Interphex 2014 Educational Sessions - Pharmaceutical Technology

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Interphex 2014 Educational Sessions

Interphex 2014

Special educational programming hosted by Pharmaceutical Technology and BioPharm International

BioPharm International

PharmTech

 


Join Pharmaceutical Technology and BioPharm International to hear about the latest advances in hot melt-extrusion processes, continuous manufacturing for solid dose drugs and biologics, high-potency finished drug manufacturing, cleaning validation, contract manufacturing, serialization, and modular manufacturing systems. Participate in Q&A sessions to get answers to your manufacturing challenges. Innovation Center sessions will be held on Stage 2 in the Innnovation Center.

Session topics:
Advances in Hot-Melt Extrusion Manufacturing
Continuous Manufacturing for Solid Dose Drugs
High-Potency Manufacturing for Finished Drugs
Implementing Effective Cleaning Validation Programs
The Right Business Decisions In Light of the Drug Quality and Security Act
Getting More Out of the Contract Services Relationship
Continuous Manufacturing for Biologic Drugs
Modular Biopharmaceutical Manufacturing Systems

Admission to the Innovation Center sessions is free to visitors with an exhibit hall pass. Receive a complimentary exhibit hall pass when you register at www.INTERPHEX.com/PharmTech

Don't miss Jim Miller's annual "state of the CMO industry" address. This Specialty Forum, The Changing Contract Services Landscape, is scheduled for March 19 at 9 am. See below for details.


Specialty Forum

Wednesday, March 19, 9 am –10 am, Room 1E21
Special session, sponsored by Pharmaceutical Technology and BioPharm International
The Changing Contract Services Landscape

Jim MillerThe contract services industry finds itself in a different place than it did one year ago. The favorable financial environment is creating opportunities for CMOs and CDMOs to raise capital to fund investments and acquisitions, and in some cases launch themselves as public companies. At the same time, a growing number of CMOs and CDMOs are diversifying their business models by venturing into proprietary products.

The robust financial markets have also been good news for the demand side of the contract services equation. The in-flow of capital has meant that bio/pharma companies have substantial resources for R&D spending, and there are strong signs that companies are refilling the pipeline with more early development candidates.

This year's presentation will update the picture of the evolving contract services landscape. Our themes will include the consolidation of the CMO universe; the evolution of new service combinations to fit the changing R&D requirements of bio/pharma companies; and the industry's outlook for the next few years.

Presenter: Jim Miller, president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report


Innovation Center Educational Sessions

Tuesday, March 18, 10:30 am –11:15 am
Innovation Stage 2, Exhibit Hall
Advances in Hot-Melt Extrusion Manufacturing
Moderator: Jennifer Markarian, Manufacturing Editor, Pharmaceutical Technology

Hot-melt extrusion is a continuous manufacturing process that can be used to produce solid-dosage formulations and combination drug-devices, as well as enhance solubility for poorly soluble drugs. This session will discuss how twin-screw extrusion works and share best practices and practical applications.

Presentation:
Twin-screw extrusion theories, tips, and test results
Presenter: Charlie Martin, President, Leistritz Extrusion

Presentation:
Trends in Polymer Extrusion and Shaping Technologies
Presenter: Tony Listro, Managing Director, Foster Delivery Science

Admission to the Innovation Center sessions is free to visitors with an exhibit hall pass. Receive a complimentary exhibit hall pass when you register at www.INTERPHEX.com/PharmTech


Tuesday, March 18, 11:15 am –noon
Innovation Stage 2, Exhibit Hall

Continuous Manufacturing for Solid Dose Drugs
Moderator: Jennifer Markarian, Manufacturing Editor, Pharmaceutical Technology

Continuous solid-dosage manufacturing offers the potential for improved quality, higher production efficiency, and smaller, more flexible equipment. This session will discuss current and future benefits of and challenges in implementing continuous processes. It will also explore keys for success in integrating multiple process units into a control system with time-aligned process inputs to enable feed-back and feed-forward controls.

