Articles in this Issue
Tim Sandle, PhD
The majority of contamination in a pharmaceutical facility, presuming that the air handling system is functioning as designed, that water systems are low in bioburden and are not leaking, and there is good control of in-coming materials, will derive from people. It follows that an effective contamination control strategy will focus on the control of operators. Control extends to behaviors, gowning and having the correct equipment, and this will be supported by periodic qualifications and underpinned by audits.
Phillip Gerk, PharmD, PhD
In regards to oral bioavailability, much research and discussion have been levied against two issues: solubility and permeability. Depending on the drug molecule, its dose, and its application, release from the oral dosage form, dissolution into gastrointestinal fluids, and avoidance of precipitation may each require significant formulation efforts and strategies.
Ilene Roizman
Single-use bioprocessing equipment has made considerable progress in the past 10 years. An estimated 10% of current total worldwide bioprocessing capacity, or about 1.7 million liters, involves primarily single-use system (SUS) process lines. The market has grown from a few legacy products, such as plastic serum and media storage bags, tubing, and filter membranes, to the current situation where single-use technologies represent the majority of non-commercial applications in bioprocessing. This includes a wide variety of products and novel technologies currently available and in development.
Jeanne Moldenhauer
If you have been in the pharmaceutical industry for any length of time, you have probably been exposed to some concern in your facility regarding fungi, i.e., yeasts and molds. The New England Compounding Center (NECC), of Framingham, MA had a fungal contamination that led to a significant outbreak of meningitis in 2012. Sixty-four deaths and numerous non-fatal injuries occurred as a result of this contamination. This outbreak changed regulatory controls for compounding pharmacies and a heightened regulatory concern about fungal contamination in manufacturing facilities. (Anonymous, 2019)
Manfred Maeder, PhD
Within the pharmaceutical industry the share of combination products has increased significantly during recent years. This is linked especially to the rise of biologics products. For the US, during fiscal year 2017, for the first time FDA received more biologic applications compared to small molecule applications.
Daniel R. Willett, Huzeyfe Yilmaz, Anna M. Wokovich, Jason D. Rodriguez
Confocal Raman mapping provides a robust means of characterization that can non-destructively provide both chemical and structural information for a wide range of pharmaceutical dosage forms.1-3 A literature review of Raman mapping for pharmaceuticals shows the spectral ranges used in studies is primarily limited to Stokes signals that are 200 to 4000 cm-1 away from the excitation laser line. This region is accessible with most commercial instruments and allows extracting valuable fingerprint information about molecules such as aromatics, carbonates, sulphates, silicates, oxides and hydroxides within the 500-1500 cm-1 range, and hydrogen interactions with carbon, nitrogen and oxygen at around 3000 cm-1.
The contribution of functional excipients has greatly increased over the last decade. The key impacts made by functional excipients in finished products include solubility and range in some cases from drug efficacy to masking taste and extending product shelf life.
The usual suspects are aging facilities, the incomplete implementation of barrier technologies, sterile products being aseptically filled when they are candidates for bioburden-based terminal sterilization, poor product failure investigations and corrective actions, and the general lack of manufacturing excellence.
Suhaila O. Suliman, Emad I. Wafa, Sean M. Geary, Aliasger K. Salem
Vaccines have been successful at preventing a range of diseases including diphtheria, polio, whooping cough, measles and tetanus; whereby incidences of such diseases are now rare in developed countries. In fact, thanks to vaccines, smallpox has been successfully eradicated worldwide whilst polio is on the verge of global eradication.
Anvit Vasavada, M.S, Sunny Christian, MS, Neelam Sharma, M.S., 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 2019.