pharmaceutical conference: microbiology east … · a: navigating the requirements of a modern qc...

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B: Contamination Control in Cleanrooms 13.30 - 17.30 Workshop Leader: Jim Polarine, Senior Technical Service Manager, STERIS Corporation PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS Wednesday 15th November 2017, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA www.microbiologyeastcoast.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 ACADEMIC & GROUP DISCOUNTS AVAILABLE @SMIPHARM #SMiMicroEast A: Navigating the requirements of a modern QC Microbiology Laboratory 08.30 - 12.30 Workshop Leaders: Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners, Inc. and Robert Ferer, Consulting Partner / Strategic Practice Lead, Quality Executive Partners, Inc. HIGHLIGHTS IN 2017: Learn more about Rapid Microbial Methods, Microbe Interaction and Stability Testing by implementing a Microbial Control Strategy to avoid failure Listen to in depth presentations about Environmental Monitoring, its challenges of avoiding risks and how to monitor and control microbial containment Expand your knowledge on Contamination Control and how to identify and improve this by learning from various case studies presenting different solutions Gather expert insight on different methods for Bacterial Endotoxin Testing, including a case study on Low Endotoxins Recovery strategies SMi present the 8th in its series... Pharmaceutical Microbiology East Co ast Discussing best practises for rapid microbial and sterility testing and tackling the challenges of contamination control CONFERENCE: 13TH - 14TH WORKSHOPS: 15TH NOV 2017 CHAIR FOR 2017: Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting KEY SPEAKERS INCLUDE: Joseph Chen, Executive Director, CMC Quality Control, Ultragenyx Pharmaceutical • Geeta Singh, Pilot Plant Technical Specialist III, Genentech • Somdutta Saha, Post-Doctoral Scientist, GlaxoSmithKline Tony van Hoose, Director, Sterile Technologies Expertise, Sanofi • Frederic Ayers, Consultant Scientist, Sterility Assurance, Eli Lilly David Huang, Chief Medical Officer, Motif Bio Andrew Bartko, Research Leader, Battelle Memorial Institute Sponsored by Renaissance Woodbridge Hotel, Iselin, New Jersey, USA BOOK BY 30TH JUNE 2017 AND SAVE $300 BOOK BY 29TH SEPTEMBER 2017 AND SAVE $100

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B: Contamination Control in Cleanrooms

13.30 - 17.30

Workshop Leader: Jim Polarine, Senior Technical Service Manager,

STERIS Corporation

PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 15th November 2017, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

www.microbiologyeastcoast.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

ACADEMIC & GROUP DISCOUNTS AVAILABLE@SMIPHARM

#SMiMicroEast

A: Navigating the requirements of a modern QC Microbiology Laboratory

08.30 - 12.30

Workshop Leaders: Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners, Inc. and Robert Ferer, Consulting Partner / Strategic

Practice Lead, Quality Executive Partners, Inc.

HIGHLIGHTS IN 2017: • Learn more about Rapid Microbial Methods, Microbe

Interaction and Stability Testing by implementing a Microbial Control Strategy to avoid failure

• Listen to in depth presentations about Environmental Monitoring, its challenges of avoiding risks and how to monitor and control microbial containment

• Expand your knowledge on Contamination Control and how to identify and improve this by learning from various case studies presenting different solutions

• Gather expert insight on different methods for Bacterial Endotoxin Testing, including a case study on Low Endotoxins Recovery strategies

SMi present the 8th in its series...

Pharmaceutical Microbiology East Coast Discussing best practises for rapid microbial and sterility testing and tackling the challenges of contamination control

CONFERENCE: 13TH - 14TH

WORKSHOPS: 15TH

NOV 2017

CHAIR FOR 2017: • Jeanne Moldenhauer, Vice President,

Excellent Pharma Consulting

KEY SPEAKERS INCLUDE:• Joseph Chen, Executive Director, CMC Quality Control,

Ultragenyx Pharmaceutical• Geeta Singh, Pilot Plant Technical Specialist III, Genentech • Somdutta Saha, Post-Doctoral Scientist, GlaxoSmithKline• Tony van Hoose, Director, Sterile Technologies Expertise, Sanofi • Frederic Ayers, Consultant Scientist, Sterility Assurance, Eli Lilly• David Huang, Chief Medical Offi cer, Motif Bio• Andrew Bartko, Research Leader, Battelle Memorial Institute

