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Quick Check for Biotech Companies: In-Process Controls and Process Analytical Technology (PAT)

Highlights

  • Review of¬†in-process controls and process analytical technologies¬†for¬†biotechnological production processes in respect to process robustness, QbD maturity and transferability
  • Ranking¬†of¬†relevant¬†information vs. costs¬†for the process analyzers and¬†sampling-/ and analytical strategies applied
  • Report¬†on in-process controls and PAT maturity by biotech process experts

Benefits

  • Identify weak spots¬†and gaps¬†to avoid costly iterations in process development and process changes at a later stage
  • Identify possibilities to reduce costs¬†by revising in-process controls and applied process analytical technologies (PAT)
  • Embed the PAT and in-process controls¬†in a holistic framework for robust¬†scale-up and manufacturing,¬†in-line with current regulatory guidelines

The Quick Check for Biotech Companies: Process Analytical Technology (PAT) and Process Control Strategy is applicable for following product categories and production systems:

Product categories, production systems and process steps

  • Biobased materials
  • Biologics
  • Mammalian cell culture processes
  • Microbial production systems
  • Plant cell production systems
  • Raw materials
  • Fermentation
  • Primary recovery
  • Downstream

Pricing

The Quick Check for Biotech Companies: In-Process Controls and Process Analytical Technology (PAT) is priced at EUR 3’500,- excl. VAT, includes three¬†consulting days of a process technology¬†expert, post-analysis of PAT- and control strategy maturity and a comprehensive report.

‚ā¨ 3'500,-
sales@exputec.com
Tel.: +43 1 997 28 49
Learn more

As a biotech company with a promising product pipeline, you are responsible for designing¬†a manufacturing process capable of robust manufacturing at large scale. “Robustness” is¬†the required ability of your process to “... tolerate¬†the expected variability in raw materials, operating conditions, process equipment, environmental conditions, and human factors” (APQRI White Paper).¬†Process robustness is vital¬†for the success of your product¬†from an economic perspective (avoid failed-batches, achieve consistent yields) as well as an imperative from the regulatory authorities.

State-of-the art in-process controls and process analytical technology (PAT) provide information on the manufacturing state before the manufacturing process is finished. These data feed an appropriate control strategy which enables to perform necessary process adaptions to ensure to meet the product specifications, achieve constant yields and avoid failed batches. Today, the possibilities to extract chemical, physical and biological data from manufacturing processes are manifold which enables biotech companies to establish cost-effective in-process controls and process analytical strategies.

Exputec is the leading biotech consulting and data science company with many years of experience in process analytical technologies and in-process controls for biotechnological production systems. Exputec has combined best-practices to a comprehensive and proven methodology to check in-process controls and applied process analytical technologies.

Technology driven services

With the Quick Check for Biotech Companies: In-Process Controls and Process Analytical Technology (PAT), Exputec has developed a unique service addressing the needs of biotech companies to progress and rationalize in-process controls and applied process analytical strategies. The service identifies gaps in applied in-process controls and PAT and thereby progresses the robustness of the manufacturing process. This is conducted by a team of biotechnology PAT experts, in close collaboration with the customer.

Streamlined project workflow

The Exputec Quick Check for Biotech Companies: Process Analytical Technology (PAT) and Process Control Strategy follows a clear roadmap: First, confidentiality agreements are signed and Exputec analyses the manufacturing process and key documents at a one day on-site visit. Exputec biotech consultants check and review the applied in-process controls and process analytical strategies in the light of the product specifications. This is done in a close collaboration with the biotech- upstream-, downstream- and quality department

Comprehensive report

The analysis is post-processed by Exputec PAT experts based on reference best practices. This enables an early detection of gaps and avoid costly do-overs and iterative process development cycles. The report contains following main topics and is presented in a meeting.

  • Review of rationales for in-process controls and applied PAT strategy
  • Identification of gaps in in-process controls and applied PAT strategy
  • Ranking of in-process controls/ PAT: costs vs. information and maturity

Project phases

1. Start phase
  • Confidentiality agreement
  • Analysis of key documents related to manufacturing process and PAT/in process control strategy
2. On-site analysis
  • Workshop on in-process controls and PAT in the light of the product specifications
  • Analysis of applied technologies
3. Report
  • Post-processing based on best practice library
  • Ranking of costs vs. required information
  • Comprehensive project report