Pharmaceutical Lyophilization Summit 2019 - Kongress / Konferenz von Qepler s.r.o.

Discuss best practices in tech & regulatory updates, process, formulation, testing, monitoring and new products development.

Inhalte

CONFERENCE OVERVIEW:

Although lyophilization is an old process, it remains to be complex. Today we 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 best practice in technical and regulatory updates, manufacturing and process development, freeze-dried formulation, testing and monitoring of new products development.

CONFERENCE PROGRAM:

Day 1st | Wednesday, 13 February 2019

07:50 -   Registration and Welcome Coffee 08:30 -   Opening Address from the Chairman

PART 1: REGULATORY ASPECTS & CONSIDERATIONS

08:40 -   Pharmaceutical Quality System (PQS).

  • Regulatory Requirements & Background
  • Process Centred Design
  • Quality Culture
  • Knowledge & Change Management
  • Process Change

Jaap Koster CEO / Senior Consultant -  PCS Pharmaceutical Consultancy Services Netherlands

09:20 -   Speed ​​Networking

PART 2: MANUFACTURING & PROCESS DEVELOPMENT

10:00 -  Evaluation of innovative spray freeze drying method and comparison to standard lyophilization.

  • Introduction and application examples
  • Case study for pharmaceutical development
  • Pro’s and Con’s of each technology, Outlook

Stefan SchneidLaboratory Head Formulation Development Parenterals - BayerGermany

10:40 -  Morning coffee and networking break

11:10 - Latest developments in MTM.

Georg FrinkeFacility & Process Engineer - Bayer PharmaceuticalsGermany

11:50 - Impedance Spectroscopy: Recent Developments as a Process Analytical Technology for Pharmaceutical Freeze-Drying.

  • Impedance spectroscopy for beginners
  • Through Vial Impedance Spectroscopy (TVIS)
  • Applications: (i) ice nucleation; (ii) 1° drying rate; (iii) product temperatures; (iv) Kv and Rp determination
  • Accelerated design space assessment

Prof. Geoff SmithProfessor of Pharmaceutical Process Analytical Technology - De Montfort UniversityUnited Kingdom

12:30 -  Business lunch

13:30 - Freeze-Drying of High Concentration Biologics.

  • What are high concentration biologics?
  • CMC issues for high concentrated biologics
  • Challenges encountered for freeze drying thereof

Patrick GaridelHead of Process, Purification and Pharma Development, Biopharma - Boehringer IngelheimGermany

14:10 - Lyo cycle development.

Michael DeknerHead Fill&Finish Life Cycle Management support - Shire, Austria

14:50 -  Afternoon coffee and networking break

15:20 - Anatomy of the Lyophilization Process: Considerations for a Successful Tech Transfer.

  • Tech transfer of a lyophilized product
  • Overview of the lyophilization process and the critical process parameters
  • Specific focus on the technical considerations with analysis of the impact on the lyophilization recipe
  • Impact of deviations to the CPPs on the product quality during transfer activities

Anthony CannonRegional Director, ExM, Global Tech Ops, Sterile - MSD International, Switzerland

16:00 - Scale-Up, Process Transfer and Improving Predictive Outcome for Lyophilized Drug Product.

  • Key considerations in Scale-up of a Freeze-Drying Cycle
  • Review of advancements in the Industry over the last 15 years
  • Case Study: ‘Development Scale to Pilot Scale and Beyond’

Orla McGarveyPrincipal Group Leader, Drug Product Process Development - Lonza AGSpain

16:40 - A Continuous and Controlled Pharmaceutical Freeze-Drying Technology for Unit Doses.

