Articles in this Issue

• The Long Paper Trail of Documentation in API Manufacturing

  Ed Price
  Documentation – and loads of it – is essential in API manufacturing if a company wants to comply with current Good Manufacturing Practice (cGMP), and eventually seek and obtain FDA approval.

• Pharma Requirements for Temperature Controlled Trailers

  Erik J. van Asselt, PhD, Rafik H. Bishara, Ph.D., Zvonimir Majic PhD, Volker Cloos, Peter Wilms, Marco Del Giudice, Hans van Overveld, Eric Stener, Frans Sanders, Jeroen Janssens, Oumer Salim, Marco Pikkemaat
  Critical design parameters of trailer equipment and operational handling procedures in road transportation have a major impact to the airflow and temperature distribution within temperature controlled road vehicles.

• Strategies for Maximizing the Benefits of Outsourced Site Contract Negotiation

  Danielle Marie Boram
  It is worth asking, why should we even care about site contracts? Admittedly, in the clinical operations space there are many issues that seem infinitely more important and exciting than sending a document back and forth a few times and then hunting busy, important people down to sign it.

• Outsourced Service Providers - or an Ecosystem of Strategic Partners?

  Jan Twombly
  How to Build the Mindset, Skillset, and Toolset to Collaborate with Providers - and Maximize the Performance of Your Biopharma Ecosystem.

• How to Get it Done – Tips and Tricks for Successful Deal Making

  Christoph Pittius, PhD
  This paper provides practical guidance on the steps to take to successfully execute a licensing agreement.

• Non-Animal Technologies Transforming Safety Testing Markets

  Brian Burlinson
  The pharmaceutical safety assessment market is experiencing exponential growth in the use of NATs driven by a combination of regulatory, political and social factors as well as advances in science and technology.

• Packaging Roundtable

  Within the clinical trial supply arena, one of the most significant changes on the horizon is the impending rollout of the European Commission’s Clinical Trial Regulation (CTR) EU No. 536/2014 Annex VI.

• Perfusion Appears to be Gaining Traction in Biopharma Manufacturing

  Nigel Walker
  Perfusion cell culture is not a new concept. It was first introduced in the early 1980’s as a means for improving the productivity of cell-culture processes, which at the time generally suffered from low titers and inefficiencies.

• HORIZON LINES: A Quarterly Review of NDAs November 2016 – January 2017

  Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
  This column summarizes New Drug Applications (NDAs) approved in the November-December 2016 and January 2017. FDA approved 30 NDAs in these three months.