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

The call for speakers is open now.
Please find below the tentative schedule. Speaking sessions will be grouped according to similar themes into blocks and published upon finalizing the agenda, so please check back!

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.