Presentation:
Visions for Continuous Solid-Dosage Manufacturing
Presenter: Doug Hausner, Engineering Research Center for Structured Organic Particulate Systems at Rutgers, the State University of New Jersey

Presentation:
Enabling Integrated System Control in Continuous Manufacturing

Presenter: Pamela Bruen Docherty, Life Sciences Industry Manager - USA, Siemens

Admission to the Innovation Center sessions is free to visitors with an exhibit hall pass. Receive a complimentary exhibit hall pass when you register at www.INTERPHEX.com/PharmTech


Tuesday, March 18, 1:30 pm –2:15 pm
Innovation Stage 2, Exhibit Hall
High-Potency Manufacturing for Finished Drugs
Moderator: Rita Peters, Editorial Director, Pharmaceutical Technology/BioPharm International

Highly potent drugs pose special hazards for manufacturing personnel and facilities. Special measures are required in order to define hazard levels, minimize cross-contamination, ensure containment, and meet Good Manufacturing Practices. This session will examine the risks inherent in handling and manufacturing high potency pharmaceuticals and review systems, processes, best practices, and strategies required for these environments.

Presentation:
Potent Manufacturing of Solid Oral Dosages Utilizing Dry Granulation

Presenter: Shantanu Sonparote, Associate Process Development Engineer, Manufacturing, Science & Technology, AbbVie Inc.
Many small molecules, such as anti-cancer and anti-viral molecules, require a very low dose and are highly potent. Potent compounds require unique treatment throughout the manufacturing process in order to ensure high quality drug products; dry granulation via roller compaction is a unit operation that lends itself well to potent ingredients. A case study will go through an example roller compaction process of a highly potent compound that will highlight both the challenges of potent processing, and the solutions utilized to overcome these challenges.

Presentation:
Using Shared Facilities for Manufacturing High Potency Finished Drugs

Presenter: Stephanie A. Wilkins, PE, PharmaConsult US, Inc.
As more and more high potency drugs are being developed, manufacturing these products in shared facilities is necessary to keep costs down for patients. Find out which products can be safely manufactured in shared facilities as well as how the proposed EMA GMP revisions will impact the need for dedicated facilities.

Admission to the Innovation Center sessions is free to visitors with an exhibit hall pass. Receive a complimentary exhibit hall pass when you register at www.INTERPHEX.com/PharmTech


Tuesday, March 18, 2:15 pm –3 pm
Innovation Stage 2, Exhibit Hall
Implementing Effective Cleaning Validation Programs
Moderator: Rita Peters, Editorial Director, Pharmaceutical Technology/BioPharm International

This session will explore methods, practices, and programs to efficiently and effectively implement cleaning validation for facilities that manufacture pharmaceutical and biological products. Speakers will address visual inspection methods, as well as a science-driven risk-based guide for cleaning validation.

Presentation:
Cleaning Validation: Life Cycle, Parameters, and Qualifying Personnel

Presenter: Richard Forsythe, Forsyth Pharmaceutical Consulting
Learn about the latest challenges in cleaning validation including the life cycle approach to cleaning, the need for critical cleaning parameters for process capability, and qualification of personnel for cleaning activities.

Presentation:
The New ISPE Cleaning Guideline: Science- and Risk-based Approaches to Cleaning Development
Presenter: Andrew Walsh, Principal, PharmaClean Group, LLC
The new ISPE Cleaning Development and Cleaning Validation Guide is scheduled for completion in early 2014 and will apply to the development and verification of cleaning processes for all Health, Medical, Cosmetics and Consumer products. This presentation will provide an overview of the guideline elements generally, and provide some specific examples of how some very well known and accepted scientific concepts have been applied to cleaning process development and verification. In many cases the new applications provide the first Science, Risk and Statistics-based approaches to problem solving in cleaning. Selected topics to be discussed include: Risk-MaPP, the "Science- and Risk-based" Approach to cleaning setting acceptance criteria, cleaning process development, and process analytical technology in cleaning.

