8:45 a.m. – 10:30 a.m.
Opening Plenary Session
Moderator:  Maik Jornitz, Chief Operating Officer, G-Gon, LLC, Co-Chair, Program Planning Committee

Session Description: PDA's membership is based on pharmaceutical and biopharmaceutical drug developers and manufacturers, which comply with global regulations to supply safe and efficacious sterile products. To support these efforts, PDA fosters networking, educational and communication opportunities, which bring peer companies, consultants and regulators together to learn, inform and improve.

8:45 a.m. – 9:30 a.m.
Affordable Healthcare Act and the Impact on Industry
David Cutler, PhD, Otto Eckstein Professor, Applied Economics, Harvard University

9:30 a.m. – 10:15 a.m.
A Journey of Hope & Survival
Joyce Bloomfield, Executive Director, Global GMP Systems & Compliance, Merck Sharp & Dohme

10:15 a.m. – 10:30 a.m.
Q&A

Formulation, Optimization, and Evaluation of Aspirin Oral Disintegrating Tablets, Prepared from Direct Compression Method
Abhishek Agrawal, Research Student, Campbell University

Stoppering Prefilled Syringes: Protecting Drug Product from Silicone Oil, Air Bubbles and the Environment
Ge Bai, PhD, Scientist, MedImmune, LLC

Application of Optical Fluorescence for Real Time Cleanrooms Microbiological Air Monitoring
Gilberto Dalmaso, PhD, Global Aseptic Processes Development Manager, Particle Measuring Systems

Optimization and Scale Up of a Lyophilization Cycle to Target a Specific Moisture Content in a Biopharmaceutical Product
Sarah Eccleston, PhD, Head of Development, Aptuit

Effect of Processing Parameters on Bacterial Retention with a Spirochete Challenge Microorganism
Lia Jeffrey, Microbiological Scientist III, EMD Millipore

Comparison of Flange Strength and Dimensional Variability in 1mL Long Syringe Systems Made of Plastic and Glass
Harold Murray, Project Engineer, West Pharmaceutical Services

Novel Plastic Bag Container for Monoclonal Antibody Final Bulk Storage to Prevent Oxidation
Hiroo Nakano, PhD, Scientist, R&D, Hosokawa Yoko Co., Ltd.

Glass-Replacement Vial and Syringe with Oxygen Absorbing Resin
Shun Ogawa, Senior Researcher, Next Generation Business Project Group, Mitsubishi Gas Chemical Company, Inc.

Impact of a Customized MALDI-TOF Library for Environmental Microbial Identifications
Anne Russell, PhD, Senior Staff Scientist, Charles River Laboratories

Analysis of the Sterility Test Sample Size in Positron Emission Tomography (PET) Drug Manufacturing
Eric Webster, Biomarker Development Manager, PETNET Solutions

Challenges of Complex Process Development Using Advanced Sterile Manufacturing
Waiken Wong, PhD, Development Engineer,  Catalent Pharma Solutions

Description:
Pharmaceuticals from genetically modified plants are now at the cusp of reaching the market. This session addresses the scientific, technical and commercial manufacturing aspects of plant-based production systems, with emphasis on quality and regulatory challenges. The first presentation will cover therapeutic protein production in plants using transient expression systems. These systems have been scaled up to commercial production in capacities exceeding 400 kg/year of finished protein product in high containment facilities. A case study will be presented highlighting the development of a large plant-made pharmaceuticals facility in conjunction with the Defense Advanced Research Projects Agency  (DARPA), designed for rapid response to a pandemic or biological threat. The second presentation will provide an overview of the development of a genetically engineered carrot cell based manufacturing platform from its earliest days through to an approved therapy for treating Gaucher disease.  The presentation will describe some of the development process in bringing this product to market and briefly touch on the company’s pipeline.

Description:
Future facility requirements asked for flexibility in regard to capacity variations, multi-product production and potential mobility. Furthermore, more robust containment solutions within facilities or as facilities are necessary to fulfill regulatory needs and protection of the environment. The session will cover both topics in detail.
Flexible modular system will be described in regard to the functionality of either being a unit operation or utilized as assembled product site. Example cases will show the benefits of these modular pods for start-up companies, failed product approval, multi-product or varying capacity production sites.

