Articles in this Issue

• What’s Driving Freight Costs Higher?

  C. Ray Goff, Jr.
  If you think the price of fuel is the only element driving freight costs higher – think again! The latest, “Master of Logistics 20th Annual Study of Transportation and Trends Study” [1] reports that in 2011 the highest percent of transportation costs was ground freight at 76.1%, of which US long haul trucking holds a major position at 64.4%.

• CMO Adoption of New Process Technologies

  William Downey, MBA, Helen Nicely, Ph.D.
  The market demands for higher productivity and lower costs have led biopharmaceutical contract manufacturers (CMOs) to investigate and adopt new, sometimes disruptive, process technologies. CMOs continue to invest in upstream and downstream process technologies to meet these demands. Adoption of new process technologies, such as higher titer expression systems, single-use bioreactors, and downstream purification technologies are seen as potential disruptive technologies.

• Virtual and Small Biotech Roundtable

  Thomas Fritz, Eric Hayashi, MBA
  Small/virtual companies are good partners for Swiftwater Group because their operating strategies mesh well with our services. These tightly managed companies rely heavily on outsourcing and the best companies understand the value of working with a single company that can provide integrated services. In doing so, they avoid three main traps that larger companies fall into when managing disparate vendors.

• The Effect of Formulation Excipients on Leachables for IV-Administered Products

  Jason K. Cheung, Ph.D., Manoj Sharma, Ph.D., Anita Dabbara, Jonathan Petersen
  The delivery of parenteral therapeutics through an intravenous (IV) route often involves contact with different materials associated with IV-administration devices. "In-use" stability studies are designed to ensure no loss of product quality during storage and administration. However, excipients, which are used to stabilize the drug product formulation, may also facilitate the solubilization of leachables from material contact.

• Offshoring of Chemical & Pharmaceutical R&D to Asia

  Dr. Frank U. Floether
  The pharmaceutical industry enjoyed a long period of superior financial performance. That period seems to be over. Current Big Pharma challenges can be summarized as follows:

• Interview with SCYNEXIS: Integrated Pharmaceutical Solutions Tackles Impurity Identification

  Clare Murray, Ph.D.
  SCYNEXIS has integrated offerings of high-end chemistry and biology services with a focus on Integrated Pharmaceutical Solutions, Discovery Research and Integrated Parasitology. The SCYNEXIS Integrated Pharmaceutical Solutions division offers innovative chemistry and analytical expertise that we bring to bear on our customer problems.

• Interview with EMD Millipore: 4 Questions to Ask Your Discovery and Development Services Provider

  Christina Shasserre
  Achieving precision medicine requires the integration of clinical and molecular data in the drug development process. Precision medicine is partnered with personalized medicine, or the subsequent measurement of numerous pieces of genetic, epigenomic, environmental data in order to develop a molecular signature of the patient.

• An Interview with Althea

  Kristin DeFife, Ph.D.
  With numerous biopharmaceutical patents set to expire and a biosimilars approval pathway secured in the US, the single largest trend with respect to biologics manufacturing is the growing interest in biosimilars development. Because biosimilars do not have the same drastic cost-cutting potential as traditional generics, this trend towards biosimilars is also driving interest in the development of efficient manufacturing and next-generation technologies.