Qepler | summits & conferences | 3rd Annual Pharmaceutical Lyophilization Online Conference, 18-19 November 2021
Event Location:
Online Conference
Platform:
HOPIN
Date:
18 - 19 November 2021
Language:
English

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 2020 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

Our Sponsors

PREVIOUS EVENT

SNAPSHOT OF ATTENDEES 2020

Allergan - Aptar Pharma - AZBIL TELSTAR TECHNOLOGIES SLU - Baxalta Manufacturing Sàrl - Bayer AG - BB-NCIPD Ltd. - Biopharma Process Systems Ltd - BLAC-BioPharma UG - Boehringer Ingelheim - Datwyler Pharma Packaging International NV - De Montfort University - DendroPharm GmbH - Elm o Sanat University - Freie Universität Berlin - Ghent University - INDICAL BIOSCIENCE GmbH - Janssen - KSHM-Rezonanca - Lek Pharmaceuticals d.d. - Lonza AG - Martin Christ Gefriertrocknungsanlagen GmbH - Masaryk University - MSD - MSD International - Novartis Global Drug Development / Technical Research & Development - Pensatech Pharma - Pfeiffer Vacuum GmbH - Pfizer - PharmaCept GmbH - Polpharma SA - Rhine Waal University - Sanofi - SCHOTT AG - Shire Austria GmbH now part of Takeda - Surface Measurement Systems Ltd. - Takeda - Tempris GmbH - VLB Berlin - West Pharmaceutical Services Deutschland GmbH & Co KG and others.

Networking

Bram Jongen

Datwyler Pharma Packaging International NV

chaired a panel discussion with speakers from Shire, MSD, Bayer, Martin Christ, Boehringer Ingelheim, Ghent University, Lonza and De Montfort University.