This issue looks at the role of biosimilar products in the industry. John Geigert’s cover story explores the critical foundation CMC plays in biosimilar development. Michael VanDerWerf discusses post-approval change challenges for biosimilars. And Stephan Krause and the U.S. FDA’s Emanuela Lacana summarize the 2016 PDA Biosimilars Conference.

Ultrapure water expert Mike Henley looks at the overall state of water systems in pharma with an eye toward new regulations and compendial chapters. A GMP inspector discusses how the Annex 16 revision will impact the role of Qualified Persons in Europe. Novo Nordisk’s Mads Reedtz Espersen offers a new method for handling glass breakage. Plus, photos from a recent onsite meeting of PDA’s Post-Approval Change: Innovation for Availability of Medicines technical report team.

Next generation manufacturing is here! In our cover story, Annual Meeting speakers Maik Jornitz, Barry Starkman, and Mike Vandiver look at what it means for biopharma manufacturing. Amgen’s Director of Quality Colleen Walson-Billin discusses the company’s innovative mySOP initiative to introduce videos to SOPs. And this issue’s infographic provides an inside look at Industry 4.0.

In this issue, Shire’s Thomas Kreil explores how to prevent viral contamination of advanced therapy medicinal products (ATMPs) using the “Safety Tripod.” Team Consulting’s Andy Fry offers his perspective on how to successfully commercialize an ATMP. And the infographic shows the GMP process for an autologous cell therapy.

Stefan Kleinmann and Matthias Scheu of METALL + PLASTIC explore how biologics manufacturer reduced H202 concentrations in their isolator by using catalytic panels. Egmont Semmler of Groninger looks at the use of gas plasma for decontamination in aseptic processing. Plus, read some articles highlighting sessions at the upcoming 2^nd PDA Europe Annual Meeting in June.

This issue of the PDA Letter offers insights into parenteral manufacturing. Wendy Saffell-Clemmer from Baxter explores compatibility issues with prefilled syringe components. Nrupa Patel from Teligent Pharma and Sandip Patel from Navinta show how to use a QbD approach to component selection. And the infographic offers a sampling of glass defects drawn from PDA Technical Report No. 43 (Revised 2013).

Quality metrics remain a hot topic for our industry. Stephanie Gaulding summarizes PDA’s February 2017 meeting on the topic. Rebecca Stauffer covers in-depth the quality culture session from Day 2 of that meeting. And Susan Schniepp is interviewed for her thoughts on metrics. Also, content supporting the 2017 PDA/FDA Joint Regulatory Conference can be found throughout the issue.

What happens when endotoxin testing is automated? Pfizer’s Scott Kaszuba describes what happened when the company automated endotoxin testing at one of its QC micro labs. Plus, check out articles in support of the 12^th Annual PDA Global Conference on Pharmaceutical Microbiology. And check out photos from this year’s 2^nd PDA Europe Annual Meeting.

Why are prefilled syringes bringing flexibility to manufacturing? Martin Bultmann, a Universe of Pre-filled Syringes and Injection Devices speaker, offers his analysis of flexibility and automation in prefilled syringes. Plus, check out other content in support of the upcoming Universe of Pre-filled Syringes and Injection Devices conference and exhibition.

Many industries are changing their training and development strategies due to the emergence of Millennials. And pharma is no exception. Find out how parenteral manufacturers are addressing the unique needs of this generation of workers. Plus, check out photos from this year’s PDA/FDA Joint Regulatory Conference.