Admission to the Innovation Center sessions is free to visitors with an exhibit hall pass. Receive a complimentary exhibit hall pass when you register at www.INTERPHEX.com/PharmTech


Wednesday, March 19
10:30 am –11:15 am
Innovation Stage 2, Exhibit Hall
Track and Trace/Serialization: The Right Business Decisions In Light of the Drug Quality and Security Act (DQSA)
Moderator: Rita Peters, Editorial Director, Pharmaceutical Technology/BioPharm International

The Drug Quality and Security Act of 2013 (DQSA), which was enacted to ensure that prescription drugs are safe, effective, and of high quality, calls for a phased implementation of electronic tracking systems to track pharmaceutical products, down to the package level.
In this session, William "Bill" Fletcher, an expert with more than 20 commercial serialization and traceability project for global life sciences companies, will provide an overview of understanding the requirements of the new law. In addition, he will discuss aligning the DQSA with requirements in other countries, including Brazil, China, European Union countries and more; business benefits of serialization and traceability; and lessons learned from implementing serialization for over 20 global life sciences companies.

Presenter: William "Bill" Fletcher, Managing Partner, Pharma Logic Solutions, LLC

Admission to the Innovation Center sessions is free to visitors with an exhibit hall pass. Receive a complimentary exhibit hall pass when you register at www.INTERPHEX.com/PharmTech


Wednesday, March 19, 11:15 am –noon
Innovation Stage 2, Exhibit Hall
Getting More Out of the Contract Services Relationship
Moderator: Jim Miller, president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report

The relationship between a client company and its CMO/CDMO is often a rocky one. Misunderstandings and unmet expectations are common, and trust between the parties can erode quickly. Relationship problems can stem from multiple sources but more often than not the problems can be traced to factors like the client's inadequate understanding of the development process, too little information being exchanged, unrealistic expectations about what can be delivered within a certain timeframe and budget, and conflicts between the client's cost concerns and the CDMOs need to make a profit.

This panel discussion will draw on the broad experience of CDMO/CMO executives to identify ways that clients can improve their outcomes with their contract service providers and get more value out of their outsourcing relationships.

Panelists to be announced

Admission to the Innovation Center sessions is free to visitors with an exhibit hall pass. Receive a complimentary exhibit hall pass when you register at www.INTERPHEX.com/PharmTech


Wednesday, March 19, 1:30 pm –2:15 pm
Innovation Stage 2, Exhibit Hall
Continuous Manufacturing for Biologic Drugs
Moderator: Jennifer Markarian, Manufacturing Editor, Pharmaceutical Technology/BioPharm International

Continuous manufacturing is being used in upstream biopharmaceutical production, and industry is now exploring connecting upstream and downstream operations to gain further advantages of fully continuous processing. This session will explore current and future challenges in continuous biopharmaceutical manufacturing.

Presenters:
John Bonham-Carter, VP Business Development, Refine Technology
Stéphanie Dubois, Cell Culture Lab Manager & Applications Specialist, ATMI

Admission to the Innovation Center sessions is free to visitors with an exhibit hall pass. Receive a complimentary exhibit hall pass when you register at www.INTERPHEX.com/PharmTech


Wednesday, March 19, 2:15 pm –3 pm
Innovation Stage 2, Exhibit Hall  
Modular Biopharmaceutical Manufacturing Systems
Moderator: Jennifer Markarian, Manufacturing Editor, Pharmaceutical Technology/BioPharm Interantional

Biopharmaceutical manufacturing is expected to move from large, single-product facilities to flexible, modular, multi-product facilities. This session will explore new processing unit and facility designs that enable new production methods.

Presentation:
Standardized Modular Facility Solutions for Biopharmaceutical Manufacturing
Presenter: Pär Almhem, President, ModWave and Modular Partners

Presentation:
How to Rapidly Enable Flexible Biomanufacturing in a New Or Existing Facility
Presenter: Parrish Galliher, Founder and CTO, Xcellerex, a GE Life Sciences Healthcare Co.

Admission to the Innovation Center sessions is free to visitors with an exhibit hall pass. Receive a complimentary exhibit hall pass when you register at www.INTERPHEX.com/PharmTech


 

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