Keynote Series

INTERPHEX launched the Keynote Series with Pharmaceutical Technology and BioPharm International to feature industry experts delivering insight on key industry themes and challenges.

2019 Program

Tuesday, April 2: 10:30am – 12:00pm

Designing Continuous Manufacturing Processes for Solid-Dosage Drugs: Development to Commercial Scale

Several solid-dosage drugs are now approved for manufacture using continuous processes, and early adopters and equipment manufacturers have been making progress in addressing engineering challenges. Two of the potential advantages of continuous manufacturing compared to batch manufacturing are rapid development and flexibility in scale. This panel discussion will consider what benefits are being realized and what challenges are arising as continuous processes are commercialized. Experts will discuss best practices for and challenges in tech transfer and scale-up/scale-out from development to commercial scale.
Moderator: Jennifer Markarian, manufacturing editor, Pharmaceutical Technology

Panelists:
Doug Hausner, associate director for the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), Rutgers University
José Luis Santos, head of drug product continuous manufacturing, Hovione
Sharon Nowak, global business development manager, Coperion KTron
Gregory Connelly, director in formulation development and drug product continuous manufacturing lead, Vertex Pharmaceuticals

 

Tuesday, April 2: 1:30pm – 3:00pm.

3D Printing Applications in Pharma

Three-dimensional printing (3DP)—also called additive manufacturing—is increasing in use in a range of healthcare industries, for printing customized prosthetics, for example, and for making models doctors can use to plan a surgery. 3DP also offers a new design freedom for bio/pharmaceutical manufacturing—whether for “printing” a solid-dosage drug or for creating a piece of equipment for bio/pharmaceutical laboratories or manufacturing facilities. 3DP is being used commercially in the pharmaceutical industry today, and additional uses are being investigated for the processes and equipment of tomorrow.
Moderator: Jennifer Markarian, manufacturing editor, Pharmaceutical Technology

1:30pm – 2:15pm

3D Printing of Solid-Dosage Drugs: Current Capabilities and Future Vision

Aprecia Pharmaceutical’s Spritam tablets became the first 3D-printed drug approved by FDA in August 2015. The tablets are made using the company’s proprietary ZipDose Technology platform. This session will describe current capabilities as well as the potential for using 3DP for personalized medicine.
Speaker: Timothy S. Tracy, PhD, CEO of Aprecia Pharmaceuticals

2­:15pm – 3pm

Accelerating Additive Manufacturing for Bio/Pharma

In 2017, GE Healthcare opened a 3D printing lab at its technology center in Uppsala, Sweden to investigate how 3DP can speed the launch of innovative products. A 3D-printed chromatography column, for example, was custom-designed for a biopharmaceutical purification process. This session will discuss uses of 3DP in bio/pharma.
Speaker: Christel Fenge, head of R&D for GE Healthcare, Uppsala, Sweden

 

Wednesday, April 3: 10:30am – 12:00pm

Meeting Bioprocessing Manufacturing Capacity Demands

Capacity demands for biologic-based drugs are shifting due to high-volume demands for blockbuster and biosimilar drugs, and smaller-volume demands of targeted therapies. How is the industry responding to production-related challenges?
Moderator: Rita Peters, editorial director, BioPharm International and Pharmaceutical Technology

10:30am – 11:00am

State of the Bioprocessing Industry: Global Shifts in Capacity, Innovations, and Trends in Outsourcing

Learn about research findings and trends in capacity demands and the application of bioprocessing technologies gleaned from a comprehensive survey of industry practices and perceptions. The discussion will include the role contract manufacturing organizations in meeting the production needs of biopharma companies.
Speaker: Eric Langer, president and managing partner, BioPlan Associates

11:00am – 12:00pm

Solutions for Efficient, Cost-Effective Biologic Drug Manufacturing

Following lengthy research and development phases, drug companies are incentivized to get drugs to market quickly and seek efficient, cost-effective ways to expedite drug manufacturing processes. Equipment and facility manufacturers are introducing technology advances and contract manufacturers are offering alternatives to inhouse manufacturing. A panel of bioprocessing experts will discuss and debate how technologies and innovative manufacturing strategies can be implemented to advance the efficiency and cost-effectiveness of biomanufacturing processes. Topics include expedited process development, single-use systems, flexible facilities, scale out of multiplexed single-use bioreactors, biopharma/contract manufacturing arrangements, and more.

Panelists:
Eric Langer, president and managing partner, BioPlan Associates
Brady Cole, vice-president, applications, ABEC
Madhu Raghunathan, product strategy leader for BioProcess Hardware, GE Healthcare
Mike Felo, director, downstream process integration, next generation processing, MilliporeSigma
Steve Perry, senior director, manufacturing sciences, Catalent Biologics
Rick Morris, senior vice-president, research and development, Pall Biotech

 

Wednesday, April 3: 1:30pm – 3:00pm

Minimizing Contamination in Aseptic Manufacturing

Experts look at new technologies, approaches, and services that are preventing contamination, recalls, and regulatory noncompliance in a crucial area of drug manufacturing.
Moderator: Agnes Shanley, senior editor, Pharmaceutical Technology

1:30pm – 2:00pm

Aseptic Processing: Industry Trends and Challenges

Jim Agalloco, principal, Agalloco Associates

2:15pm – 2:40pm

Tech Talk: Top Issues and How New Technologies and Services Address Them

Learn about current industry challenges related to aseptic processing and possible solutions including new technology advances, supply chain integration, and enhanced roles for CDMOs.

Panelists:
Chris Procyshyn, CEO, VanRx
Jo Anne Jacobs, fellow and manufacturing technology specialist, Catalent
Nicholas Zasada, director of process development and manufacturing, Vetter Development Services USA, Inc.
Paul Lopolito, technical service senior manager, Steris Corporation, Life Science Formulated Chemistries
Arnab Ganguly, scientist and technology manager, IMA Life North America, Inc.
Moderator: Jim Agalloco, principal, Agalloco Associates

2:40pm – 3:15pm

Regulatory Issues and Innovation

Experts will debate key issues related to aseptic processing and regulatory oversight including the following:

  • Ending the Catch 22 of aseptic technology innovation: How can regulators encourage the use of innovative technologies when they haven’t yet been mentioned in a new drug application or other filing?
  • Annex I: Does it signal deeper misunderstandings of basic concepts and science on the part of regulators, and what can be done about it?

Panelists:
Jim Agalloco, principal, Agalloco Associates
Chris Procyshyn, CEO, VanRx
Jo Anne Jacobs, fellow and manufacturing technology specialist, Catalent
Nicholas Zasada, director of process development and manufacturing, Vetter Development Services USA, Inc.
Paul Lopolito, technical service senior manager, Steris Corporation, Life Science Formulated Chemistries
Arnab Ganguly, scientist and technology manager, IMA Life North America, Inc.
Moderator: Agnes Shanley, senior editor, Pharmaceutical Technology

We use cookies to operate this website and to improve its usability. Full details of what cookies are, why we use them and how you can manage them can be found by reading our Privacy & Cookies page. Please note that by using this site you are consenting to the use of cookies.