Events Overview

2017 Special Events

NOW more than EVER….INTERPHEX is the Place to Find the Solutions you Need to Help Lower the Cost of Development and Manufacturing

INTERPHEX Grand Opening Ceremony

Grand Opening Sponsor:
Grand Opening Sponsor Alcami Corporation
Booth: 1405

Learn It, Experience the latest in Technology with our No Cost INTERPHEX Technical Conference:

"Moving the Industry Forward and Beyond: Leveraging Efficiency, Quality and Cost Effectiveness"

Session Tracks

  • Continuous Manufacturing Opportunities Keep Expanding
  • Leveraging Quality Systems & Strategies in a Heavily Regulated Environment
  • Implementing Modularity and Speed in Facilities/Facilities Management
  • Enhancing Processing & Production Utilizing Innovation
  • Enabling Technologies to Streamline Operations
  • Bringing your Vision to your Reality via the Contract Services Solutions
View 2017 Technical Education Program

INTERPHEX Live: Valuable Insight from Industry Experts.

Tuesday/Wednesday: March 21-22, 10:15am – 4:45pm
Thursday: March 23, 10:15am – 12:15pm
Crystal Palace, Booth 2

A technology-focused three-day live event, focused on Lowering the Cost of Developing and Manufacturing Product, presented right on the show floor enables industry professionals to gain valuable insights in a live, talk-show format. Both attendees and exhibitors will have the opportunity to view the presentations and panels live via our show floor studio, broadcast throughout the show floor and “on-demand” viewing post- show.

This year’s program continues to deliver the cutting-edge topics and technical insight to address industry challenges that you expect INTERPHEX to deliver

  • Brexit: Impact on Global Submissions
  • Enabling Technologies to Streamline Operations
  • Internet of Things: Technology Connectivity and the Transformation of Manufacturing
  • Streamlining Operations Using AR/VR
  • Fortem: Challenges and opportunities in developing a new plastic film for bioprocess activities
  • DSCSA: New Regulations Require Action
  • Biosimilars 3.0
  • Quality Metrics/Quality Agreements
  • The Changing Regulatory Landscape: Looking from the Outside In
  • Capsules: The Go-To Dosage Form
  • Continuous Manufacturing Opportunities Keep Expanding in Pharma
  • The Future of Flexible Manufacturing
  • Realizing Benefits and Efficiencies from Quality Systems
  • cGMP Clean Space: Innovative Solutions for Compliant and Cost-Effective Facilities
  • Serialization
  • Evolution of Pre-filled Syringes
  • Regulatory Aspects of Continuous BioProcessing
  • Trends in Medical Devices

INTERPHEX Exhibitor Awards

Tuesday, March 21, 9:45am – 10:00am
Exhibit Hall Entrance

The 3rd Annual Exhibitor Awards! Winners are recognized and awarded for showcasing innovative technologies and/or new strategies and services that have significantly contributed to the industry. A highly esteemed group of industry experts select the winners:

  • Best In Show
  • Best New Product/Service, Editor’s Choice
  • Editor’s Choice
  • Best Technology Innovation
  • Efficiency Champion
  • Biotech Innovation

Learn more about the 2017 INTERPHEX Exhibitor Awards

CRB Tech Tank

Tuesday, March 21, 1:30pm-4:15pm
INTERPHEX Technical Conference Stage 2, Booth 1177, Exhibit Hall

At the CRB Tech Tank, CRB subject matter experts offer new technical content.

Sporeformers & Biocontainment: Designing to Mitigate Risk and Avoid “Threat Level Midnight”

  • Allan Bream, Associate, Lead Biopharmaceutical Specialist, Sheela Prabhu, AIA, LEED AP, Project Architect

Stress Testing, Mitigating Risks and Remediation: How to Maintain a Fit Facility

  • Andrew Harris, Associate, Lead Process Engineer Joe Povenski, Process Specialist

The Future of Oligonucleotides

  • Bill Jarvis, Senior Associate, Senior Process Specialist, Christa Myers, Associate, Senior Pharmaceutical Engineering Specialist, Lindsay Kenney, Business Unit Leader, Andrew Burley, PE, Lead Process Engineer, Brendan Nichols, Process Engineer

NEW for 2017: SKAN Exclusive: In-Booth Learning and Launch Event

Tuesday, March 21, 5:00pm – 6:00pm
SKAN US Booth 3140, Exhibit Hall

SKAN presents a unique opportunity to gain knowledge and updates from SKAN’s Sterility Testing Conference and Aseptic Barrier Technical Summit held in October 2016. Techniques and lessons learned from manufacturing companies will be shared along with a demonstration video of the exciting new SKAN NANOX Catalyst Technology.

