Growing Acceptance of Real-Time Monitoring

Frank Panofen, Particle Measuring Systems

Seeing the Light

Anders Vinther, PhD

Getting Biosimilars Right the First Time

Barbara Rellahan, Amgen

Knowledge Grows for mAb Development

Martijn van der Plas, PhD, Medicines Evaluation Board, and Michael De Felippis, PhD, Eli Lilly

A Wealth of New Tech Possibilities

Scott Bozzone, PhD, Pharm Lifecycle Validation LLC

A Tale of Two Vials

Rebecca Stauffer, PDA

Strategies for Reducing Data Integrity Challenges

Rebecca Stauffer, PDA

3-D Printing and Biopharmaceutical Manufacturing

Lina Genovesi

PDA Responds to Annex 1 Revision

Rebecca Stauffer, PDA

Container Closure Integrity Requires Adaptation

Dominick DeGrazio, PhD, Janssen R&D, LLC

RMAT Program Raises a Few Questions

Austin Caudle, IQVIA

Amgen Team Brings Expertise to Taiwan Chapter

Yi-Yin Lu, Secretary General of PDA Taiwan Chapter

Running the Numbers for Analytical Similarity

Beverly Ingram, Pfizer

Make New Buddies in Berlin

Rebecca Stauffer, PDA

Glass Versus Cyclic Olefin Polymers

James McCaw, West Pharmaceutical Services, Inc.

New Drugs Need Agile Biomanufacturing

Rebecca Stauffer, PDA

Speaking the Language of GMP

Rebecca Stauffer, PDA

PDA Celebrates Ten Years of ATMP Conferences

Rebecca Stauffer, PDA

Know Your Numbers for Analytical Similarity

Emanuela Lacana, PhD, U.S. FDA

ATMPs: What a Difference a Year Can Make

John Geigert, PhD, BioPharmaceutical Quality Solutions

Moving the Patient to the Forefront

David Haase, Genentech, and Manfred Maeder, PhD, Novartis

Packaging Critical to Success of Drug Products

Diane Paskiet, West, and Lei Li, Eli Lilly

Cell and Gene Therapies Present Challenges, Promise

Joshua Eaton, PDA

Volunteering Opens Doors for Student Chapter

Dahlim Kim and Jasmine Tat, Keck Graduate Institute

Sterilizing Grade Filters and PUPSIT

A Statement From Four Filter Manufacturers

Novel Manufacturing Tech Drives Novel Product Development

Rebecca Stauffer, PDA

Glass Along the Value Chain

Claudia Heinl, PhD, Schott

Awareness Critical for Container Closure Components

Honoring PDA’s Female Volunteer Leaders

Martin VanTrieste

Smoke Signals

Tony Pavell, Fresenius Kabi

New Approach Suggests Continuous Lyophilization is Possible

Pieter-Jan Van Bockstal, Ghent University, Jos Corver, RheaVita, and Thomas De Beer, Ghent University

PDA Staff Try a Hand at Aseptic Processing

Marilyn Foster, PDA

Seeing the Hidden

Rebecca Stauffer, PDA

Korea Chapter Inaugurates New KPDA Hall

PDA Korea Chapter

H20 Requirements for Superheated Sterilization

Rebecca Stauffer, PDA

Changes to USP Council of Experts

Rebecca Stauffer, PDA

New Tech Disrupts Traditional Aseptic Processing

2018 PDA Annual Meeting speakers

Adapt Your Nest-and-Tub System as the Industry Evolves

Gregor Deutschle, SCHOTT

New Trends Require Investment from Vaccine Makers

Cristiana Campa, GSK Vaccines, and Nancy Cauwenberghs, MSD

High Regulatory Expectations for Biosimilars

Stephan Krause, PhD, AstreZeneca Biologics, Emanuela Lacana, PhD, U.S. FDA, Jens Schletter, PhD, Sandoz, and Rebecca Stauffer, PDA

More Opportunities to Grow Your Network

Rebecca Stauffer, PDA

Teamwork Crucial to SUS Sterilization Validation

Polly Hanff, Saint-Gobain Performance Plastics

Formalizing a Risk Assessment for Excipients

Frithjof Holtz, Merck KGaA, Darmstadt, Germany

Extractables Testing of Aluminosilicate and Borosilicate Glass Containers

Daniel Kramer, Robert Schaut, PhD, Ela Bakowska, Misty Riesbeck, Alex Thomas, Steven Tietje, Corning Incorporated

PDA Prefilled Syringes Exhibition Draws Crowd

Rebecca Stauffer, PDA

Student Chapter Shows Enthusiasm for Industry

Denyse Baker, PDA

4 Capabilities to Operationalizing Resilience

Amy D. Wilson, PhD, Biogen

Achieve True Manufacturing Reliability

Hal Baseman, ValSource, and Brett Duersch, Merck and Co.

Chapter Learns About Future of Facility Design

Anthony Grilli, Focus Scientific

Quality and Innovation are Not Incompatible

Janmeet Anant, MilliporeSigma

Quality: One Question, Many Answers

Stephanie Gaulding, DPS Engineering

Collaboration Through Mutual Reliance Brings FDA and EMA to the Table

Rebecca Stauffer, PDA

Monitor Viable Air with Single-Use, Real-Time Tech

Frank Panofen, PhD, Particle Measuring Systems

Disruptive Change is on the Horizon

Tia Bush, Amgen

Flexibility Needed for PAC

Rebecca Stauffer, PDA

Regulators Tackle Tough Micro Questions on Panel

Rebecca Stauffer, PDA

New PDA Task Force Targets Big Data

Michele D’Alessandro, Merck & Co., and Aaron Goerke, F. Hoffmann-La Roche Ltd.

