics, selecting the best applicable solutions for chromatographic media, tangential flow filtration membranes and virus removal filters building QbD from the start of process development.

MBH has established purification platforms for monoclonal antibodies and bispecific antibodies which allow shortening timelines and effort to transfer the process in manufacturing.

MBH can support clients performing scale down models on laboratory scale validating the process and ensure the scalability.

Services

  • Purification platform for monoclonal and Bispecific antibodies

  • Optimization and development of purification process for different classes of molecules

  • High-throughput screening of chromatographic media in a DoE approach

  • Scale down validation models

  • Tangential flow filtration steps development and optimization

  • Early stage liquid formulation development.