Tuesday/Wednesday, March 21-22: 5:00pm – 6:00pm
Thursday, March 23, 10:00am - 3:00pm
SKAN US Booth 3140, Exhibit Hall

NEW: In-booth Demo and Interaction with Isolation Systems

SKAN is also highlighting its award winning modular small-scale aseptic processing isolator, Pharmaceutical Safety Isolator, (PSI-L) with SARA® Material Airlocks for conventional aseptic applications.

NEW: Exclusive Learning and Launch Event
Beginning at 5:00pm on Tuesday, SKAN will present at our booth a unique opportunity to gain knowledge and updates from SKAN’s Sterility Testing Conference and Aseptic Barrier Technical Summit held in October 2016. Techniques and lessons learned from manufacturing companies will be shared along with a demonstration video of the exciting new SKAN NANOX® Catalyst Technology.”
Tuesday, March 21: 5:00pm – 6:00pm

DME Facility Focus

Tuesday, March 21, 10:30am-11:30am; 1:00pm-2:00pm
INTERPHEX Technical Conference Stage 2, Booth 1177, Exhibit Hall

Encompasses feedback and analysis regarding the future of cGMP facilities, as well as guidance on how new technologies can transform current manufacturing operations. Based on survey data derived from polling a range of professionals.

Session #1: cGMP Facility Modernization: New Solutions for Aging Facilities

Led by David M. Marks, PE, President, DME

Leveraging this year’s DME Facility Focus survey on Biopharmaceutical Facility Modernization, this presentation and industry panel discussion will focus on the opportunities and risks associated with renovations of GMP facilities. Our panel of experts will be discussing current trends and technologies available to transform legacy facilities—in order to enhance bio-manufacturing flexibility and ensure the reliability of drug substance supply train.


Session #2: Next Generation Aseptic Manufacturing: An Eye-Opening Peek into The Future

Led by Hite Baker, Principal Process Engineer, DME

Join us for an eye-opening peek at the future of sterile manufacturing. Our panel of experts will focus on sterile manufacturing technology trends that manage risk and enhance product quality in parenteral fill/finish facilities. Inspired by analysis of results from the most recent DME Facility Focus survey on Aseptic Manufacturing Technology Trends, this dialog will examine the key issues of our day and how they impact our industry. Topics include manufacturing modernization, isolators & RABs, equipment decontamination, robotics, single-use technology, process flexibility, and evolving regulatory expectations for these facilities.

Pharmaceutical Technology’s Keynote Series at INTERPHEX

Tuesday, March 21/Wednesday, March 22
INTERPHEX Innovation Stage, Booth 1170, Exhibit Hall

Presented by INTERPHEX and Pharmaceutical Technology, the Keynote Series offers highly regarded industry experts offering their perspective on the industry’s hottest topics.

Tuesday, March 21, 10:30am – 12:30pm

Serialization and Traceability: The Final Countdown
As the November, 2017 deadline for serialization implementation in the US approaches, most, but not all, bio/pharma companies and contract pharmaceutical manufacturers have developed strategies for compliance. In this keynote session, speakers will look at the state of implementation, as well as best practices, results of pilot tests and research, and discuss a new program designed to help accelerate progress for companies that have not yet addressed requirements.

Session
Moving from Compliance to Value: A State of the Industry Report
What progress have pharmaceutical manufacturers and their supply chain partners made in implementing traceability initiatives? In these final months before the Drug Supply Chain Security Act implementation deadline, what technical and cultural issues remain? This session will examine results of an extensive industry survey and focus on areas where serialization and traceability projects can bring significant business value.

Speaker from TraceLink

Session
Accelerating Compliance in the Final Stretch
Even though the deadline for serialization compliance is months away, a few companies not have developed serialization strategies and finalized technical initiatives. Speakers discuss a new program, based on open standards and basic data communication templates, that aims to get companies up and running in time to meet the deadline.
Speakers from TraceLink and Ropack Pharma Solutions

Speakers from TraceLink and Ropack Pharma Solutions

Session
BlockChain as a Supply Chain Tool

What is blockchain and how could it help boost supply chain security? Speakers will provide an overview of the technology, and discuss results of research into the use of blockchain within the pharma industry.
Speakers: Robert Celeste, Founder, Center for Supply Chain Studies, and Darryl Glover, chief clinical officer, i-Solve.
Robert Celeste established the Center for Supply Chain Studies in Chicago. He was formerly senior director at GS1 US.
Darry Glover is chief clinical officer at i-Solve. He has previously worked as an independent consultant, and as CEO of The Lumine Group.

