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ISPE Aseptic Conference 2012
Aseptic Technology Applications in Vaccine Manufacturing
Jeff Biskup, Eric Unrau
26.03./27.03.2012
Radisson Blu, Frankfurt, Germany
http://www.ispe.org/2012asepticeuconference
MONDAY, 26 MARCH
Start End
Presentation Title
Time Time
9:00 10:30 Keynote Address(es)
10:45 11:30 Networking Break
11:30 12:30 Keynote Address(es)
12:30 13:30 Lunch
13:30 13:40 Manufacturing and Guidance/Trend Presentation
13:40 14:20 Process Intensification for World Vaccine Delivery
With the process intensification technology this session will explore the possibility of growing more production units (i.e. cells) in the bioreactor. This will decrease the
bioreactor size needed for vaccine production allowing the use of disposable systems. This results in an increased number of batches per year, a reduced facility size,
and decreased cost of goods.
14:20 14:20
14:20 15:00
Guidance/ Trend Presentation
1. QbD for Vaccines; FDA and EMA progress
The presentation will provide an understanding of QbD principles and their potential application to vaccine development by:
• Better understanding of product, process, and different implementation tools and approaches to consider
• Robust and consistent processes with clear understanding of impact of future process changes
• Expedited development and regulatory review
Speaker
(Full Name)
Company
Eric Unrau
CRB
Dr. Emile van Crucell
Corven
Eric Unrau
Dicky
Abraham
CRB
Merck
Total
min.
90
45
75
60
10
40
40
The QbD approaches presented will support the development of the systematic accumulation of product and process understanding that is a major pillar of the vaccine
product life cycle
Recent FDA and ICH guidance has focused on the need to implement quality systems based on relevant data and an enhanced understanding of the manufacturing
process. Companies have initiated work to integrate the concepts of Quality by Design (QbD) into their development and subsequently, demonstrate that they have a
strong understanding of the product’s and the process's characteristics.
The QbD approaches support the development of the systematic accumulation of product and process understanding that is a major pillar of the vaccine product life
cycle. In addition, these efforts will ensure robust and consistent processes, expedited development and facilitate favorable regulatory review.
15:00
15:40
16:20
17:00
17:00
15:40
16:20
17:00
18:30
Networking Break
2. Challenges of Influenza Industry: Introduction of New Manufacturing Technologies for Live Attenuated Influenza Virus
Panel Discussion
Session Adjourns
Welcome Reception
TUESDAY, 27 MARCH
Start End
Presentation Title
Time Time
8:30
8:40
8:40
9:20
Future Vision Presentations: Introduction
1. Future Manufacturing Facility Design for Flexibility
A joint effort of the FDA and Industry created the ISPE Biopharmaceutical Baseline Guide. The concepts of closed processing defined in this joint effort can be utilized to
significantly reduce both facility capital and operational costs. With a closed process:
• The product is not exposed to the room environment providing greater product control and greater regulatory compliance
• The facility detaches from the product protection equation to become an indirect impact system to the product
• Allows for a completely new approach for production facility designs
• Results in a significant reduction in both facility capital and operational costs while providing greater regulatory compliance
This session will benefit individuals and manufacturers responsible for conceptualizing and funding new and retrofitted facilities with the goal of increasing value add and
compliance while decreasing costs.
9:20
10:00
10:00 10:40
10:40 10:50
10:50 11:30
2. Applying Risk-Based Assessments to Vaccine Manufacturing
Networking Break
Solutions to Manufacturing Challenges
1. GMP vs. Containment: How to Manage Conflicting Agendas with Vaccines Facility Design
Modern vaccine production facilities have a number of requirements and challenges that involves conflicts but also synergies due to the main design parameter to assure
product quality and protection of workers and environment at the same time (GMP and Biocontainment/biosafety) At the same time the goal is most often to minimise
and controlling investment costs, prepare for a high level of manufacturing flexibility and sometimes also fast track requests. This session addresses these design drivers
and gives examples of new concepts and facility design for Vaccine facilities with a modular approach.
11:30 12:00
12:00
13:00
13:00
13:45
13:00
13:00
13:45
14:30
14:30 15:00
15:00 15:00
15:00 15:45
2. Gene Therapeutics using Anchorage-Dependent Cell Lines
Several cell lines, which are of current importance for the production of viral vaccines, oncolytic viruses and viral gene therapeutics, are dependent on
surface anchorage. This list includes chicken embryonic fibroblasts (CEF), VERO, MRC-5, WI-38 and A549 cells. Scale-up of adherent cell culture to
industrial/commercial scale is still an issue and most available static mode systems are restricted in their scalability (e.g. cell factories, roller bottles,
hyperflasks). Alternatively, usage of micro-carriers (e.g. Cytodex) is in principle scalable, however, bead-to-bead transfer is still challenging. Other
options for large scale adherent cell culture include hollow-fiber perfusion systems which in general are complicate to operate. Here we describe the
evaluation of a novel and innovative, fully scalable, disposable, fixed-bed bioreactor system (iCELLis™, ATMI) for virus/vaccine production. In this
system, cells grow on macro-carriers made from medical-grade polyethylene-terephtalate (PET), which are contained within the fixed-bed. Constant
enrichment of the medium with oxygen is obtained through the proprietary principle of “waterfall oxygenation”. Data for production of a model
Paramyxovirus on VERO cells and preliminary growth data with A549 cells, which is the cell line of choice for the production of Oncolytic Adenoviruses,
are presented.
Lunch
Solutions to Manufacturing Challenges
3. Single Use Systems vs. Stainless Steel Bioprocess Manufacturing
4. Integrated E-Plant Concept for Lean Biopharmaceutical Production
An overview of electronic plant concepts for lean production of biopharmaceuticals including:
• integration of electronic systems throughout the production, supply chain and laboratories (MES, Automation, ERP)
• potentials to leverage e-plant for continuous improvement
• 2 essential parts need to go together - enabling systems and improvement culture
• case study from Merck Serono's site expansion in Vevey, Switzerland
Networking Break
Solutions to Manufacturing Challenges
5. The Role of CMO's in Supporting Global Vaccine Production Needs; Case Study- Brazil Fill Finish w/ single use
A case study presentation on the design for a greenfield vaccine manufacturing plant in Brazil.
Objectives:
• The benefit of utilizing emerging economies to supply the global need for vaccines.
• An understanding of how the latest industry trends and technology are being utilized to manufacture vaccines.
• An understanding of the Process Architectural design process.
15:45 16:30
6. ISPE Sterile Guide Overview
16:30 17:00
17:00
Panel Discussion: Sharing solutions and Experiences in Vaccine Manufacturing
Session Adjourns
40
Carl Jones
MedImmune 40
All Speakers
40
90
Speaker
(Full Name)
Company
Total
min.
Eric Unrau
Mark von
Stwolinski,
AIA
CRB
CRB
10
40
Marc
Pelletier
CRB
40
Eric Unrau
Henriette
Schubert
30
CRB
10
NNE
40
Pharmaplan
Dr. Kai
Lipinski
Vibalogics
Eric Unrau
Invited
Dr. Dirk
Böhm
CRB
Sartońus
Merck
Serono SA
Eric Unrau
CRB
Rob Roy, PE IPS
Jason Collins
Mark von
CRB
Stwolinski,
AIA
All Speakers
30
60
0
45
45
30
5
45
30
30