Description:
Practices and expectations continue to evolve in process validation.  This session will focus on two new challenges in process validation, single use systems and Continued Process Verification (CPV).  For single use, the presentation will first review the advantages of this technology as it applies to manufacturing.  Based on these drivers, a strategy for the qualification / validation of a single use system will be presented, including the challenges that need to be addressed during execution.   The session will continue with the challenges of implementing a Continued Process Verification program, aligned with the 2011 FDA guidance on process validation.  Applying statistical process control following a standard "text book" approach results in several common real life issues during execution of the CPV program.   The presentation will offer some practical solutions to overcome these issues during implementation.

11:15 a.m. – 11:45 a.m.
Transient Expression and Commercial Production of Therapeutic Protein in Plants

Barry Holtz, PhD, Chief Science and Technology Officer, Caliber Biotherapeutics

11:15 a.m. – 11:45 a.m.
New Modular Production Facilities

Maik Jornitz, Chief Operating Officer, G-Con Manufacturing, LLC

11:15 a.m. – 11:45 a.m
Qualification / Validation of Single Use Systems

Christopher J. Smalley, PhD, Director, Merck Sharp & Dohme

11:45 a.m. – 12:15 p.m.
Elelyso – First – In – Class, Approved Recombinant Drug Produced from Plant Cells

Karen Ginsbury, CEO, PCI Pharmaceutical Consulting Israel, Ltd.

11:45 a.m. – 12:15 p.m.
Cytotoxic Dedicated Facilities

Hank Rahe, Technical Director, Enguard Systems

11:45 a.m. – 12:15 p.m.
Statistical Issues in Continued Process Verification

Julia O’Neill, Director, Principal Engineer, Merck & Company, Inc.

12:15 p.m. – 12:45 p.m.
Q&A

Description:
The type of expression system a product has is responsible for a wide range of considerations from manufacturing capacity to patient safety profiles.  Significant development efforts have achieved breakthroughs and enhancements of our utilization of expressions systems for the manufacturing of biopharmaceutical products.  This session explores the current state of expression system development in regards to two innovative areas, specifically, microbial cultures and the application of cell culture in vaccine manufacturing, including the elusive cell culture based Influenza vaccine.

Description:  
New products, complex delivery systems, and modern processing technologies create the opportunity and need for innovative approaches to sterile product packaging.   In this session, industry experts will discuss current container/closure issues and explore alternative approaches, including case studies and on-going activities, design to meeting these challenges.

Description:
Most companies operate in a global environment, which represents a challenge when it comes to compliance.  This session will provide you with alternatives to comply with global market requirements for product traceability using serialization and barcoding techniques.  In addition we will explore microbiological applications that can lower your operation cost of controlled environments.  This session is designed to provide the audience with innovative approaches with potentially cost savings opportunities while remaining compliant in a global environment.

2:15 p.m. – 2:45 p.m.
Advances in Influenza Vaccines: Cell Culture and Beyond

Fred Porter, PhD, Head of Viral Drug Substance Research and Development, Novartis Vaccines and Diagnostics

2:15 p.m. – 2:45 p.m.
Plastic Container Development for Biological Parenterals

Rob Swift, Senior Principal Engineer, Amgen, Inc.

2:15 p.m. – 2:45 p.m.
Serialization and Bar Coding

Cyndi Poetker, Sr. Program Manager of Global Standards and Serilization, Abbott Laboratories

2:45 p.m. – 3:15 p.m.
Efficient Production of Antibody Fragments in Microbial Cell Culture

Peter Steiner, PhD, Head Production and Processes, ESBATech, a Novartis Company

2:45 p.m. – 3:15 p.m.
Closed Vial/ Container Aerosol Bioburden Challenge

Andreas Toba, PhD, Senior Micorbiology, Microbiology Laboratory, Medical Instill Technologies, Inc.

2:45 p.m. – 3:15 p.m.
Multiple Applications Using A Rapid Microbiology System Including Cost Saving Opportunities

Peter Noverini, Field Application Scientist, BioVigilant Systems, Inc.

