Articles in this Issue

• Lessons Learned from the First GDP Inspections in the Netherlands Based on the New EU GDP Guidelines

  Riekert Bruinink, Rafik H. Bishara, Ph.D.
  It has been more than one year ago that the new EU GDP Guidelines came into enforced implementation. It is an improvement and a step forward over the previous 1994 Guidance as the new one better reflects the various changes in the distribution industry which occurred during the last 20 years.

• Method Robustness Considerations for Successful Product Commercialization

  Xin Bu, John A. Castoro
  Analytical method robustness has gained significant attention in the pharmaceutical industry in recent years for many reasons, including regulatory environment change, globalization, and outsourcing trends.

• Maintaining the Relationship with a CMO

  Peter H. Calcott PhD
  Successfully navigating the setting up and use of contract manufacturing organizations (CMOs) is a daunting task, or actually, tasks. Over the years I have set up and managed these relationships successfully and now as a consultant I am often brought in when problems arise. What I find is often the planning is weak and the execution even weaker. My father used to warn me that with any endeavor “I cannot guarantee success if you plan well but I can guarantee failure if you plan weakly”. And so it is for using a CMO.

• A Framework for Managing Supply Chain Integrity and Supplier Quality

  Bikash Chatterjee, Jorge Basso
  Ensuring supply chain integrity today in the global market requires integrating risk management for a physical and a virtual supply chain. An approach that ensures supplier quality and performance and supply chain integrity is very important. The issuance of HR3204 Drug Quality and Security Act (DQSA) has set the timeline and metrics for demonstrating supply chain integrity for the next decade. To set the scene, today there are more than 70 countries that have either implemented or plan to implement some form of serialization as a key component of efforts against drug diversion or adulteration.

• Considering the Standardization of Strategies for Establishing Extractables Profiles for Plastic...

  Dennis Jenke, Ph.D.
  An accelerating trend in biotechnology is the use of plastic components in systems used to produce an active pharmaceutical ingredient (API) or a finished drug product (FDP).

• HORIZON LINES: A Quarterly Review of NDAs - 2Q14

  Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
  This column summarizes New Drug Applications (NDAs) for the third quarter 2014 (July through September 2014). In this quarter, FDA approved 38 NDAs.

• The Increasing Shift of Clinical Trials to CROs

  Lina Wang, Eduardo F. Motti, M.D.
  In the last decade, industry has changed operations of clinical research from a vertical and fixed reporting model, with a large number of in-house professionals dedicated to clinical studies, to a matrix model involving both internal and external resources, and then gradually moved the bulk of the work to Contract Research Organizations (CROs). To discuss why and how this happened is the main purpose of this article, and how it impacted the work done in the countries where the trials are conducted.

• The 5 “Secret” Factors for Getting Great Value from CMO Relationships with Pharma

  Kevan Reeve
  Excellent relationships are the key to success in life—wouldn’t you gree? So why, when I reflect on contract manufacturing organizations (CMOs) working with pharmaceutical companies, do I see a major gap in capability and focus in this all important area? I don’t actually have a definitive answer to that question, but I do have some thoughts on how CMOs and pharmaceutical companies can get great value from their relationships.

• Trends in Enhancing API Solubility

  Paul F. Skultety, PhD
  Arguably, the biggest obstacle to achieving Active Pharmaceutical Ingredient (API) success in formulation development is API solubility. Solubility — the ability of a solute to dissolve in a solvent in a homogeneous manner — is essential to realizing the desired concentration of a drug in systemic circulation for an anticipated pharmaceutical response. Yet more than 40 percent of all New Chemical Entities (NCEs) have less than ideal solubility. Fortunately, today’s formulators have a range of excellent and steadily improving echniques available to provide acceptable solubility. The key to optimizing API success is having access to the right expertise and equipment.

• CRO Outsourcing Trends For 2015: The Move to the Cloud, the Web and Mobile Technology Continues

  Nigel Walker
  According to Nice Insight’s 2015 Pharmaceutical and Biotechnology outsourcing survey, over half of the companies that outsource only to contract resource organizations (CROs) expect they will achieve reductions in project lengths and costs by using CROs that employ cloud-based systems. Nearly 50% of respondents also believe that the use of web-based life science labs will improve cost and time efficiencies. Mobile technology is also seen as enabling communications and study monitoring. In addition, 96% of survey respondents indicated an interest in working with a CRO that implements new technologies that improve efficiency, quality, safety, and traceability.