Articles in this Issue

• Practical Considerations on PAT Analyzer Selection - Raman vs. NIR Spectroscopy

  Saly Romero-Torres, Ph.D., Jun Huang, Ph.D., Pedro E. Hernandez-Abad, Ph.D.
  Process Analytical Technology (PAT) has been defined as a framework which allows the development of a comprehensive understanding of pharmaceutical manufacturing processes [1].

• The BET as a Backdrop for Establishing PAT and RMM Goals

  Kevin L. Williams
  FDA has defined Process Analytical Technology (PAT) as “Systems for analysis and control of manufacturing processes based on timely measurements during processing, of critical quality parameters and performance attributes of raw and in-process materials and processes to assure acceptable end product quality at the completion of the process” [1]. The concept of PAT aims at better understanding manufacturing processes, monitoring quality parameters continuously and in a timely manner (preferably in-line or on-line) and thus becoming more efficient in achieving quality assurance while reducing process variability, minimizing deleterious events, and relying less on end-product testing as an absolute arbiter of product quality.

• New Developments in Scale-Up and QbD to Ensure Control Over Product Quality

  Martin Bohlin, Ph.D., Helen Jones, Ph.D., Simon Black, Ph.D.
  The concept of Quality by Design (QbD) is described in the ICH guideline Q8 (R1) [1]. The guideline, which is written for the development of the drug product, includes the following definition of QbD: a systematic approach to development that includes incorporation of prior knowledge, results of studies using design of experiments, use of quality risk management and use of knowledge risk management throughout the life cycle of the drug product.

• Quality-by-Design as Applied to the Development and Manufacturing of a Lyophilized Protein...

  Feroz Jameel, Ph.D., Mansoor Khan, Ph.D.
  Biopharmaceuticals are complicated products to make because of their unique sensitive structures that are normally difficult to define in molecular terms. It is difficult to achieve consistency in their composition often resulting in challenges to assure product quality, and therefore to ensure safety and efficacy [1, 2].

• A Systematic Approach to Convert Ultra-Fast HPLC Conditions to Conventional HPLC Conditions

  Xiaowei Sun, Loren Wrisley
  Ultra-fast HPLC provides faster analysis time and higher efficiency compared to conventional HPLC. However, a method that is truly optimized for ultra-fast HPLC cannot be run directly on a conventional HPLC system, mainly due to pressure limitations.

• Biophysical Approaches to the Detection and Characterization of Particles in an Antibody Solution

  Charlene Brisbane, Doug Nesta, Ph.D., Amol Ketkar, Sorina Morar-Mitrica, Ph.D.
  Monoclonal antibodies (mAbs) can express their inherent physical instability by following one of several degradation pathways: adsorption, denaturation, or aggregation [1,2].

• Functionality and Performance of Excipients in Quality-by-Design World Part VI: Excipient Composition

  Dr. Chris Moreton, Ph.D.
  How much do you know about the composition of the excipients you are using? How much does anyone know about the composition of the excipients they work with? If we do not know about the composition of our excipients, can we efficiently design and develop robust formulations with an adequate design space?

• Developing an Appropriate Salt Form for an Active Pharmaceutical Ingredient

  Harry G. Brittain, Ph.D.
  Modern pharmaceutical development continues to move away from the trial-and-error method favored by Thomas Edison, and is moving toward a more computationally assisted approach that serves to minimize unnecessary experimental work.

• Pharmaceutical Counterfeiting: Unique Challenges for the Analytical Laboratory

  Scott Huffman, Lydia Breckenridge
  The increased counterfeiting of pharmaceutical products in recent years has grown into a global healthcare crisis affecting patients the world over.