Articles in this Issue

• Challenges and Benefits of Using ISTA’s Standard 20 for the Development of ISC’s

  Edward A. Church, Eric Hiser
  ISTA Standard 20 Revision 2.0 is a process standard developed by pharma industry experts. It is a design and qualification process that applies the Quality-by-Design (QbD) approach. The structure and path to design, test, verify and independently certify a specific Insulated Shipping Container (ISC) for use is provided. It sets the minimum requirements for qualifying insulated shippers and has been proven to develop shippers which meet regulatory expectations.

• Implementation and Long-Term Maintenance of QbD Products in a Virtual Supply Chain

  Ivelisse Colón, Joseph Medendorp
  Quality-by-Design (QbD) is now a well-established and commonly employed approach to the development and commercialization of products in the pharmaceutical industry. According to a 2012 survey conducted by Kourti and Davis1, eleven of the twelve pharmaceutical companies surveyed indicated they use QbD to some capacity in the development process.

• Contamination Control and Environmental Monitoring of GMP QC Cell-Based Bioassay Laboratories

  Jon Denissen, PhD, Peter Wunderli, Ph.D., Moira Elmore, PhD, Erica Golueke
  Biotherapeutic medicines generated by living cells or organisms are larger and more complex than chemically synthesized, small molecule medicines and feature varied mechanisms of action (MOA). They also are more prone to heterogeneity, and subtle differences may occur across product lots, resulting from differences in conditions used in their production processes, including variables such as differences in cellular post-translational modification, cell passage and culture, production and purification.

• The Perils and Promise of Strategic Partnering with CROs

  Jonathan Hughes, Stuart Price
  Strategic partnerships have long been a major feature of the pharmaceutical industry. In-licensing, out-licensing, joint research, and codevelopment arrangements between and among bio-pharmaceutical companies, and with academic research institutions, abound. Approximately 33% of drugs in the pipelines of the top ten pharmaceutical companies were initially developed elsewhere, according to a 2014 WSJ article by Jonathan D. Rockoff.

• CMOs Step Up in Areas Where BioPharma is Short-Staffed

  Eric S. Langer
  The biopharmaceutical manufacturing community continues to find it difficult to staff key positions, and is turning instead to outsourcing to fill the gaps. According to preliminary results from BioPlan Associates’ 13th Annual Report and Survey of Biopharmaceutical Manufacturing, hiring trends continue to plague the industry, and it is finding relief by outsourcing some increasingly core activities. Results from the report indicate that experienced process development (PD) expertise is very challenging to find. And this is leading to an increasing number of companies looking to outsource their PD activities.

• HORIZON LINES: A Quarterly Review of NDAs – 3Q15

  Sonal Pathak, MS, Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
  Twenty-five (65.8%) NDAs were for small molecules while the remaining 13 (34.2%) were for large molecules. Most of the large molecules were used in the cancer therapy. In this quarter, 18 companies (47.4%) receiving NDA approvals were large companies and the remaining 20 companies (52.6%) were mid-sized and small companies.

• Expect Pharmaceutical Contract Manufacturing to Continue Apace in 2016

  Nigel Walker
  All signs point to further healthy growth of the pharmaceutical contract manufacturing market in 2016. For the fourth year in a row, respondents to Nice Insight’s annual survey of outsourcing-facing pharmaceutical and biotechnology executives expect spending on outsourcing to increase over the next five years. Other results of the survey indicate, however, that only service providers that meet specific criteria will be considered for potential partnerships.