Sponsored by

Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

BOOK BY 30TH JUNE 2017 AND SAVE $300BOOK BY 29TH SEPTEMBER 2017 AND SAVE $100

Register online at www.microbiologyeastcoast.com

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking

opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: [email protected]

For over 30 years, Charles River has helped customers bring products to market safely and efficiently with

revolutionary technologies and exceptional services that have changed the way we conduct microbial

quality control. Continuing with a passion to innovate and respond to customers’ needs, our Microbial Solutions

group has purposefully expanded its global portfolio to include the leading rapid microbial detection systems

of Celsis®. Joining the trusted brands of Endosafe® endotoxin testing and Accugenix® microbial identification,

Celsis® creates a powerful trio of micro QC solutions, the most comprehensive offering available from any

single provider. www.criver.com/microbialsolutions

Sponsored by

08.30 Registration & Coffee

09.00 Chair’s Opening Remarks Jeanne Moldenhauer, Vice President,

Excellent Pharma Consulting

MICROBIAL CONTROL STRATEGIES AND QUALITY METHODS

OPENING KEYNOTE ADDRESS: 09.10 The Role of Microbiology in Pharmaceutical Stability Programs • Stability Study Requirements: R&D versus Marketed Products • What Microbial Tests are Stability Test Parameters • Stability Testing Appropriate for Different Dosage Forms • Managing the Stability Commitments in your Regulatory Filings • Investigating Stability Test Failures Tony Cundell, Principal Consultant,

Microbiological Consulting, LLC

09.50 How does a Non-GMP Biopharmaceutical Pilot Facility deliver high run rate with high success?

• CHO and E. coli process development overview • Provide an overview of the premier Pilot Plant facility in Biotech

USA that executes more than 1500 CHO and E. coli experiments per year to support Genentech’s pipeline

• Discuss microbial contamination case studies and the lessons learned

• Discuss how critical it is to maintain good health of the non-GMP facility to achieve high success rate

Geeta Singh, Pilot Plant Technical Specialist III, Genentech

10.30 Morning Coffee & Networking Break

11.00 Amplified ATP Bioluminescence Rapid Sterility Test Validation Utilizing a Defined Method for Stressing Microorganisms

• Provides an efficient, and reproducible method for generating log reductions in microbial cultures

• Comparative data / illustrations shall be presented to demonstrate stressing procedural efficacy

• The impact of stressed organisms on Time to Detect, and Limit of detection shall be demonstrated

Shawn Sweeney, Senior Process Development Manager, Charles River

11.40 Deciphering the Host-Microbe Interaction • The microbiome is implicated in several chronic disorders • The metabolites produced by the microbes are chemical

messengers interacting with host receptors • Studying this interaction will have important knowledge building

around disease pathologies Somdutta Saha, Post-Doctoral Scientist, GlaxoSmithKline

12.20 Networking Lunch

ENVIRONMENTAL MONITORING TO AVOID POTENTIAL RISKS

13.30 Benefits of Real-time Monitoring of Airborne Viable Microorganisms

• Bio-fluorescent active air particle counting of airborne viable microorganisms

• Continuous real-time Environmental Monitoring of Classified Environments

• Risk mitigation James Hauschild, Principal Scientist, Johnson & Johnson

14.10 Current Expectations for a Complete Environmental Monitoring Program

• Increasing expectations for non-sterile manufacturers • Types of functions that should be included in the program -

besides monitoring • What is required in these functions • How to put the system together Jeanne Moldenhauer, Vice President,

Excellent Pharma Consulting

14.50 Microbial Environmental Control Assessment using Microbial Recovery Trends

• Microbial Recovery rate trend analysis is stated by USP <1116> to evaluate microbial control levels in aseptic process areas

• Microbial Recovery rates trend analysis has demonstrated being an excellent toll to determine the efficiency of microbial control corrective actions

• The purpose of this presentation is to review the results of our assessment in classified areas

Angel Salaman, Principal Process Scientist, Janssen Biotech

15.30 Afternoon Tea & Networking Break

BACTERIAL ENDOTOXIN TESTING AND LER STRATEGIES

16.00 Quality Control Strategy on Low Endotoxins Recovery (LER) • Discuss common formulation ingredients in biologics cause LER • Risk assessment approach in mitigating LER impact on product

quality • Case study on analytical solution to LER and alternatives Joseph Chen, Executive Director, CMC Quality Control,

Ultragenyx Pharmaceutical

16.40 Method Development • How to determine the Maximum Valid Dilution (MVD) • Endotoxin inhibition / enhancement • How to determine endotoxin limits on raw materials and

excipients Josephine Chan, Microbiology Supervisor, Teligent Pharma Inc.