Driven by growing needs in the biopharmaceutical market and regulatory pressure, a continuous and controlled freeze-drying technology for unit doses to preserve biopharmaceuticals has been developed. Such continuous process allows a more efficient, cheaper, greener and controllable manufacturing method compared to traditional batch production systems, offering competitive advantages and business opportunities. Pharmaceutical freeze-drying (lyophilization) is a low-temperature drying process in which aqueous solutions of heat-labile biopharmaceuticals are converted into solids with sufficient stability for distribution and storage. Similar to all manufacturing processes of drug products (solids, semi-solids and liquids), conventional pharmaceutical freeze-drying is generally accomplished using batch processing that is considered time-consuming, costly, non-flexible and lacking robust quality control and real-time release. Four major industrial drivers are demanding a more efficient and better controllable pharmaceutical freeze-drying technology for unit doses: costcutting, regulatory pressure, a fast growing biopharmaceutical market and an ageing population requiring more personalized medicines. The continuous and controlled freeze-drying technology, developed following the principle of model based design, offers clear advantages over current batch production such as cost reduction (up to 50%), track-and-trace product quality control, and a significant reduction of processing time (> 40 times faster, e.g. 1 hour instead of 5 days at a vial level), reduced need for clean room and a substantial sustainability gain.

Thomas De BeerProfessor - Ghent University, Belgium

17:20 - Panel Discussion

17:50 - Chairman's closing remarks and end of day one19:00 - Business dinner

 

Day 2nd | Thursday, 14 February 2019

08:00 -  Registration and Welcome Coffee08:40 -  Opening Address from the Chairman

PART 3: MANUFACTURING & PROCESS DEVELOPMENT

08:50 - Inactivated Zika virus vaccine – fast track drug product development – formulation and lyophilization design space study.

The Zika virus (ZIKV) epidemic which occurred throughout Latin America, led The World Health Organization (WHO) to declare a Public Health Emergency of International Concern (PEIC) in February 2016. An inactivated Zika vaccine, developed by the Walter Reed Army Institute of Research, was found to be protective in animal models. This vaccine was transferred to Sanofi Pasteur where the viral seed was regenerated in serum-free Vero cells and process development was carried out to produce material to be used for further pre-clinical and clinical evaluation. The case study reported here focuses on the fast track drug product development with a strategy driven by a process/ product risk analysis to support the selection of the appropriate stabilizing formulation and freeze-drying process. Finally a Design of experiment approach is presented where the combination effect of formulation and lyophilization parameters are assessed in a design space study.

Florent PeralFormulation Scientist - Bioprocess R&D - Sanofi Pasteur, France

09:30 - Use of in silico methods to study freeze drying.

Mire ZlohHonorary Professor - UCL School of PharmacyUnited Kingdom

10:10 -  Morning coffee and networking break

PART 4: TESTING & MONITORING

10:40 - Container Closure Integrity Testing using deterministic techniques like He-leak.

  • Revision of USP , ‘Sterile Product Packaging – Integrity Evaluation’
  • Highlights of the different test methodologies
  • He-leak & Laser Based Headspace Analysis techniques

Bram Jongen Head of R&D, PPS - Datwyler Pharma Packaging International NVBelgium

11:20 - Workshop: Lyophilisation equipment and freeze drying process.

Yossi Shapira Assoc Director, MS&T S.M.E, Laboratories, Containment, Lyophilization technologies - Teva PharmaceuticalsIsrael

12:20 -  Business lunch

PART 5: SAFETY & RISKS MITIGATION

13:20 - GMP and Occupational Safety Requirements for Lyophilization of high potent/toxic substances.

  • What are high potent/toxic substances
  • GMP Requirements for high potent/toxic substances
  • Cleaning and Cross Contamination Requirements for Lyophilization based on the PDE (Permitted Daily Exposure)
  • Occupational Safety Requirements

Richard Denk Head of Sales Containment - Skan AGGermany

13:20 - Lyophilization: Silicon oil contamination risk and mitigation strategies.

  • Silicone oil in the freeze-drying process
  • Mass spectroscopy
  • Case study Silicon oil leakage
  • Detection
  • Remediation
  • Learnings and improvements

Martin Frei Process expert, Novartis Technical Operations - NovartisSwitzerland

14:40 -  Afternoon coffee and networking break

PART 6: INNOVATIONS & ADVANCED TECHNOLOGIES

15:10 - Smart rubber stopper selection for Lyophilization.