Miguel Nogueras, PhD, Global Manager, QA, Microbiology, Abbott Medical Optics (AMO)

IG1
Quality Risk Management

Leader:
Michael A. Long, PhD, Director and Principal Consultant, ValSource, LLC

Description:
This year’s IG session will open with a presentation by Dr. Michael Long entitled The Impact of Heuristics and Biases in Risk Management.  Heuristics play an important role in risk management, and executing risk assessments.  These cognitive behaviors impact and govern decision making and judgments regarding risk. They are also a significant source of error and bias in our decision making. During this session, common heuristics will be explained and tools will be discussed to assist in minimizing their impact on risk assessments.

Following this presentation, Jeffrey Hartman will facilitate a discussion on the recent PIC/S Aide-Memoire, Assessment of Quality Risk Management Implementation.  This guidance document was published in March 2012.  Together, we will review the five questions posted in the Aide Memoire and collectively determine how effective and well integrated Quality Risk Management is in our companies and industry.

IG2
Biotechnology

Leader:
Georg Roessling, PhD, Senior Vice President, PDA Europe

Description:
The Biotech Interest group will focus on current opportunities and challenges in cellular and gene therapy. The interest group will present an update on the current efforts of the PDA Task Force on Cellular and Gene Therapy. The session will also present the findings of the PDA survey on Bioburden and Biofilm Management along with an update on the status of the Bioburden and Biofilm Management technical report.

Speakers:

Michael VanDerWerf, Director, Regulatory CMC, GlaxoSmithKline Biologicals SAS

Alice Varga, Vice President, OXiGENE

Georg Roessling, Senior Vice President, PDA Europe

IG3
Management on Outsourced Operations

Leader: 
Karen Ginsbury, CEO, PCI Pharmaceutical Consulting Israel, Ltd.

Sue Schniepp,Vice President, Quality and Regulatory Affairs,
Allergy Laboratories, Inc.

Description:
This interest group is devoted to discussing issues and concerns of contract organizations.
The inaugural meeting of this group took place at the PDA/FDA Joint Regulatory Conference in 2012.
This second meeting will be a continuation of the initial discussion and will focus on some of the “hot topics” identified by the participants.

There will be a presentation on Effectively Handling Audits and Quality Agreements.

IG4
Microbiology/Environmental Monitoring

Leader:
Jeanne E. Moldenhauer, Vice President, Excellent Pharma Consulting, Inc.

Description:
This year we will be talking about some of the changing expectations for media fills.  In recent months there have been many new requests from investigators regarding media fills.  A panel of subject matter experts will be present to discuss some of these new expectations and how we might respond.

Speakers:

Hal Baseman, Chief Operating Officer, Valsource, LLC

IG5
Pre-filled Syringes

Leader:
Thomas Schoenknecht, PhD, Director, Global Key Accounts Management, Schott AG

Description: 
This session will focus on methods and process ensuring container closure integrity on syringes and drug delivery devices.

Speakers:

Justin Wright, Director, Pharmaceutical Development, BD Medical – Pharmaceutical Systems
Akshay Kamdar, Associate Senior Consultant Engineer, Eli Lilly Italia S.P.A.
Rob Swift, Senior Principal Engineer, Amgen, Inc.
James Nadlonek, Sales Manager, Bausch & Stoebel Machine Co.

IG6
Facilities and Engineering

Leader:
Christopher Smalley, PhD, Associate Director, BioSterile Validation, Merck Sharp & Dohme

Description:
Do More With Less.  How often have we heard that mantra, and how often will the burden fall to the Facilities and Engineering Group to make it happen?

At this session, we will recap some of the earlier presentations on energy conservation, 'Green' energy, use of Single Use Systems, and disposal of Single Use Systems with a focus on the growth of Single Use Systems as a means to improve manufacturing flexibility and reduce water usage and waste.  Learn how to 'Do More With Less.'

IG7
Sterile Processing and Inspection Trends

Leader: 
Ken H. Muhvich, PhD, Principal Consultant, Micro-Reliance, LLC

Bob Dana, Senior Vice President Quality and Regulatory Affairs and PDA Training and Research Institute, PDA

Description: 
The manufacture of sterile products continues to receive a great deal of attention during regulatory inspections.  This Interest Group session will review some of the most important points to consider in preparing for regulatory inspections, and provide an overview of a general inspection plan.

Significant findings arising from regulatory inspections will also be presented and discussed.