Tuesday, March 21, 1:30pm – 3:00pm

Implementing Continuous Manufacturing for Solid-Dosage Drugs
Continuous manufacturing for solid-dosage drugs offers the potential for greater flexibility, efficiency, and quality. Early adopters now have FDA approval for drugs made with continuous processes. Equipment and process analytical technology for continuous tablet production is available. This session will look at some of the available technologies and at the challenges that remain.

Session
Different Approaches to Continuous Manufacturing within the Pharmaceutical Industry
The pharmaceutical industry is in the process of modernizing its manufacturing practices. Companies are replacing outdated batch unit operations with more innovative, efficient, and automated continuous processes. Different approaches are being utilized, from targeted solutions to integrated end-to-end strategies, each with its own risks and benefits. There are many drivers for this transformation, including pressure to reduce drug costs and more stringent quality requirements imposed by regulators. This presentation will examine the different tactics companies are employing and their respective advantages, with a focus on small-molecule drugs.

Speaker: Bayan Takizawa, MD, MBA, Co-Founder & Chief Business Officer, CONTINUUS Pharmaceuticals, Inc.

Session
Automating Continuous Manufacturing
More companies are making the move towards continuous manufacturing. Smart data solutions must be provided to streamline the dataflow and get the essential information out of the big data stream. This presentation will dive into the mechanism of continuous manufacturing, leaving the isolated ‘islands of automation’ and working towards a fully integrated approach. Real, established use cases will demonstrate how a process analytical technology (PAT) approach can be established in a continuous manufacturing area.

Speaker: Pamela (Bruen) Docherty, Life Sciences Industry Manager – USA, Siemens

Advancing Continuous Solid-Dosage Manufacturing
Over the course of the past decade the foundations for today's continuous pharmaceutical manufacturing have been developed through public private partnerships like C-SOPS. This is particularly true in the case of solid dose. Today, as the interest in transitioning to this new means of manufacturing continues to grow we continue to develop new ways to better enable technological adoption. Here we will present some of the newest innovations for faster development of products using less material along with programmatic activities aimed at easing the regulatory pathway.

Speaker: Doug Hausner is Associate Director for Industrial Relations and Business Development at the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) at Rutgers University, department of Chemical and Biochemical Engineering.

Wednesday, March 22, 10:30am – 12:30pm

Best Practices in Equipment Cleaning and Cleaning Validation
Efforts are underway to bring more scientifically-based standards to cleaning validation. Speakers will discuss new developments, and various areas of focus in a dynamic subject.

Session
A New ASTM Standard for Cleaning Validation
Guidelines previously published by ISPE and under development for the past five years are now being combined in a “Standard Guide for Science and Risk-based Cleaning Process Development and Validation,” a standard now under development by the American Society for Testing and Materials (ASTM).

Speakers: Andrew Walsh, President of the Center for Pharmaceutical Cleaning Innovation, and others TBA

Session
Training for Qualification
Successful cleaning validation is critical to patient safety. This presentation will examine PDE and ADE cleaning limits, and what is needed for qualification for visual inspection.

Speaker: Rich Forsythe, Principal Consultant, Forsyth Pharma Consulting

Wednesday, March 22, 1:30pm – 3:00pm

Post-Approval Changes: Addressing Regulatory Roadblocks
Changes to a manufacturing process during the lifecycle of a drug product are inevitable. New regulations, materials suppliers, and facility and equipment updates can contribute to improved processes. The complications and costs of implementing these changes, particularly in a global environment, may discourage companies from updating facilities and systems, contributing to a downward quality spiral. This session will examine ongoing challenges with implementing post-approval changes, efforts to educate and harmonize national and regional regulations, and will feature an approach to address post-approval changes during the initial application process.

