Reyes Candau-Chacon, Ph.D., Patricia Hughes, Ph.D
Pharmaceutical product container closure systems (CCS) should be designed to ensure that a drug product (1) is protected from factors that may impact product quality over its shelf life, including light, evaporation, exposure to gases, absorption of water, or microbial contamination; (2) is compatible with the selected CCS and that there is a lack of product—CCS interactions that might lead to a loss of potency due to absorption, degradation, or precipitation; and (3) that CCS manufacturing materials are safe for use with the dosage form and the route of administration. In addition, if the CCS has a performance feature, the assembled CCS should be demonstrated to function properly.
Product characterization is the essential foundation for successful biological drug development.
Electrospinning is rapidly emerging as a new pharmaceutical processing technology with great potential in medicines development. In the most common experimental set-up, a solution of a polymer and functional component (in this context an active pharmaceutical ingredient (API) is prepared in a volatile solvent. This is then loaded into a syringe fitted with a metal needle (the spinneret). A pump is used to extrude the solution through the needle at a controlled rate.
Stuart Levy
Integrated chemistry, manufacturing and controls (CMC) development views the entire effort to develop and supply a drug’s dosage form holistically. While there are certainly distinctions between the activities contributing to pharmaceutical development and drug supply, an integrated approach looks for overlap, synergies and dependencies between activities. This approach proceeds with an awareness of the interdependency of component activities, as well as cognizance of activities outside of the realm of CMC that impact and are impacted by CMC strategy. A drug candidate’s molecular properties determine options for preclinical and clinical dosing. However, preclinical and clinical data, once obtained, also drive changes in a drug’s formulation, which can necessitate an adjustment of the physical form of the active pharmaceutical ingredient (API).
Hibreniguss Terefe, PhD, Isaac Ghebre-Sellassie
Part I provided an overview of the historical perspective of the genesis and application of spray drying and melt extrusion as robust and efficient manufacturing processes. In this section, an attempt will be made to compare and contrast spray drying and melt extrusion amorphous solid dispersion manufacturing processes by focusing on three key components – feed material preparation, processing conditions and product characteristics.
K. John Morrow, Jr., Eric S. Langer
In recent years, the application of single-use technologies in the bioprocessing industry has become more widely adopted, even while a longstanding demand for stainless steel, reusable devices in large scale production continues mostly unabated. This growth, documented in our 16th Annual Report of BioManufacturing1, shows that over the past 13 years single-use bioreactors, and mixing systems, grew by 59 percentage points, 55 points, respectively.
Josephine Taniguchi, Hekla Alite, Cynthia A. Heinlein, Keri E. Cannon, Steven Bloom, Larry Wigman
Nitrosamines are a well-known group of highly potent, mutagenic impurities formed by the reaction of secondary amines with nitrite under acidic conditions. Nitrosamines have been studied for many years due to their presence in foods, cosmetics, tobacco products, industrial solvents, and alcoholic beverages. Nitrosamines are described in the International Conference for Harmonisation (ICH) M7(R1) Guideline5 as Class 1 impurities which are high-potency, mutagenic carcinogens. In addition, nitrosamines are part of the infamous “cohort of concern” along with aflatoxin-like structures and alkyl-azoxy compounds.
Didier Combis, Christine Adam, Jean François Cordoliani
Since the Pediatrics Regulation enforcement in Europe in 2007, and in 2003 in the U.S., it is now compulsory for the pharma industry to develop pediatric dosage forms for each and every new entity, as it does for adults.
María A. Fontalvo-Lascano, Mayra I. Méndez-Piñero, Ph.D., Rodolfo J. Romañach, PhD
The presentation of a new Process Analytical Technology (PAT) application to a pharmaceutical company is often followed by the question: “But what is the business case?”, or request: “A stronger business case is needed”, or “The business case has to be clear”. The pharmaceutical scientist is often unprepared for this question and is only prepared to explain scientific/technological issues: the design of experiments proposed for process understanding and how a PAT method works. The scientist has studied the process thoroughly and is ready to explain the critical process parameter that is being monitored, the frequency with which measurements would be obtained, and possible control options. As the PAT methods are not easy to explain or understand, the scientist is often completely focused on the scientific aspects, and not the business case. The implementation of PAT will require a Capital Investment Project because it is often a large scale, long-term project and represents a large investment in time, personnel and overall resources, hence the importance of a well-structured business case. The approval of the capital project may take a year or more depending on the company and the complexity of the project. However, very few articles have addressed the importance of developing a strong business case to advance PAT implementation in industry.
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 November-December, 2019.