Brazil Chapter Offers Hands-On Aseptic Training

Wolfgang Harry Löscher Filho, Libbs Farmacêutica, Brazil Chapter Secretary

Cracking the Challenges of Glass Packaging

Roger Asselta, Genesis Packaging Technologies

Record Scholarships Awarded at NE Chapter Dinner

Steven Jones, Validation Support, New England Chapter Communication Commitee Chairperson Member at Large

CFDA Encouraged to Review PDA Docs

Rebecca Stauffer, PDA

PDA Staff Gown Up for Site Visit at Pilot Plant

Marilyn Foster and Jahanvi (Janie) Miller, PDA

Millennials: How Manufacturers are Training the Next Generation

Rebecca Stauffer, PDA

Worst-Case Analysis of Cell Growth in SUS

Samuel Dorey, Sartorius

Networking Lights Up PDA/FDA JRC Exhibit Hall

Rebecca Stauffer, PDA

PDA on the Move

Rebecca Stauffer, PDA

Isolator Surfaces and Contamination Risks to Personnel

Richard Denk, SKAN AG, Andreas Flueckinger, MD, Roche, Hirokazu Kisaka, Takeda, Reinhold Maeck, PhD, Boehringer Ingelheim, Lars Restetzki, PhD, Roche, Andreas Schreiner, PhD, Novartis, Rico Schulze, Landesdirektion Sachsen

AIDC is a Sign of Things to Come: Part II

Napoleon Monroe, New Directions Consulting

AIDC is a Sign of Things to Come: Part I

Napoleon Monroe, New Directions Consulting

A Risk Assessment is an Opportunity Assessment

David Hubmayr, CSL Behring

PDA and IFPMA Foster Discussion on PAC

Ursula Busse, PhD, Novartis

Prefilled Syringe Manufacturing Moves Away from Hands-On Approach

J. Martin Bultmann

Five Keys to Manufacturing Success

R. J. Filannino, Alice Redmond, and Richard Tree, Commissioning Agents

Two Views on Packaging from Prefilled Exhibitors

Universe of Prefilled Syringes Exhibitors

One Company’s Approach to Rapid Micro Methods

Mousumi Paul and Scott Hooper, Merck Sharp and Dohme Corp.

Ireland Chapter Provides Once in a Lifetime Trip

Shane Costigan

New Realities for Prefilled Syringes

Mathias Romacker, Pfizer, Conference Scientific Program Planning Committee, with Rebecca Stauffer, PDA

Industry Awaits Annex 1 Revision

Walter Morris, PDA

The QC Lab of the Future

Tim Amudala, Biogen, Lotte Rosendal, Biogen, Rick Mineo, Encova Consulting, Sachin Patel, Biogen, Christy Mounts, Biogen, and Lou Killian, Kneat Software

Novel Drug Products Drive New Views on Suitability

Diane Paskiet, West, and Ronald Iacocca, PhD, Eli Lilly and Company

Visual Inspection Faces Changing Environment

John D. Ayres, MD, Eli Lilly and Company

One Simple Way to Manage Aseptic Risk Assessments

Guenther Gapp, Independent Consultant

Four Steps to Ensuring Data Integrity for BET

Jennifer Farrington, PhD, Associates of Cape Cod, Inc.

Company Sees Success With Automated Endotoxin Testing

Scott Kaszuba, Pfizer

Why the Surface is Critical to Disinfection Testing

James Polarine, Jr., and David Shields, STERIS

PQS: An Effective Lever for Managing PACs

Anders Vinther, Sanofi Pasteur, Emma Ramnarine, Genentech/Roche, Kevin O’Donnell, Irish Health Products Regulatory Authority

The Future of Cell and Gene Therapies is Here

Austin Caudle, Metabolon, Inc.

The Cost of Microbial Control

Edward Tidswell, PhD, Merck, and Walid El Azab, Steris

A Stepwise Approach to Effective Data Management and Analysis

Gilberto Dalmaso, PhD, Particle Measuring Systems

Women in Biotech Panel Offers Career Advice for All Sexes

Fabio De Martino, PDA West Coast Chapter President-elect, F. Hoffmann La-Roche, and Beth C. Keij, Sangamo Therapeutics

Difficult-to-Inspect Drugs Require New Processes

Rick Watson, Merck & Co., Inc.

India Chapter Holds Successful Biologics Workshop

Biny Joseph, PDA India Chapter Coordinator

Can Single-Use Components Be Commodities?

Sabrina Restrepo, PhD, Merck, and Christopher J. Smalley, PhD, ValSource

When Microbiologists Collaborate, Great Things Happen

Marsha Steed (Hardiman), ValSource

Build Your Network at the PDA/FDA JRC

Rebecca Stauffer, PDA

Regulatory Submissions: No Longer Paper-Based

Matthew M. Lowe, MasterControl

OPQ Establishes Manufacturing Science CoE

Kurt Brorson and Sau L. Lee, U.S. FDA

PDA Summer Reading for 2017

Rebecca Stauffer, PDA

A Maturing Model of Quality

Jacqueline Kunzler, PhD, Baxter International Inc.

Industry Expert Weighs in on Quality Metrics

Rebecca Stauffer, PDA