Session
Industry Perspective and Issues on Post-Approval Changes

Speaker: Maik Jornitz, G-Con LLC, Member, PDA Innovation for Availability of Medicines (PAC iAM) Task Force

Session
Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process

Pharmaceutical companies filing drug applications for the Japanese market must submit bracketing strategies for aspects of the manufacturing process including process parameters, quality attributes, operating and storage conditions, type and concentration of materials used, and proposals for handling post-approval changes. This is typically done by enclosing critical and non-critical aspects of the manufacturing process in major and minor brackets, respectively. Any post-approval changes in these strategies require appropriate regulatory action. Each bracketing strategy offers advantages and limitations, and determines whether a manufacturing deviation is allowed or not and whether a pre-approval for implementation of a post-approval change is required or not. Important aspects related to bracketing strategies will be discussed.

Speaker: Kashappa Goud Desai, PhD, Biopharmaceutical Product Sciences, GlaxoSmithKline

IPS Technologies Tours

Glass Room, Lobby Mezzanine

Wednesday, March 22; 10:00am and repeated at 1:00pm
3:00pm-5:00pm – IPS Technologies Tour Reception; By Invitation Only

Walking show floor tours offering insight into the latest equipment, innovation and manufacturing technologies offered by leading vendors and internationally recognized experts.

Tours include: Aseptic Small-Scale/Modular Technologies, Aseptic Full-Scale & Flexible Technologies, Biomanufacturing Technologies, Modular Construction Technologies, OSD Continuous Manufacturing Technologies, Packaging & Inspection. Reservations required.

Register For IPS Technologies Tours Here

IPS Aseptic Small-Scale/Modular Technologies Tour

Tour Leaders: Paul Valerio, Jason S. Collins, RA, NCARB, Jerrod Shook, and Rob Roy, P.E.
Exhibitors include: Bausch + Stroebel Machine Company, Inc., Franz Ziel USA Inc.,
groninger USA L.L.C., Stevanato Group, SKAN US, Inc., and Vanrx Pharmasystems Inc.

Aseptic Small-Scale/Modular Description: The Aseptic Small-Scale/Modular Tour at INTERPHEX will focus on modular solutions for clinical and small-scale commercial filling. A number of vendors have developed targeted solutions to meet these unique requirements over the past several years. Current technologies allow users to maximize yield of high value or limited supply (e.g. early stage) products and to fill products in multiple formats using a single modular isolator system. This provides a cost effective solution to clinical manufacturing operations that is fully compliant with current and anticipated regulatory requirements for aseptic filling.

IPS Aseptic Full-Scale & Flexible Technologies Tour

Tour Leaders: Paul Valerio, Jason S. Collins, RA, NCARB, Jerrod Shook, and Rob Roy, P.E.
Exhibitors include: Bosch Packaging Technology, GEA North America, IMA Life North America, Inc., OPTIMA Machinery Corporation, and Rommelag USA, Inc.

Aseptic Full-Scale & Flexible Description: The Aseptic Full-Scale & Flexible Tour at INTERPHEX will focus on new and convergent technologies for large scale commercial & flexible commercial manufacturing. Larger scale flexible equipment for filling multiple product formats on a single line is now available. Furthermore, recent improvements in key interrelated technologies also allow for faster change-over times, reduced decontamination times, and increased use of single use fluid path components to improve operating efficiencies and reduce manufacturing costs for commercial scale products.

IPS Biomanufacturing Technologies Tours

Tour Leaders: Tom Piombino, P.E., Sue Behrens Ph.D., Theodore Cohen, MEM, and
Erich Bozenhardt, P.E.
Exhibitors include: AdvantaPure®/NewAge Industries, Inc., Asahi Kasei Bioprocess America, Inc., Germfree Laboratories, Inc., MilliporeSigma, and Thermo Fisher Scientific

Biomanufacturing Description: The Biomanufacturing Tour at INTERPHEX will provide end-user company attendees with the opportunity to learn about new and evolving batch and perfusion biomanufacturing technologies as well as network with the key equipment manufacturers bringing these products to market. Single-use systems and the supply chain supporting them will be heavily reviewed and discussed as each manufacturer differentiates themselves through a host of different methodologies. Additionally, the trends in follow on vendor support services like CQV, URS development and full process train integration will be a significant emphasis.

IPS Modular Construction Technologies Tours

Tour Leaders: Dan Leorda, P.E., Donald Hamme, William O’Brien and Kevin Batche
Exhibitors include: A&B Process Systems, AES Clean Technology, Inc., G-CON Manufacturing, Inc., M. Davis & Sons, Inc., and Pharmadule Morimatsu AB

Modular Construction Description: The Modular Tour at INTERPHEX will provide exposure to a variety of critical unit operations in modular design and construction. Tour attendees will be previewed to the benefits of Modularization and observe state-of-the-art modular components on display and in demonstration, as well as receive dedicated presentations and insight into the latest advances in Construction Management including Cost Benchmarking from industry’s leading experts..

