Qepler | summits & conferences | Pharmaceutical Lyophilization Summit, Prague, 13 February 2019
Event Location:
Prague, Czech Republic
Date:
13 February 2019 - 14 February 2019
Language:
English

Early Bird discounts:
Register early to save €500 for the Individual ticket, €600 per person for 2-3 Delegates, €700 per person for 4+ delegates from the same company until November 16.

Contact Person: Evgenia Makar
Contact Person: Evgenia Makar, Qepler s.r.o.
Contact Person: Denis Polikarpov
Contact Person: Denis Polikarpov, Qepler s.r.o.

Conference Overview

Although lyophilization is an old process, it remains to be complex. Today we can see increased trend in aseptic freeze-dried products, including biologics, APIs, nanomaterials and new devices. It makes the lyophilization cycle more complicated. Lyophilization becomes systematic and scientific process.

Pharmaceutical Lyophilization Summit 2019 is a knowledge sharing to showcase best practices in technical and regulatory updates, manufacturing and process development, freeze-dried formulation, testing, monitoring and new products development.

The featured talks on:

  • Latest regulatory updates in lyophilisation. Preparation for the regulatory review and inspection.
  • Lyophilisation process development. Process optimisation, monitoring, and control. Model-based process engineering.
  • Risk-based approaches to design and development of drug delivery systems
  • Lyophilization cycle development, optimisation and improvement: real practical examples.
  • Scale-up development and validation of lyophilization processes.
  • Technology transfer from one lyophilization model to another. Predictive models of lyophilization Process.
  • Media Fill design. Validation of lyoprocess. Requirements. Current trends.
  • QbD and PAT approaches. Space design for lyophilization. QbD aspects and determination of critical process parameters.
  • Continuous freeze drying.
  • Innovations in formulation development.
  • Lyophilized formulation: prediction and optimization of stability.
  • Organic co-solvents and their effect on the formulations.
  • New methods to evaluate moisture and formulation effects on the stability of freeze-dried biologics.
  • Container Closure Integrity Testing.
  • Secondary drying and residual moisture monitoring.
  • Freeze drying of novel products: mAbs, bacterial, viral or gene therapy-based products. Challenges in cycle development. New excipients.
  • Lyophilisation in dual chamber cartridges. Process challenges, design and control.
  • New Developments in materials and devices.
  • Advanced vials and novel vial identification approaches.
  • Automatic loading and unloading technologies and robotics. Reasonable limits of automation. Upgrading possibilities.
  • Controlled nucleation techniques. Recent developments. Challenges. Experimental and stability data. Impact on quality and stability of lyophilized biologics.
  • Wireless Technologies. Wireless multipoint temperature sensors for lyophilization monitoring.
  • Other new innovations in lyophilization applications.

Meet our Speakers

PREVIOUS EVENT

Networking

Harshal Shah

Cambridge Consultants

chaired a panel discussion on the digitisation of clinical trials and next gen injectable devices, with speakers from Novartis, Roche, Janssen, Sanofi, SHL Group and Corvus Device.