LeanWays

“It’s so much easier to suggest solutions when you don’t know too much
about the problem.” – Malcolm Forbes

LeanWays

“It’s so much easier to suggest solutions when you don’t know too much about the problem.” – Malcolm Forbes

Process Development, Scale Up & Technology Transfer

Process development is the art of ensuring that what you have in mind for your product will become what you expect. You start first on individual unit operations, using a Quality by Design approach, focus on identifying those

Critical Process Parameters (CPP) which could affect the product Critical Quality Attributes (CQA). All based on sound scientific methods and principles, in combination with risk management tools which are applied throughout the development process.

Scale up is the migration of a process from the lab-scale to the pilot plant-scale or commercial scale, increasing capacity.

Technology transfer occurs when you have to move the process or equipment from one site to another.

For which industries can it be useful?

For all manufacturing industries dealing with increased demand opportunities.

We help your business by:

  • Supporting you in the development of new or current technologies and processes, in the pilot scale up to the commercial scale, alongside your partners (CMOs, Engineering firms, customers).
  • Providing insight & troubleshooting expertise for processes and equipment.
  • Supporting you in the development of a Cost of Goods model (COGS).

For pharma and biotech processes:

  • We accompany you in the manufacturing of clinical trials, compliant with current GMPs and regulations.
  • We support you from the URS definition all the way to the FAT and SAT activities (Factory and Site Acceptance Testing), as well as the Commissioning and Qualification of equipment and process.
  • We assist you in the Financial Impact Assessments on equipment and process upgrades and changes.

For all industries:

  • We can help you in the Layouts of the shop floor.
  • We ensure management of the project directly with the End User, be it your company’s site or a Contract Manufacturing Organization (CMO).
  • We support you in the management of your
    suppliers.