17.20 Chair’s Closing Remarks and Close of Day One

Pharmaceutical Microbiology East Coast Day One | Monday 13th November 2017 www.microbiologyeastcoast.com

Register online at www.microbiologyeastcoast.com Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

MARKETING OPPORTUNITIESWant to know how you can get involved? Interested in promoting your services to this market?

Contact Kyra Williams, SMi Marketing on +44 (0) 207 827 6012 or email: [email protected]

08.30 Registration & Coffee

09.00 Chair’s Opening Remarks Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting

CONTAMINATION CONTROL AND STERILITY ASSURANCE

OPENING ADDRESS: 09.10 Implementation of a Risk Based Model for Cleaning and

Disinfection • Development of a risk based model for cleaning and

disinfection • Using a risk model for room recovery following an adverse event • Implementation strategy for introducing a risk based cleaning

and disinfection regimen Steve Walton, Technical Manager, Sanofi Pasteur

09.50 Contamination Challenges • Combatting Mold: Introducing a simple method to eliminate

and prevent mold anywhere • Discussing fast and simple methods to eliminate and prevent

biofi lm • Easy ways to eliminate spores quickly and safely for your

equipment/surfaces Brian Hubka, CEO, BGH International

10.30 Morning Coffee & Networking Break

11.00 Training of Media Fill Inspection Operators • Training Program Overview • Creation of Positive Containers • Test/Inspection Conditions • Certifi cation of Operators • Recertifi cation/Retraining – Frequency and Basis Tony van Hoose, Director, Sterile Technologies Expertise, Sanofi

KEYNOTE ADDRESS11.40 Implementation of a Global Electronic Intervention Logging System Sterility is one of the most critical quality attributes that all

parenteral products must possess; yet, it is one of the most diffi cult to consistently and convincingly demonstrate. This presentation discusses an integrated, cross-functional strategy implemented within Eli Lilly and Company’s parenteral manufacturing network. This strategy identifi es, assesses, documents, and evaluates the single largest source of microbial hazard within aseptic fi lling areas – aseptic personnel.

• This presentation will describe an Aseptic Manipulation and Intervention Program, which establishes the requirements for how aseptic interventions and manipulations are identifi ed, assessed, and executed

• This presentation will describe the Intervention Logging System which allows for real-time electronic documentation and approval of non-coded interventions performed on aseptic fi lling lines

• This presentation will describe the use of RFID for documentation of Electronic Signature for activities within the aseptic areas

Collectively, these provide quantifi able information that helps mitigate the risk of personnel-induced microbial hazard of products fi lled in aseptic environments.

The attendees will understand the importance of developing a robust intervention strategy with appropriate defi nitions of activities. Additionally, identifying, assessing and mitigating all aseptic interventions and manipulations allow for consistent evaluation of fi ller performance across a platform.

Frederic Ayers, Consultant Scientist, Sterility Assurance, Eli Lilly

12.20 Networking Lunch

RAPID MICROBIAL DETECTION AND DESIGNED THERAPIES

13.30 Rapid microbial-detection methods • The benefi ts, applications, pitfalls and challenges involved • Time to result benefi ts to manufacturing economics • Enhanced quality control impact on manufacturing risk • Overcoming the hurdles of new technology validation Andrew Bartko, Research Leader, Battelle Memorial Institute

14.10 Designed microbiome therapies targeting the microbes and beyond • The gut microbiome plays an essential role in disease regulation

and effi cacy of therapies. Altered microbial communities, also termed dysbiosis, has been observed in many intestinal and extra-intestinal infl ammatory disorders

• There is not yet a clear understanding whether dysbiosis is a cause or a consequence of the diseases. Microbial therapies which only target the dysbiosis have shown limited success