8:30 a.m. – 10:00 a.m.
Plenary Session 2 – Major Changes to the Industry

8:30 a.m. – 9:00 a.m.
Drug Shortages
Marty Nealey, Vice President, Operations, Plant Manager, Hospira Pharmaceuticals, Inc.   
9:00 a.m. – 9:30 a.m.

Counterfeiting
Martin VanTrieste, Senior Vice President, Quality, Amgen, Inc.

9:30 a.m. – 10:00 a.m.
Q&A

Simplifying and Standardizing Single-use Storage Bag Designs
Susan Ashley, PhD, Senior Specialist, Engineering, Merck & Company, Inc.

Container Closure Integrity of Rubber-stoppered Glass and Plastic Vials Stored at -80°C and in Dry Ice
Patrick Curran, Associate Process Engineer, West Pharmaceutical Services

Enhanced Isolator Aeration Design to Achieve Low Levels of H2O2 Vapor
Jim Vogel, Technical Consultant, METALL + PLASTIC (On behalf of Don Eddington)

Validation of and Corporate Value from Automation of Environmental Monitoring Test Methods
David Jones, PhD, Technical Services Director, Rapid Micro Biosystems

100% Container Closure Integrity Testing of Lyophilized Drug Products by the Oxygen Head Space Analysis Methodology – Determination of Minimum Hold Times for Detection of Blue Dye / Microbial Ingress Leak Rates
Fred Lim, Principal Engineer, Pharmaceutical Processing and Technology Development, Genentech, Inc.

Case Study: Implementation of a Pilot-Scale Bulking Process with Single-Use Systems for Production of Biological Entities
Daniel Rauer, Development Scientist, Bayer Healthcare

Challenges in Clinical Manufacturing and State-of-the-Art Approaches
Susanne Resatz, Manager Process Development and Manufacturing, Vetter Pharma International GmbH

Pushing the Limits: Defining the Concepts of Minimum Detection Limits in a Microbial Cell Bank Contamination Event
Jaspreet Sidhu, PhD, Vice President, Pharmaceutical Microbiology, Molecular Epidemiology, Inc.

Implementing a Robust Supplier Initiated Change Program
Shawn Smith, Manager, MedImmune, LLC

Survey of Pharmaceutical Manufacturers using 100% Headspace Inspection
James Veale, PhD, President, Lighthouse Instruments

Case Study of Single-Use Mixer and Stainless Steel Vessel for Media Formulation
Be Vu, Engineer, Merck Sharp and Dohme

Suppliers of ready-to-use components such as sterilized containers/closures, stoppers, single-use bags must be treated with the same level as your most critical process even if full GMP are not required at their manufacturing process. Focus must be placed on the sterilization process and the testing/validation of such.

10:45 a.m. – 11:15 a.m.
A/VAX, CMC Vaccine Working Group QbD

John Finkbohner, PhD, Senior Director, Regulatory Affairs, MedImmune, LLC

10:45 a.m. – 11:15 a.m.
Advanced Sterilization Techniques

Patrick McCormick, PhD, Manager, Research Sterilization, Bausch & Lomb, Inc.

10:45 a.m. – 11:15 a.m.
Outsourcing Contract Facilities Manufacturing

Ian Elvins, Vice President, Quality, Lonza Biologics

11:15 a.m. – 11:45 a.m.
Case Study: QbD Implementation for Vaccines

Cristiana Campa, PhD
Manager, Technical Development, Novartis Vaccines and Diagnostics

11:15 a.m. – 11:45 a.m.
Advancements in Aseptic Processing:  Isolators & RABS

James Akers, PhD, President, Akers Kennedy & Associates

11:15 a.m. – 11:45 a.m.
Ready-to-Sterile and Ready-to-Use Components

Edwin Rivera-Martinez, Vice President, U.S. Quality Liaison, Global Quality, Sanofi-Aventis

11:45 a.m. – 12:15 p.m.
Q&A

Description:
Biotechnological and biological therapeutic products are often manufactured using materials of animal or human origin and the risk of contamination by known or unknown pathogens exists. Regulatory agencies worldwide require a demonstration of viral safety for these products. This session will address virus-removal filters, which are specifically designed to remove viruses and other biomolecules. Virus filtration is a complement to virus inactivation, both of which contribute to virus clearance. 

