Articles in this Issue

• Evaluating Handheld Spectroscopic Techniques For Identifying Counterfeit Branded And Generic...

  Sulaf Assi
  Counterfeit medicines represent a global public health problem which accounts for 10% of the world market including 50% in some countries. Medicine counterfeiting can occur to any class of medicines, any type of formulation and can be encountered anywhere in the world. Consequently, rapid methods are needed to identify counterfeit medicines at their site of origin. Handheld spectroscopic techniques offer this advantage.

• A Perspective on the Application of Preparative Supercritical Fluid Chromatography Using Achiral...

  Mirlinda Biba, PhD, Jinchu Liu
  Preparative supercritical fluid chromatography (SFC) has been adopted as the technique of choice for the small scale preparative purification of chiral compounds and it is now widely used in the pharmaceutical industry. The benefits of preparative chiral SFC purifications, including savings in cycle time and cost have now been fully realized.

• Review of Dry Powder Inhaler Devices

  Xiang Kou, Xiaoping Cao
  The dry powder inhaler (DPI) device is paramount to the success of a DPI product. It is the vehicle the formulation is delivered through for local or systemic effect via pulmonary the route. The successful delivery of drugs into the deep lung depends on the integration between device performance and powder formulations. The combination of the device and the formulation needs to demonstrate safety, efficacy, bioequivalence and reliability for product approval.

• Antibody-Drug Conjugates: A New Paradigm for Cancer Treatment Part II

  Nilanjana Das, PhD
  Over the last couple of decades, antibody-drug conjugates (ADCs) have continued to evolve as a rapidly growing drug targeting technology for the treatment of cancer. ADCs consist of a cytotoxic drug connected by a linker to an antibody, which delivers it specifically to the target cancer cells with abundant cell surface associated antigens.

• What are the Odds? A Stochastic Approach for Predicting the Probability of Success in Conventional...

  Erin J. Ennis, Joe P. Foley
  A general goal of high-performance liquid chromatography (HPLC) is the separation of all the components of interest in increasingly complex samples while maintaining or even reducing the analysis time. While there are multiple approaches to address this goal, increasing the peak capacity has certainly become an essential strategy. While implementing that strategy, however, it is important to know the likelihood that such an approach will lead to success.

• Assessment of Techniques to Determine Bacterial Contamination in Water

  Colin Fricker, PhD FRSB FRSPH
  Water is crucial to pharmaceutical operations and the design of a water system within manufacturing facilities must minimize the opportunity for microbiological contamination. The type of water system used will depend on the process, or at which stage of manufacture the API is at, but it is paramount that the water is not detrimental to the product at any stage. There are a number of purification techniques that can be incorporated into the systems to reduce the microbial count, but as important is the regular testing regime of the water, to ensure the results are both accurate and reliable.

• An Interview With... Dr. Michael J. Miller, President, Microbiology Consultants, LLC

  A few companies have developed rapid methods for monitoring pharmaceutical grade water and are currently being evaluated by early adopters or beta test sites within the industry. The technology is based on real-time detection and enumeration of microorganisms via intrinsic fluorescence when a laser (at a specific wavelength) excites cellular components such as riboflavin and NADH.

• Ways to Lower Costs of Clinical Trials and How CROs Help

  Emilie Branch
  Over the last few years, the complexity, size, length and globalization of clinical trials have continued to grow - in parallel with soaring trial costs. We know that the estimated average cost of bringing a drug to market in the U.S. is about $2.6 billion,1 and the largest portion of drug development cost is for human clinical trials; particularly for Phase III trials, the most crucial and time-consuming phase.

• Key Criteria for the Selection of Rapid and Alternative Microbiological Methods

  Tim Sandle, PhD
  Rapid microbiological method technologies aim to provide more sensitive, accurate, precise, and reproducible test results when compared with conventional, growth-based methods. Rapid methods normally involve some form of automation and the methods often capture data electronically.

• Get Smart: The Value of Fully Integrated Sample Preparation for Chromatography/Mass Spectrometry

  Emmanuel Varesio, Sandra Jahn, Sandrine Cudré, Gérard Hopfgartner, Renzo Picenoni, Guenter Boehm
  Pharmaceutical companies are under increasing pressure to bring products from discovery through to market quickly and cost-effectively. Where this isn’t possible, ‘fail early, fail cheap’ have become industry watchwords in a sector where commercial drivers dictate that investment is focused where products can be most readily developed.

• Regulatory Considerations for the Development of Novel Antibody-Related Products

  Qing Zhou, PhD, Marjorie Shapiro, PhD
  Since the development of anti-diphtheria antitoxins in the 19th century, researchers and physicians have investigated antibodies due to their remarkable characteristics and great potential for clinical applications.

• Track and Trace

  The biggest advice we can give to be prepared is to look at the challenge holistically – and not just as a packaging problem of putting serial numbers on bottles. Much of the industry is viewing serialization as a packaging line problem, when in fact, that’s only one piece of the challenge.