PDA Comments: Viral Testing for Gene Therapies

Rebecca Stauffer, PDA

Rapid Micro Methods Carry Potential

Tony Cundell, PhD, Microbiological Consulting, and Michael Miller, PhD, Microbiology Consultants

PDA Addresses LER in TR, Forthcoming Book

Rebecca Stauffer, PDA

NE Chapter Elects New Board, Plus Cold Storage

Henry Brush, Zagfen, New England Chapter Member-at-Large

Our Data Integrity Journey Has Only Just Begun

Jackie Veivia-Panter, Legend Biotech

The Challenges of Visually Inspecting IV Bags

Florian Krickl, Vitronic

Implementation Proves Parametric Release Possible

James Assini, Sanofi

Viruses on the Surface

Jennifer Loughman and Paul Lopolito, STERIS

Industry Eyes Future of Visual Inspection

John Shabushnig, PhD, Insight Pharma Consulting; Markus Lankers, PhD, MIBIC; John Ayres, MD, Pharma Safety Solutions; Roy Cherris, Bridge Associates; Robert Miller, Pfizer; Romain Veillon, GSK Vaccines; and Rick Watson, Merck

Big Data is Here to Stay

Aaron Goerke, PhD, F. Hoffmann-La Roche AG, and Michele D’Alessandro, Merck & Company, Inc.

Student Chapter Gains Stem Cell Insights

Kathryn MacDonald, Middlesex Community College

Vaccines, Biosimilars Share Commonalities

Peter Makowenskyj, G-CON Manufacturing

Can the Power of Viruses be Harnessed for Good?

Brian Hawkins, PhD, Pluristyx, Inc.

Change is in the Air for Packaging Components

Rebecca Stauffer, PDA

Biopharma Offers New Opportunities

Cristiana Campa, GSK, and Michael De Felippis, Eli Lilly and Company

A Roadmap to a Continuous Control Strategy

Per Vase, PhD, NNE

PUPSIT & the Proposed Annex 1 Revision

Hal Baseman, ValSource

Expand Your Network and Have Fun!

Rebecca Stauffer, PDA

Thanks for the Warning Letter: Part II

Steven Lynn, Lynn Consulting

Response to "Standing Guard"

Kevin L. Williams, bioMérieux

Global Regulators Partner for Greater Patient Access

Ursula Busse, PhD, Novartis

Take Cell and Gene Therapy Supply Challenges by the Horn

Michael Blackton, Adaptimmune

Are You Up to Speed with Pharma’s Evolving Landscape?

Magaly E. Aham, Takeda Pharmaceuticals

Growth Promotion Testing For EM

Brendan Tindall, biomerieux, and Graham Vesey, Regeneus

Data Integrity Validated as Key Issue

Bruce Loxley, GSK Vaccines, PDA Singapore Chapter Member-at-Large

Alternative to LAL Gains Ground

Stephenie Overman

Regulatory Concerns Drive New Developments in Glass Packaging

Rebecca Stauffer, PDA

An Overview of Container Closure Integrity

Qingyu Zeng, PhD, West Pharmaceutical Services, Inc.

Current Perspectives on the Monocyte Activation Test

Djikolngar Maouyo, Pyrodex

Innovative Tech Drives Drug Shortage Solutions

Robert Guidos, Corning

Are You (and Pharma) Ready for the Future?

Karen Walker, Seattle Genetics, and Tia Bush, Amgen

India Chapter Gets Hands-On with CCI Tech

Biny Joseph, Vienni Training and Consulting

EMA's Amsterdam Move Reflects Larger Trend

Toni Manzano, bigfinite

Holistic Verification Requires a New Mindset

David Hubmayr, CSL Behring

Industry and Regulators Convene to Address Vaccines Challenges

Industry 4.0 and Drug Manufacturing

Walter Alexander

FDA's ORA Realignment, MRA, NIPP, Concept of Operations: How it All Fits Together

Rebecca Stauffer, PDA

Hidden Contamination in Starting Materials

Annette Kirsch, PhD, Merck KGaA

Process, Interrupted

Fatima Hasanain, Polymer Materials Specialist, Nordion (Canada) Inc.

Thanks for the Warning Letter: Part I

Steven Lynn, Lynn Consulting, LLC

Glass Breakage in Pharmaceutical Packaging

Carina Bronnbauer, PhD, SCHOTT

Risk Management Shines Light on ICH Q12 Use for Biologics

Jose C. Menezes, PhD, 4Tune Engineering

PDA Forms New Chapter in Pacific Northwest

Rebecca Stauffer, PDA

Modular Manufacturing Begins to Take Hold

David Pittman

West Coast Chapter Hosts Women in Biopharma Panel

Lori Richter, ValSource

Future Challenges in Visual Inspection Processes

John Shabushnig, PhD, Insight Pharma Consulting, and Markus Lankers, PhD, Mibic GmbH

Big Data, Pharma 4.0 and Legacy Products

Jana Spes, Boston Biomedical, and Wayne Levin, Predictum

Big Data: The Panacea for Pharma’s Ills?