In addition, the session will include principles and practical applications for the preparation and testing of high quality virus spikes. There will be a discussion of the quality attributes that need to be tested and controlled in virus spikes so that they can be used in representative scale down validation studies.

Finally, this session will address concepts to consider when implementing a Single Use System (SUS) strategy in a pharmaceutical manufacturing process.  A comparison will be made of single use technology over multi-use technology in determining the most appropriate manufacturing strategy, and the potential impact of a SUS on product quality will be discussed

Description:
This session will cover two important elements impacting the quality of finished pharmaceutical products.  Process equipment used to manufacture pharmaceutical products intended to be sterile must be properly cleaned and sanitized or sterilized prior to use.   This session will address the technology associated with steaming of process equipment, including the design and validation of steam in place cycles.  A second presentation will address the important concepts associated with visually inspecting each container of finished drug product to ensure the absence of visible particulates and cosmetic defects.

Description:
An emerging trend has been occurring in process validation in the past few years.   A new draft regulatory guidance on process validation has been issued by the EMA (European Medicines Agency) and comments were due October 2012.  The FDA finalized their guidance in January 2011.   A comparison of the traditional and continuous process verification approaches to process validation will be described.  The similarities and differences of the various international guidance documents and practices, both regulatory and non-regulatory will be described. 

Statistics will play a critical role in all stages of the Process Validation Lifecycle approach. Stage 3 provides the greatest and higher impact application of these tools to better control our processes and be more preventive in our efforts.

1:45 p.m. – 2:15 p.m.
Virus Filtration & Spike

Damon Asher, PhD, Senior Scientist Virology & Microbiological Sciences, EMD Millipore Corporation

1:45 p.m. – 2:15 p.m.
Visual Inspection of Injectable Products

John G. Shabushnig, PhD, Independent Consultant

1:45 p.m. – 2:15 p.m.
Process Validation: CMPC Guidance – Comparison to EMA Process Validation Guidance (Continued Process Verfication)

Scott Bozzone, PhD, Senior Manager, Validation, Quality Systems Technical Services (QSTS-V), Pfizer, Inc.

2:15 p.m. – 2:45 p.m.
Single Use

Robert Repetto, Senior Director, Pfizer, Inc.

2:15 p.m. – 2:45 p.m.
Steam In Place

Kevin Trupp, Principal Consultant, Sterilization Technology and Compliance

2:15 p.m. – 2:45 p.m.
TR Foundation: Statistics & Process Control

Greg Flexman, Process and Risk Analysis, Grifols, Inc.

2:45 p.m – 3:15 p.m.
Q&A

2:45 p.m – 3:15 p.m.
Q&A

IG8
Process Validation

Leader:
Scott Bozzone, PhD, Senior Manager, Validation, Quality Systems Technical Services (QSTS-V), Pfizer, Inc.

Hal Baseman, Chief Operating Officer, ValSource, LLC

Description:
There will be presentation and discussion on the latest hot topic in process validation at the time.  For example, we hope to have the FDA regulatory agency feedback to how the industry is reacting to the 2011 guidance on process validation.  The lifecycle approach, measuring the consumer and manufacturer risk levels in Stage 2 and 3 of the lifecycle could be other topics.  Also, we hope to have the EMA’s (European Medicine Agency) resolution to the comments due Oct 2012, on the Draft PV Guidance of March 2012.   This Guidance has several sterile products and aseptic processing statements.

Finally, there will be time allotted for open discussion.  We can share and benchmark with one another in the industry on these topics.

Speakers:

PPQ Lot Tool: Determining the Number of Lots in PPQ
Leslie Sidor, Director, Quality Engineering, Amgen, Inc.

IG9
Vaccines

Leader:
Frank S. Kohn, PhD, President, FSK Associates, Inc.

Description:
The Vaccines Interest Group (VIG) focuses on issues that affect the biological, biotechnology, and vaccine industry. The Interest Group has previously discussed regulatory issues, new technologies, and emerging industry trends. Recent issues include vaccine availability and supplies, homeland security, and inspection trends.

IG10
Pharmacoepial

Leader:
Karen Ginsbury, CEO, PCI Pharmaceutical Consulting Israel, Ltd.