IPS Oral Solid Dosage Continuous Manufacturing Technologies Tours

Tour Leaders: Mike Vileikis, Sam Halaby, Lonna Gordon, and Brian Egan, R.A., LEED AP, NCARB
Exhibitors include: Driam USA, Inc., GEA North America, Gebrüder Lödige Maschinenbau, GmbH, Glatt Air Techniques, Inc., and LB Bohle LLC

OSD Continuous Manufacturing Description: The OSD Continuous Manufacturing tour at INTERPHEX will provide a comprehensive overview of equipment/unit operations that comprise continuous tablet and capsule production, including feeding, mixing, granulation, drying, compression and coating. Tour participants will observe state-of-the-art continuous processing equipment on display and in demonstration, as well as receive dedicated presentations and insight into the latest advances in Continuous Manufacturing from the industry’s most experienced equipment experts. This year, the tour will also highlight the integration of automation required with Continuous Manufacturing as well as the alternate methodology of material handling associated with Continuous Manufacturing.

IPS Packaging & Inspection Technologies Tours

Tour Leaders: Kevin Swartz, Leonard Pauzer, Jr., Tina Gushue, and Stefani Scoblick
Exhibitors include: Dividella AG, IMA North America, Inc., MG America,
Seidenader Maschinenbau GmbH, and Wilco, AG

Packaging & Inspection Description: The Packaging and Inspection tour at INTERPHEX will focus on new and innovative technology related to inspecting and packaging presented by the industry leaders.

INTERPHEX/BPI Poster Hall and Awards

Tuesday/Wednesday, March 21-22: 10:00am – 5:00pm
Thursday, March 23, 10:00am – 3:00pm
Near Booth 3861, Exhibit Hall

Poster sessions at INTERPHEX will highlight new technologies and equipment, novel methodologies and state-of-the-art knowledge and innovation. Posters will be showcased throughout the three-day event. A distinguished panel will select two finalists from poster categories, and winner(s) will be chosen on March 21 during the Opening Ceremony.

INTERPHEX Passport Program

Tuesday, March 21st, 10:00am to Thursday, March 23rd, 12:00pm, Exhibit Hall
Receive your passport at Registration or the Information Desks and visit and engage with all participating sponsors at their booths to get your passport stamped. Once you’ve completed your passport submit it to the Information Desk for your chance to win! At the end of the show INTERPHEX Show Management will choose at random completed passports and announce the winners via social media.

View Official Rules and Regulations

NEW: PDA Roundtable Discussions

Tuesday/Wednesday, March 21-22, 10:00am – 5:00pm
Near Booth 3861, Exhibit Hall

PDA continues to deliver the latest in bio/pharmaceutical science, innovation and technology. Industry experts gather for Roundtable Discussions, right on the show floor. Registration is required.

NEW: Germfree Adaptive Biopharma Production Suite

Tuesday/Wednesday March 21-22: 10:15am-4:45pm
Thursday, March 23: 10:15am-2:45pm
Germfree Booth 3961, Exhibit Hall

Germfree will exhibit a fully functional cGMP cleanroom housed in a 53' (16 m) trailer. This innovative platform is optimal for a range of biopharmaceutical production needs including Monoclonal Antibodies, Therapeutic Proteins, Viral Vector and Live Virus Vaccines. Adaptive Trailers offer flexible cleanroom space that is easily configured to required ISO grades as well as Biological Safety Levels up to BSL-3.

NEW: India Pavilion

Tuesday/Wednesday, March 21-22: 5:00pm – 5:00pm
Thursday, March 23: 10:00am-3:00pm
Booth 1310 & 1316, Exhibit Hall

Augmented Reality/Virtual Reality “Cave”

Tuesday/Wednesday, March 21-22: 5:00pm – 5:00pm
Thursday, March 23: 10:00am-3:00pm
Booth 3664, Exhibit Hall

2015 Winner of the INTERPHEX Best New Product/Service. Visit the AR/VR “Cave” to see for yourself how Smart Glasses and Suite empowers biopharmaceutical manufacturing operators and engineers to help make informed decisions, greatly improve communication and speed up the troubleshooting process.

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