• A healthy gut microbiota exists in an equilibrium with the gut barrier and the immune system

• The importance of multiple-target drug cocktails comprising commensal bacteria will be discussed. The bacterial library, screening technologies and design of potential and affordable drugs will be presented with particular focus on successful products that treat Irritable Bowel Syndrome (IBS) and Clostridium Diffi cile Infection

Shahram Lavasani, Founder & CEO, ImmuneBiotech AB

14.50 Afternoon Tea & Networking Break

15.20 Iclaprim, a novel diaminopyrimidine, for the treatment of serious Gram-positive infections

• Iclaprim addresses an unmet medical need in hospitalized patients with serious and life threatening infections including MRSA

• Iclaprim possesses a differentiated product profi le in target patient populations

• Iclaprim provides a near-term product opportunity David Huang, Chief Medical Offi cer, Motif BioSciences

16.00 Biological Treatment of Emerging Contaminants Prevalent in Pharmaceutical Effl uents

• Pharmaceutical wastewater commonly consists of contaminants of emerging concerns, such as antibiotics, estrogens, and 1,4-dioxane

• Bacteria that can degrade or biotransform these xenobiotic compounds are more widespread than previously recognized

• Modern culture-independent biotechnologies facilitate the identifi cation of microorganisms with unique biotransformation capabilities

• Biologically active fi ltration system is one of top effective and economical techniques for removal of commingled emerging contaminants in pharmaceutical waste streams

Mengyan Li, Assistant Professor, New Jersey Institute of Technology

16.40 Chair’s Closing Remarks and Close of Day Two

Pharmaceutical Microbiology East Coastwww.microbiologyeastcoast.com Day Two | Tuesday 14th November 2017

Supported byOffi cial Media Partners:

A: Navigating the requirements of a modern QC Microbiology Laboratory

Overview of the workshop:This workshop will introduce ideas for blending traditional microbiology with the cutting edge methodologies that are available to the industry, both inside the laboratory and on the manufacturing fl oor for routine monitoring programs. It will also provide practical approaches for common laboratory issues surrounding implementation of alternative technologies, data integrity and analyst training.

Why you should attend:This workshop is designed to inspire and motivate the attendee for understanding the evolution of microbiological methods in pharmaceutical manufacturing, and basic expectations for building quality into the product.

Programme08.30 Registration & Coffee09.00 Opening Remarks09.10 Session 1 - The Modern Microbiology Lab • Learn about current trends in QC Microbiology • Solutions for when to upgrade technology in your lab09.50 Session 2 - Real Time Release Testing • Learn about options available for monitoring water

& products in real time • Discuss the creation and application of new

excursion criteria10.30 Morning Coffee11.00 Session 3 - Data Integrity in a Digital Lab • Application of data integrity for conventional &

alternative lab methods • Practical approaches & safeguards against

common mistakes11.40 Session 4 - The iMicrobiologist • Blending old & new technologies in the QC

Microbiology lab • Understanding, hiring & training the new

generation of talent12.20 Closing Remarks12.30 Close of Workshop

About the workshop leaders:Vanessa Vasadi-Figueroa, Pharmaceutical Microbiologist and Consulting Partner, has more than 12 years combined experience in Pharmaceutical, Biotechnology and Medical Device industries. Mrs. Figueroa has expertise in sterility assurance, environmental and utilities monitoring programs and quality control laboratory management. Her consulting experiences have spanned both domestic and international large pharmaceutical companies, applying both US and global regulatory standards of quality. Mrs. Figueroa has a Bachelor’s degree in Molecular Biology from State University of New York at New Paltz, and a Master’s degree in Molecular Biology and Microbiology from San Jose State University. She is an active and contributing member of several professional organizations, such as the Parenteral Drug Association, American Society of Microbiology and Association for Women in Science.

Robert Ferer, Engineering Chemist and Consulting Partner with more than 28 year’s direct industry experience including the design, build, start-up, and management of facilities, specializing in aseptic manufacturing. Mr. Ferer’s experience covers all aspects of pharmaceutical operations from receipt of raw materials through inspection, fi nal packaging, and shipping of fi nished products. As a consultant, he is frequently contracted to manage large-scale projects and provide high-level strategy and goal defi nition to clients. This includes due diligence, facility audits, compliance, and regulatory guidance for North America as well as EU markets. Mr. Ferer has a Bachelors degree in Engineering Chemistry from the State University of New York at Stony Brook and is a contributing member of both the International Society of Pharmaceutical Engineers and the Parenteral Drug Association.