  • Selection of a rubber stopper design intended for lyophilisation purposes
  • Reduction of stopper stickiness to lyophilisation shelves
  • Effect of the rubber formulation on moisture content
  • Low moisture rubber formulations and effect on the freeze-dried cake, combining different methods

Bram Jongen Head of R&D, PPS - Datwyler Pharma Packaging International NV, Belgium

16:40 - A Continuous and Controlled Pharmaceutical Freeze-Drying Technology for Unit Doses.

Driven by growing needs in the biopharmaceutical market and regulatory pressure, a continuous and controlled freeze-drying technology for unit doses to preserve biopharmaceuticals has been developed. Such continuous process allows a more efficient, cheaper, greener and controllable manufacturing method compared to traditional batch production systems, offering competitive advantages and business opportunities. Pharmaceutical freeze-drying (lyophilization) is a low-temperature drying process in which aqueous solutions of heat-labile biopharmaceuticals are converted into solids with sufficient stability for distribution and storage. Similar to all manufacturing processes of drug products (solids, semi-solids and liquids), conventional pharmaceutical freeze-drying is generally accomplished using batch processing that is considered time-consuming, costly, non-flexible and lacking robust quality control and real-time release. Four major industrial drivers are demanding a more efficient and better controllable pharmaceutical freeze-drying technology for unit doses: costcutting, regulatory pressure, a fast growing biopharmaceutical market and an ageing population requiring more personalized medicines. The continuous and controlled freeze-drying technology, developed following the principle of model based design, offers clear advantages over current batch production such as cost reduction (up to 50%), track-and-trace product quality control, and a significant reduction of processing time (> 40 times faster, e.g. 1 hour instead of 5 days at a vial level), reduced need for clean room and a substantial sustainability gain.

Thomas De Beer  Professor - Ghent UniversityBelgium

16:30 -  Panel Discussion 17:00 -  Chairman's closing remarks and end of summit

Lernziele

THE FEATURED TALKS ON:

  • Latest regulatory updates in lyophilization. Preparation for the regulatory review and inspection.
  • Lyophilization process development. Process optimization, monitoring, and control. Model-based process engineering.
  • Risk-based approaches to the design and development of drug delivery systems
  • Lyophilization cycle development, optimization 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 effects on the formulations.
  • New methods to evaluate the 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.
  • Lyophilization 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.

Zielgruppen

DIVISIONS:

  • lyophilization
  • Pharmaceutical Manufacturing, Engineering & New Technologies
  • Laboratory Management
  • R & D
  • Formulation
  • containment
  • Pharmaceutical & Processing Development
  • Process Design, Technology, Analytics, Testing, Monitoring & Control
  • Aseptic Production, Cleaning & Sterilization
  • Bioprocessing
  • QA / QC
  • Characterization
  • Packaging & Labeling
  • Risk Management
  • Regulatory Affairs
  • Stability
  • Standardization
  • Qualification & Validation
  • Scale-up & Technology Transfer
  • Cycle management
  • Facility & Site Design & Management
  • PAT, QbD
  • Media Fills
  • Visual Inspection
  • Filling & Materials
  • Materials Development
  • Container Development & Container Closures
  • Vials, Stoppers & Dual Chamber Systems
  • Devices & Application Systems
  • Product Development & Control
  • Parenteral Production
  • Injection Systems
  • Vaccines
  • Corporate & Business Development
  • External supply
  • Sales & Marketing
  • outsourcing
  • Partnerships & Alliances
  • Sales Development
  • Strategic Development

 

COMPANY TYPES:

  • Pharmaceutical
  • Biotechnology
  • Chemical
  • Medical Devices
  • CDMOs
  • CMOs
  • CROs
  • NOPs
  • Regulatory agencies
  • Bioprocessing services and equipment
  • Equipment suppliers
  • Training providers

SG-Seminar-Nr.: 5210003

Anbieter-Seminar-Nr.: qlyo19

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