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Quick Check for Biotech Companies: Scale-Up and Technology Transfer

Highlights

  • Identification of most likely scale-up and technology transfer pitfalls
  • Ranking of process maturity and scale-up rationales
  • Check documentation and completeness of key process technology transfer documents
  • Risk mitigation for process scale-up and process design rationales
  • Report on technology transfer readiness by biopharma experts

Benefits

  • Early detection of scale-up gaps
  • Avoid costly do-overs and iterative process development cycles
  • Get it right the first time

The Exputec Quick Check for Pharmaceutical Biotech Companies: Scale-Up and Technology Transfer is applicable for following product categories and production systems:

Product categories and production systems

  • Antibodies
  • Antibody drug conjugates (ADCs)
  • Recombinant proteins
  • Antibody fragments /Fab
  • pDNA
  • Vaccines
  • Mammalian cell culture
  • Microbial production systems
  • Plant cell cultures

Pricing

The Exputec Quick Check for Biotech Companies is priced at EUR 3’500,- excl. VAT, includes three consulting days of a biopharma expert, post-analysis of process maturity and scale-up rationales and a comprehensive report.

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

As a biotech company with a promising product pipeline, you are faced with the challenge of getting your product manufactured under cGMP regulations to be able to enter clinical phase 1 or phase 2. This step involves to scale your process and transfer the process and this may happen internally or by getting a contract manufacturing organization (CMO) on board to realize your GMP product. As a product owner and innovator, you are equally responsible for the manufacturing process to deliver a product that guarantees safety, efficacy and quality. The above task, as for example contracting a CMO to realize your cGMP product, is not a “throw over the fence” exercise and requires close collaboration, involving communication of process-, product and system rationales based on key documents. This step is referred to as technology transfer. The International Conference on Harmonization (ICH) underpins the importance of technology transfer in the ICH Q10 document with following statement:

“The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement.” ICH Q10 3.1.1

Exputec is the leading biotech consulting and data science company with many years of experience in assisting and analyzing the scale-up and technology transfer of biopharmaceutical manufacturing processes involving biologics produced in cell culture, microbial systems as well as ADCs. For safe and predictable scale-up and smooth technology transfer, Exputec has combined best-practices to a comprehensive and proven methodology for scale up and technology transfer.

Technology driven services

With the Exputec Quick Check for Biotech Companies, Exputec has developed a unique service addressing the needs of biotech companies for safe and predictable technology transfer. The service reduces the inherent risks of technology transfer by the evaluation of process scale-up and technology transfer strategies. This is conducted by a team of biopharma process experts, in close collaboration with the customer.

Streamlined project workflow

The Exputec Quick Check for Pharmaceutical Biotech Companies follows a clear roadmap: First, confidentiality agreements are signed and Exputec analyses key documents and the manufacturing process at a one day on-site visit. Exputec biopharma consultants check- and progress in close collaboration with the biotech- upstream- downstream and quality department the technology transfer master plan.

Comprehensive report

The analysis is post-processed by Exputec consultants and allows you an early detection of scale-up gaps and avoid costly do-overs and iterative process development cycles. The report contains following main topics and is presented in a meeting.

  • Identification of most likely scale-up and technology transfer pitfalls
  • Ranking of process maturity and scale-up rationales
  • Check documentation and completeness of key process technology transfer documents
  • Risk mitigation for process scale-up and process design rationales

Process phases

1. Start phase
  • Confidentiality agreement
  • Analysis and on-site discussion of key documents and scale-up criteria
2. On-site Analysis
  • Workshops to discuss critical path and most likely disruption
  • Discussion of identified gaps
3. Report
  • Comprehensive project report
  • Ranking of process maturity for scale-up and technology transfer