Khan Lau, Promedica International

Build Your CCI Knowledge Base Through Data, Tech

Jaime Cobo, WILCO AG

Meet the PDA Letter’s First Intern

Aneeta Mathur-Ashton, American University

Hot Read: GMP in Practice

Rebecca Stauffer, PDA

Exciting New Changes are Coming to Pharma

Melissa Seymour, Biogen, Inc., and Ghada Haddad , Merck & Co./ Merck Sharp & Dohme

Pharmacy Student Sees Future of Pharma in Berlin

Aoife Clancy, Trinity College Dublin

Risk-Benefit Analysis More of NCA Scope

Rebecca Stauffer, PDA

New Perspectives on Freeze-Drying

Thomas Beutler, GEA, and Yves Mayeresse, GSK

Southeast Chapter Meeting Pairs Wine, Decon Tech

John Groth, SKAN US

Standing Guard

John Dubczak, Charles River Laboratories

Endotoxin Testing Using Recombinant Reagents

Karolina Heed, Hyglos - a bioMérieux company

A Deep Dive into Pharmacopeial Harmonization

Rebecca Stauffer, PDA

Deep Learning in the Information Swamp

Heino Prinz, Rommelag

Does QRM + RMM = Better EM?

Dalmaso Gilberto, PhD, and Lisa G. Lawson, Particle Measuring Systems

Going Beyond Patient Preference

Nic Bowman, Pfizer

Build Connections at Two PDA Events

Rebecca Stauffer, PDA

New Trends, New Challenges for BET

Jay Bolden, Eli Lilly and Company, and Ned Mozier, PhD, Pfizer

Drug Delivery Combination Products Go “Viral”

Lee Leichter, P/L Biomedical

What Annex 1 Means for Sterilization and Moist Steam

Walid El Azab, STERIS Life Science

Data Integrity in the Age of Metadata and Big Data

Toni Manzano, bigfinite

Biologics Packaging Presents Risks

Alessandro Morandotti, Ompi

Draft Annex 1 Separates Cleaning and Disinfection

James Tucker, Ecolab Life Sciences

A Wealth of New Micro Regulations

Michael Miller, PhD, Microbiology Consultants

Revised USP Micro Chapters Address Changing Technologies

David Hussong, PhD, Eagle Analytical Services, Radhakrishna Tirumalai, PhD, USP, Edward Tidswell, PhD, Merck, and Donald Singer, GSK

Strategies to Address E/L Container Closure Challenges

Rebecca Stauffer, PDA

Industry Converges on Pharmacopeial Convergence

Rebecca Stauffer, PDA

India Chapter Goes into the Cold

Biny Joseph, PDA India Chapter Coordinator

Visual Inspection Workshop Addresses Annex 1, New Tech

John Shabushnig, PhD, Insight Pharma Consulting; Rick Watson, Merck and Rob Miller, Pfizer

Russian GMP Inspections Present Challenges, Opportunities: Part II

Vladislav Shestakov, Russian State Institute of Drugs and Good Practices, and Elizabeth Meyers, Amgen

Russian GMP Inspections Present Challenges, Opportunities: Part I

Vladislav Shestakov, Russian State Institute of Drugs and Good Practices, and Elizabeth Meyers, Amgen

Not So Different After All

Rebecca Stauffer, PDA

Reclaiming Efficiency Amid Serialization Nightmares

Vito Pirrera and John Jordon, Vantage Solutions

Evaluating Cell Viability After Cryopreservation

Brian J. Hawkins, Alireza Abazari, Aby J. Mathew, BioLife Solutions

PDA Participates in Nipro Experience Days

Janie (Jahanvi) Miller, PDA

New Serialization Regs Impact Global Pharma

Darryl Peterson, Antares Vision

2018 PDA Summer Reading

Rebecca Stauffer, PDA

A Risk-Based Approach to Supplier Management

Rebecca Stauffer and Aneeta Mathur-Ashton, PDA

Viscous Product No Match for New CCI Tech

Oliver Stauffer, PTI

Blockchain: Will it Transform the Pharmaceutical Supply Chain?

Mark Crawford

A Not-So-Sweet Smell: Part II

Anthony Newcombe, PhD, and Siegfried Schmitt, PhD, PAREXEL

Are You Ready for the eCTD Mandate?

Mckenzie Orchowski, Biologics Consulting

Quality/Compliance Management for Virtual Companies

David Chesney, DL Chesney Consulting

Five Critical Endotoxin Testing Concerns

Jennifer Farrington, PhD, Associates of Cape Cod, and Friedrich von Wintzingerode, PhD, Roche Diagnostics GmbH

Opportunities to Build and Grow Your Network

Rebecca Stauffer, PDA

Visual Inspection Remains Critical

John Shabushnig, PhD, Insight Pharma Consulting, and Markus Lankers, PhD

How to Best Tackle Biosimilar Challenges

Stephan Krause, PhD, AstraZeneca Biologics, and Jens Schletter, PhD, Novartis

3 Questions for Biogen’s Amy Wilson

Rebecca Stauffer, PDA

Pharma Must Work “Smarter” in New Era

Toni Manzano, bigfinite

Chapter Grows Professional Opportunities Across Industry

Elizabeth Hunt, Pharmalex, Ireland Chapter Event and Media Administrator

Prospects for Post-Approval Change Management

Naheed Sayeed-Desta, Apotex, Ajay Babu Pazhayattil, and Ivy Louis, Vienni Training and Consulting LLP

Eyeing the Future of Biomanufacturing

Victoria Hayes, ICQ

A Not-So-Sweet Smell: Part I

Siegfried Schmitt, PhD, and Anthony Newcombe, PhD, PAREXEL Consulting

Can ICH Q12 Unlock Manufacturing Innovation?

Ursula Busse, PhD, Novartis, and Melissa Seymour, Biogen