Description:
This interest group is devoted to discussing issues and current concerns related to pharmacopeias.  The inaugural meeting of this group took place at the PDA/FDA Joint Regulatory Conference in 2012.

This second meeting will be a continuation of the initial discussion and will focus on some of the “hot topics” identified by the participants.

IG11
Visual Inspection of Parenterals

Leader:
John G. Shabushnig, PhD, Independant Consultant

Description:
We will review recent FDA 483 observations as well as recall activity related to visual inspection defects.  We will also review progress on development of USP General Chapter <790> Visible Particulates in Injections.  We will use this opportunity to discuss plans to update the PDA benchmarking survey of visual inspection practices.  We have conducted this study three times in the past at approximately 5-year intervals and we are due to revisit this topic. We will also use this opportunity to share discussions from the EU Visual Inspection IG meeting scheduled for late March 2013 with Annual Meeting attendees.  As in past meetings, we will use any remaining time for open discussion of inspection topics of interest to those in attendance.  Past topics have included inspector training and qualification, validation of automated inspection systems, the use of standards to assess inspection performance, new inspection technologies and the unique inspection challenges of biopharmaceuticals.

IG12
Packaging Science

Leader:
Roger Asselta, Vice President, Technical Affairs, Genesis Packaging Technologies

Description:
This session will provide an update of PQRI Parenteral & Ophthalmic Drug Products Extractables & Leachables Working Group, a review of USP Elemental Impurities Chapters – USP 232 and USP 232, as well as, an overview of the recent advances in the packaging of Cold Chain Products

Speakers:
A Review of the New USP Elemental Impurities Chapters – USP 232 and 233
Eugene T. Polini, Principal Technical Account Specialist, West Pharmaceutical Services

Status of the PDA Revised Technical Report 43 – Glass Packaging Nonconformities
Mark Fitzgerald, Technical Project Manager, NIPRO Glass Americas

Recent Advances in the Packaging and Distribution of Temperature-Sensitive Drug Products
Karl Kussow, Manager, Quality and Validation, FedEx Custom Critical

IG13
Lyophilization

Leader:
Edward H. Trappler, President, Lyophilization Technology, Inc.

Description:
As lyophilization is a constantly developing field there are always new perspectives in the science, technology and compliance realms.  This interest group provides an open forum for discussions on current topics.  Topics are identified at the onset of the meeting for open discussions among participants.  The informal forum provides a unique opportunity to learn from a variety of experiences and perspectives and provides an excellent benchmark for current industry practices.  Bring current topics of interest to you for discussion with your peers.

You can read highlights on past sessions in the July/August copy of the PDA letter.

IG14
Filtration

Leader:
Russell E. Madsen, President, The Williamsburg Group, LLC

Description:
The PDA Filtration Interest Group will meet in conjunction with the PDA 2013 Annual Meeting.  The Interest Group will meet on Tuesday, April 16 from 4:00 p.m. to 5:30 p.m.  Speakers representing Meissner, Millipore, Pall and Sartorius have been invited to speak on topics including retention of mycoplasma and small microorganisms and optimizing the total cost of ownership for membrane filtration.  There will be time for general discussion of topics of interest in addition to the formal presentations.

Speakers:
Optimizing Dead-End Filtration Processes and its Total Cost of Ownership
Mandar Dixit, Director, Marketing & Product Management – Filtration Technologies, Sartorius-Stedim Biotech

Retention of Mycoplasma and Small Microorganisms
Lia Jeffrey, Microbiological Scientist III, EMD Millipore Corporation, EMD Millipore Corporation

Safety Considerations for Gas Filtration in High Temperature & Oxygen Enrichment Applications
Monica Cardona, Marketing Manager, Global Air / Vent Product Manager, Pall Corporation

Mycoplasma Task Force Filtration Subgroup Update
Leesa McBurnie, Manager, Laboratory Services and Validation, Meissner Filtration Products, Inc.

Session Description:
Strategies and tips for advancing your career will be discussed by respected and highly experienced experts in biopharmaceutical recruiting and leadership development. The session will use a panel discussion format addressing audience questions. Don't miss this opportunity to understand todays demanding job market from some of the industry experts in career and leadership development.

