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Designing Scalable, Safe & Economical Processes

Technology Transfer is a critical cross-functional process for achieving timely and successful delivery of your drug substance. It involves meticulous planning, accurate documentation, eicient procedures and skillful handling by our own specialists. The team at Sai Life Sciences delivers best-in-class technical services for scale-up and manufacturing and plays a strategic role in designing scalable, safe, and economical processes.

Designing Scalable, Safe & Economical Processes

Role of the Technology Transfer team

  • Selection of fit for purpose plant, machinery, and
    technology
  • Developing in-depth understanding of customer needs
    and process benefits to develop campaign reports
  • Seamless technology and knowledge transfer from the
    bench to the plant across all geographies
  • Executing the scale-up process under the close and
    comprehensive monitoring of process engineers to
    ensure reproducibility and further refinement of
    subsequent procedures
  • Utilizing a range of software tools such as Dynochem,
    AspenOne, and MixIT to anticipate process performance under varying scales and operating conditions. Through process simulation, engineers can fine-tune essential parameters to achieve first time right scale-up and enhance process efficiency.

Tech Transfer workflow

  • Process understanding
  • Process reproducibility at different scales
  • Process monitoring

Highlights

  • Experienced in scaling up process from fume hood to
    plant with factors of up to x20,000
  • Mitigate scale-up risks by planning for extended unit
    operation time for processes like heating, cooling,
    extraction, distillation, filtration and drying
  • Pilot plant with miniature equipment in line with the
    parent plant
  • Extensive experience ranging from early phase, late
    phase and commercial APIs
  • Successful transfer of 150 process steps annually with
    high quality and reliability along with incremental
    growth every year
  • Well qualified engineers (B.Tech / M.Tech and PhD in
    Chemical engineering) from premium institutes in India
  • Lead Engineers with 12-18 years experience and
    Process Engineers with up to 10 years experience
    with versatile process knowledge capable of
    leading teams efficiently and driving multiple
    projects.
  • Dedicated Team of Engineers for Process
    Modelling and Simulation studies to support
    Process Development and Scale up.
Technology Transfer Workflow

Internationally validated approach

  • Case study in International Society for Pharmaceutical
    Engineering (ISPE) – Good Practice Guide: Technology
    Transfer, 3rd Edition, 2018,