Articles in this Issue

• Global Biomanufacturing Trends, Capacity, and Technology Drivers: Industry Biomanufacturing...

  Patti Seymour, Dawn M. Ecker
  As the number of commercial products and pipeline candidates grows, a crucial issue facing the industry is the current and future state of biomanufacturing capacity.

• Exposure Based Limits for Controlling Impurities

  D.P. Elder
  The use of medicinal products is always a compromise between acceptable risks and likely benefits, the same is not true for impurities.

• Controlled Release Roundtable

  The latest technologies in controlled release are formulated not only to provide specific release characteristics, but also include one or more other functionalities.

• Optimizing the Method for Authenticating Pharmaceutical Products of Different Dosage Forms...

  Sulaf Assi, Louise Fortunato
  Handheld Raman spectroscopy has emerged over the last few years as a rapid technique for authenticating medicines.

• An Interview With... Tom Blanton, Executive Director, International Centre for Diffraction...

  A number of approaches have been developed to improve the solubility of an API including particle size control and chemical modifications.

• Pirkle-Type Chiral Stationary Phases for Ultra-High Performance Ultra-Fast Enantioseparations

  Martina Catani, Omar H. Ismail, Simona Felletti, Francesco Gasparrini, Luisa Pasti, Valentina Costa, Alberto Cavazzini
  During the last decade, column manufacturers have put much effort into the design and preparation of materials suitable for highly efficient and fast separations in UHPLC.

• An Interview With... Tom Tague, PhD, Applications Manager, FTIR/Raman Products, Bruker Corporation

  Bruker provides a full suite of analysis capabilities from simple manipulations to the intricate evaluations.

• FDA’s Regulatory Science Program for Generic PLA/PLGA-Based Drug Products

  Yan Wang, Wen Qu, Stephanie H. Choi
  Polylactide (PLA)/Poly(lactide-co-glycolide) (PLGA) is widely used in many FDA-approved drug products.

• Non-Uniform Sampling for All: More NMR Spectral Quality, Less Measurement Time

  Frank Delaglio, Gregory S. Walker, Kathleen Farley, Raman Sharma, Jeff Hoch, Luke Arbogast, Robert Brinson, John P. Marino
  Nuclear Magnetic Resonance (NMR) spectroscopy is an indispensable tool in the pharmaceutical industry, with uses in drug discovery, development, and manufacturing.

• Automated and Rapid Methods to Assess Quality & Stability of Biologics: Recent Developments...

  Dr. Danny K. Chou, PharmD, PhD, Dr. Mitra Mosharraf, PharmD, PhD, Dr. Rajiv Nayar, PhD, Dr. Michael F. Drenski, PhD
  Therapeutic proteins are challenging to develop and manufacture because their marginal stability makes them prone to denaturation and aggregation during purification, storage, distribution, and administration.

• The Microbiome Effect: Link Found Between Immunotherapy Success and Gut Flora

  Emilie Branch
  Recent data has shed light on the link between the human microbiome and the effectiveness of immunotherapeutics.

• Pharmaceutical P.I.N. Points Patent Innovation News

  Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
  The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in February-March, 2017.