Articles in this Issue

• Good Things Come in Small Packages: Hand-Held Raman Instruments Come of Age

  Emil W. Ciurczak, Ph.D.
  While the Raman effect has been in college curricula for decades, for much of that time, it has been considered a research tool. The early (c. 1970) models were driven by quite powerful LASERs and had a nasty habit of burning samples (and eyeballs, if proper protection was not used).

• Microbiological Attributes of Powdered Cannabis

  Tony Cundell, Ph.D.
  Although marijuana is classified as a Schedule I drug “having no medical use, with a high potential for abuse” by the U.S. Federal Drug Enforcement Administration, Western States including Colorado, Alaska, Oregon and Washington have legalized the sale of powdered cannabis for both recreational and medical use.

• Monoclonal Antibody Targets and Indications

  Alfred R. Doig, Dawn M. Ecker, Thomas C. Ransohoff
  The past thirty years have witnessed an impressive growth in sales of therapeutic monoclonal antibody (MAb) products. This growth of MAbs as a class of therapeutics was made possible in part by the development of large-scale mammalian cell culture, which enabled manufacturing of sufficient quantities of product to meet the market demands.

• CAPA Implementation: The Human Effect

  Stuart Halasz
  The implementation of CAPAs (Corrective and Preventive Actions) in Phase 3 clinical trials presents some considerations less common in the better-controlled areas of pharma.

• Conducting Microbial Investigations

  Jeanne Moldenhauer
  Many methods and tools used in the modern pharmaceutical microbiology laboratory were derived in the nineteenth century. The methods may not seem to be complicated, but are effective and still used. For example, tools such as agar-based media, petri dishes, glass pipettes, streaking methods, Bunsen burners, and microscopes are still in use and perform well.

• Continuous Manufacturing, Near Infrared Spectroscopy and Process Knowledge

  Manel Alcalà Bernardez, Lizbeth Martinez, Ramón M Esquerdo, Doug Hausner, Rodolfo J. Romañach, PhD
  Continuous manufacturing was one of the topics discussed at the XXXV Symposium of Spain Industrial Pharmacists Association (AEFI - Asociación Española de Farmacéuticos de la Industria) in Barcelona. The leitmotif of the conference was New Horizons, Commitment to Health in Barcelona.

• The Road to the Biological IND – From Discovery to Product Production

  Michiel E. Ultee, PhD
  Numerous elements are needed to bring a promising therapeutic protein from research through development, analysis, manufacturing, and quality control (QC) and assurance (QA) for a successful IND application.

• Application of QbD Principles to the Scale-Up of a Nasal Suspension Drug Product

  Felix Francis, Wan Jiang, PhD, Pradeep Sanghvi, PhD
  Quality by Design (QbD) is a systemic approach to pharmaceutical development. It is essentially the information gathered through various stages of designing and developing formulations and manufacturing to provide scientific understanding and to support the design spaces for specification and manufacturing controls.

• Single-Use Systems Not Helping Downstream Bioprocessing, Yet… Alternatives to Chromatography...

  Eric S. Langer
  After years of slow transition, biomanufacturers are finally ranking disposable bioprocessing as their top factor creating improvements in their biomanufacturing performance, according to BioPlan Associates’ latest study, 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

• A Fresh Look at USP <1223> Validation of Alternative Microbiological Methods and How the Revised...

  Michael J. Miller, Ph.D.
  The validation and implementation of rapid and alternative microbiological methods has gained significant momentum over the past decade, with multinational firms validating new technologies for a wide range of applications including finished product release testing (e.g., sterility), environmental monitoring, in-process control, WFI analysis and microbial identification.

• Environmental Monitoring Benefits from Technological Innovation

  Guy Tiene, MA
  Environmental monitoring during pharmaceutical and biopharmaceutical production is crucial for ensuring the safety of formulated drug products. While requirements for the control of both viable (living microorganisms) and non-viable particles (e.g. dust, hair, etc.) and other contaminants (i.e. trace metals, volatiles, etc.) for aseptic manufacturing operations are more extensive than those for non-sterile processes, the quantity of samples that must be analyzed and the amount of data generated can be daunting regardless of the final drug form, particularly for global companies with multiple production facilities.

• Hydrophobic Interaction Chromatography for Antibody Drug Conjugate Drug Distribution Analysis

  Tao Chen, Kelly Zhang, Ph.D.,, Jason Gruenhagen, Colin D. Medley
  Hydrophobic interaction chromatography (HIC) is an analytical technique that utilizes the hydrophobic properties of molecules to achieve their separation. In this type of chromatography, sample molecules with hydrophobic portion(s) interact with and bind to the hydrophobic groups (e.g., phenyl groups) attached to the column stationary phase.