About the company:At Quality Executive Partners (QxP), our mission is to bring bold revolution to quality consulting. We are fueled by the passion for doing what is right and being the much needed disruptive innovation! The QxP team is comprised of executives with extensive track records delivering successful outcomes in situations of intense regulatory scrutiny. Our executives have substantial experience interacting and negotiating with FDA and other global regulatory agencies. We take a pragmatic, strategic view of internal processes, quality system development, and implementation of key matters.

Workshop Leaders: Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical

Microbiologist, Quality Executive Partners, Inc.Robert Ferer, Consulting Partner / Strategic Practice Lead,

Quality Executive Partners, Inc.

HALF-DAY POST-CONFERENCE WORKSHOPWednesday 15th November 2017

08.30 – 12.30Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

B: Contamination Control in Cleanrooms

Overview of the workshop:Staying ahead of the curve with Contamination Control requires an understanding and an anticipation of the constantly changing microbial climate of the pharmaceutical manufacturing process. Knowing the characteristics of the environments in that process provides the benefi t of allowing us to predict and solve potential future microbial control issues. This session will discuss pathways to use the data obtained from environmental monitoring to provide proactive and practical solutions for comprehending and managing everyday pharmaceutical microbiology challenges. This workshop will cover case studies on human fl ora and spore contamination in cleanroom operations. Solutions will be discussed to proactively present future contamination issues.

The workshop will cover the most common causes of contamination: operators, items brought into the cleanroom, and degradation of the cleanroom over time. Case studies in operator borne contamination will be discussed as well as preventative long term solutions. Specifi c examples of aerobic and anaerobic vegetative bacteria will be highlighted and analyzed. Items brought into cleanrooms that can harbor fungal and bacterial spores will be discussed as well as specifi c case studies highlighting examples where sources were items brought into the cleanroom or in some cases other common causes. Fungal and bacterial spore structures as well as effi cacy testing and specifi c test conditions will be covered. Solutions will be presented to prevent effi cacy testing failures due to test method, recovery, and coupon porosity issues. Targeted long term solutions will be discussed regarding the spore case studies in a concerted effort to limit reoccurrences.

The overall objective and scope of this workshop will be to discuss specifi c cases studies that have occurred in my years of experience in the industry. Specifi c long term solutions will be conveyed to prevent reoccurrences and yield higher levels of control in the cleanroom operations. The concepts of cleaning and disinfection, application frequency, disinfectant rotation, and rinsing and residue removal strategies will be covered in complete detail as well.

Why should you attend this workshop:This industry workshop will give attendees valuable insight into the world of contamination control and troubleshooting fungal and bacterial spore excursions in cleanrooms. Attendees will gain new insight into common causes of CAPA investigations which will cut down on time that is invested fi nding potential causes for contamination which can cost an organization 50K per investigation.

Programme13.30 Registration & Coffee14.00 Opening Remarks and Introductions

14.10 Session 1 - Common Sources of Contamination: Case Studies

14.50 Session 2 - A Risk Based Cleaning and Disinfection Program

15.30 Afternoon Tea

16.00 Session 3 - Key Elements of a Successful Disinfectant Validation Program

16.40 Session 4 - Bringing the Cleanroom Online After a Worst-Case Event

17.20 Closing Remarks17.30 Close of Workshop

About the workshop leader:Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for seventeen years. His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

About the organisation:STERIS is a global leader in infection prevention, contamination control, surgical and critical care technologies, and more. STERIS is the world’s pre-eminent infection prevention, decontamination, and surgical and critical care company.

Workshop Leader: Jim Polarine, Senior Technical Service Manager,

STERIS Corporation

HALF-DAY POST-CONFERENCE WORKSHOPWednesday 15th November 2017

13.30 – 17.30Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

PHARMACEUTICAL MICROBIOLOGY EAST COAST Conference: Monday 13th & Tuesday 14th November 2017, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Workshops: Wednesday 15th November 2017, New Jersey, USA

4 WAYS TO REGISTERwww.microbiologyeastcoast.com

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