Panel Participants:

• Jerry Cacia, Vice President, South San Francisco Production, Genentech, Inc.
• Mary Lavin, President, Sartorius Laboratories, Sartorius Stedim North America, Inc.
• Ira Mann, Director of Quality, Validation, and Regulatory Affairs Executive Search, FPC (Fortune Personnel Consultants) of Atlanta

Description:
The concept of Viral Safety is a moving target in the Biologics Industry.  As knowledge of viral contaminants grows, so does the need for ensuring the safety of commercial products derived from biological sources.  Therefore the assessment and mitigation techniques implemented today must ensure the safety of tomorrow's products, while acknowledging the need to prevent potential contamination by as yet unknown or unidentified viral risks. 

The potential for viral contamination has always been a risk to the commercial biological products industry.  Viral contamination may originate from source material or be introduced as incidental contamination during production processes.  Viral risk assessments and state of the art technologies, including nanofiltration, have emerged as rational, scientific and technological methods for mitigating this risk.    Viral risk assessments are critical to identifying potential virus safety risk events in the manufacture of biological products.  These risk assessments must take into consideration the challenges presented by the likelihood that viral contamination would occur and be detected.  Mitigation strategies are necessary to reduce and/or eliminate viral contamination in these products.  Evaluating and selecting an effective viral inactivation system can be a challenge since experience in this arena is constantly evolving.  Dr. Osherhoff and Dr. Ziegler will provide information on both of these innovative strategies during this session.

Description:
Single-use equipment and technology becomes increasingly employed. Single-use hold and mixing bags, filtration systems and connectors are widely used for many years. However, final technology hurdles in this area were filling and sensor technologies, both critical to the product quality at the end-point and as process monitoring tool. These “white fields” of single-use applicability are now getting covered by new technological advances and innovations. In this session, we will learn about medium to large scale precision filling using single-use systems, which avoid the need of cleaning and assembly. Sensor technology advances are critical to determine the process stability and support PAT. Again, these sensors are sort d for as single-use equipment. The described advances are platforms to build on further innovations.

Description:
Despite sound process design and planning, unwanted events may still occur. Properly investigating these events and process failures, identifying process failure causes, and determining corrective and preventive actions are therefore an essential element of an effective Quality System program. This session will present discussions on recent and important case studies, updates, and effective tools for conducting and closing investigations.

8:30 a.m. – 9:00 a.m.
Viral Risk Assessment & Screening

Wendy Osheroff, PhD, Section Head, Pathogen Safety Support and Compliance Grifols, Inc.

8:30 a.m. – 9:00 a.m.
Filling Systems for the Future

Lukas Munzinger, Sales Manager, Bosch Packaging Technology

8:30 a.m. – 9:00 a.m.
Low Endotoxin Recovery in Common Biologics Products

Anders Vinther, PhD, Vice President, Quality Biologics, Genentech, Inc.

9:00 a.m. – 9:30 a.m.
Techniques for Viral Risk Mitigation

Thierry Ziegler, PhD, Head of Bioprocesses, Sanofi-Aventis

9:00 a.m. – 9:30 a.m.
Advances in PAT Single-Use Sensors and Emerging Technologies

Govind Rao, PhD, Professor / Director, Center for Advanced Sensor Technology, University of Maryland Baltimore County

9:00 a.m. – 9:30 a.m.
Case Study: Finding the Root Cause in an Investigation

Johnnie Williams, Director, Quality Engineering/Quality Systems, DSM Pharmaceuticals, Inc.

9:30 a.m. – 10:00 a.m.
Q&A

9:30 a.m. – 10:00 a.m.
Q&A

10:30 a.m. – 12:15 p.m.
Closing Plenary Session: Focus on the Future

Moderator:  Ursula Busse, PhD, Head Project Office, Global Pharmaceutical Operations, Novartis Pharma AG,  Co-Chair, 2014 Program Planning Committee

10:30 a.m. – 11:00 a.m.
T-Cell Immunotherapy to Cure Cancer
Carl June, MD, Program Director, Translation Research, Professor, Department of Pathology & Laboratory Medicine, University of Pennsylvania Abramson Cancer Center

11:00 a.m. – 11:30 a.m.
The Future of Personalized Medicine
John Yu, MD,Vice Chair, Dept. of Neurosurgery, Cedars-Sinai Medical Center

11:30 a.m. – 12:15 p.m.
Q&A