GMP/GDP Compliant Facilities & Technology

Objective

The focus of this conference is on innovative investment projects and their GMP-compliant, technical realisation.

Background

State-of-the-art greenfield, brownfield and pharmaceutical technology projects will be presented by the “pharmaceutical user” under the motto "Users report for users".
Compliance with GMP requirements is mandatory in these projects, although those are usually described in little detail in guidelines from authorities. Benchmarking with other companies in the pharmaceutical industry is all the more important here in order to derive the current state of the art.

Target Audience

The target group of the conference are specialists and managers from the areas of technology and production, as well as representatives of pharmaceutical plant construction and from engineering companies.

It particularly addresses the departments:

  • Production
  • Engineering / Technology

Moderator

Dr Johannes Krämer, CSL Behring

Programme Download

Please click on the programme image to download the programme as PDF.

Registration

To register for the conference, please see the registration options.

Detailed Programme

Presentations - 31 May 2022

The Large Scale Cell Culture Program
Thomas Zlabinger, Boehringer Ingelheim

  • Introducing Boehringer Ingelheim and the LSCC program
  • Challenges during the project this sizes
  • Deep dive: Commissioning and Qualification strategies

Boehringer Ingelheim in Vienna, Austria has opened its LSCC building (Large Scale Cell Culture) in October 2021 to further strengthen its biopharmaceutical product portfolio. To date, the LSCC is the largest single investment the company has ever made.

IDT Biologika: Design & Implementation of new flexible (modular) Vaccine Production Facility
Dr Daniel Minör, IDT Biologika
Dirk Steinhäuser, Glatt Ingenieurtechnik

IDT Biologika has extended its biotech CMO capacity for vaccines at its Dessau site in Germany with a new, very flexible biotech facility. The case study will provide an overview on the project development from initiation phase, via Concept Design and all Engineering phases, fast-track modular building construction, implementation of HVAC, cleanrooms, biotech equipment for upstream and downstream processing, media and buffer systems and further necessary periphery. Specific requirements for a multi-purpose vaccine production facility will be outlined. Further key points are:

  • Production of virus vaccines, including cancer vaccines
  • Biosafety level 2 and cleanroom class B design, implementation and operation
  • Attention points of single-use equipment and application
  • Fast track modular building using concrete steel prefab systems
  • Supply chain management for single use material in pandemic environment

Merz: Investment in Dessau
Björn Niemczak, Merz Pharma

CSL Behring: Challenges due to limited Space in the existing Building during Construction Phase
Matthias Klein, CSL Behring
Steffen Mörler, CSL Behring

The ILC-H69 (Increase Lyophilization capacity – building H69) project involves the installation of two new freeze dryers with automatic vial loading system and connection to existing filling line. The special challenges of this project are the extremely limited space in the existing building and the continuation of filling operations during the construction phase. These were mastered with the use of new planning tools.

  • 3D Planning
  • Laserscan
  • Virtual Reality visualization
  • Feasibility Study for large component intake

Microwave-assisted freeze-drying of Biologicals
Nicole Härdter, Ludwig-Maximilians-Universität München

  • Basic principles of microwave-assisted freeze-drying
  • Experimental design
  • Critical quality attributes of the lyophilizates
  • Stability studies

Vetter Pharma: Integration of an existing pharmaceutical Manufacturing Site into Vetter’s Development Services
Dr Martin Schwab, Site Manager Vetter Development Services, Austria

  • Site acquisition,
  • Technical and regulatory assessment
  • Strategic approach,
  • Technical adaptions
  • Process optimization

In July 2020 an acquisition contract has been signed by Vetter’s general management. This contract absorbed the former commercial and clinical manufacturing site in Rankweil, which was planned, built and operated until Q4 2019 by Rentschler, into Vetter’s company structure. Aim of this acquisition was to support Vetter’s growing clinical manufacturing business and to establish Rankweil as an additional dedicated clinical manufacturing site - analogous to the clinical manufacturing site in Skokie, USA. For this buildup, including several technical and structural adaptions, an ambitious project has been established with its main milestone, the inspection of the Austrian authorities, planned and accomplished less than 1.5 years after the signature of the acquisition contract.

Novo Nordisk: Closed Systems in CNC Ballroom, A Risk Based Approach
Lars Hovmand-Lyster, Novo Nordisk

Harmonization and evaluation of appropriate room classification requirements across the biopharmaceutical industry A risk based approach to assigning appropriate room classification to operations during facility design Enabling pharmaceutical industry to move operations to a more flexible facility whilst reducing both operational and capital costs Impact of closed systems and ballroom design on facility design, construction and qualification.
Ultimately increasing speed to market and reducing cost of goods to patient For closed systems increasing room classification has no increase in product safety and in reality has a negative impact.

Presentations - 1 June 2022

Merck's new modular GMP Plant for clinical DP Manufacturing
Dr Markus Weigandt, Merck Healthcare

Overview of Merck's modular approach to cover the Drug Product GMP supply of the early healthcare pipeline:

  • Products possible up to OEB5
  • Manufacture of orals solid dosage forms and parenterals
  • Small technical and operational footprint : flexible setup enables a broad technology base
  • Qualification strategy
  • Lessons learned

Boehringer Ingelheim: New solid launch Facility for Containment
Volker Glück, Boehringer Ingelheim
Ilka Rudzio-von Arx, Pharmaplan

In this presentation the new solid launch facility of Boehringer Ingelheim in Ingelheim for the production of launch products with OEB Level 4 with containment technology will be shown.

  • Overview of main data of the project
  • Containment strategy
  • Layout considerations for OEB Level 4
  • Solutions for containment

Implementation of cold WFI systems in Europe
Markus Multhauf, ECA Validation Group

  • Current technical developments
  • Regulatory issues

Roche: CAPEX Project Delivery for What Patients Need Now
John Honey, Roche
Alois Probst, Roche

The COVID-19 pandemic triggered a significant demand for Diagnostics Operations. Several “Fast Track” projects were initiated to install additional capacity in order to meet the immediate demand. The classical milestone approach to project execution would not deliver capacity in time so alternative strategies were employed. Just in time planning, overlapping of project phases, transparent and collaborative communication supporting funding approval, long lead item ordering at risk, etc.

Road from Design, Commissioning, Qualification to Process Validation for Fast tracked Projects
Udara Yapa, WuXi Biololgics

Overview of common pitfalls that happens during fast tracked projects and potential solutions to overcome these pitfalls. Following stages will be explored:

  • Purchasing and negotiation
  • Design Qualification
  • Commissioning and Qualification
  • Handover to the user
  • Time loss between end of OQ till start of PV
  • Constraints during transition from PV to a routine manufacturing

Aseptic Sterile Filtration using Single Use and Isolator Technologies
Nicola Rutigliani, Merck

  • Project: facility and equipment pre-requisites, qualifi cation and implementation of SUS
  • Risk identification when using SUT and mitigation strategy
  • SU integrity test at the point of use (method development & qualification)

FUJIFILM Diosynth Biotechnologies CDMO: Multifunctional Single-Use Purification System for connected and integrated Continuous Processing
Dave Mills, GEMÜ
Dr Charles Heise, Fujifilm

  • Tangential Flow Filtration
  • Protein A affinity chromatography
  • Viral Inactivation
  • Cation and anion exchange chromatography
  • Viral Filtration
  • Ultrafiltration/Diafiltration
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