Ronald A. Rader, Eric S. Langer
Biosimilars are continuing to change the biopharmaceutical industry. Some biosimilars and biogeneric products have already entered world markets, and the rather full development pipeline1 means many more are coming, along with many new entrants into the biopharmaceutical industry. This article reviews aspects of the biosimilars’ development pipeline and some of the changes biosimilars are promoting within the biopharmaceutical industry, particularly changes in biopharmaceutical manufacturing (bioprocessing).
Angel L Salaman-Byron
Pharmaceutical companies have been engaging the use of environmental isolates (EI) for tests for media growth promotion. Currently, Regulatory Authorities expect evidence of the use of EI in growth promotion testing (GPT). Regulatory enforcement of these expectations often resulted in observations from health authorities around the world.
Stuart Levy
The form of an active pharmaceutical ingredient (API) can be defined as both the chemical and physical state in which it is isolated and supplied for the development and manufacturing of drug product. Because the nature of the API form required and selected is highly dependent on both the stage of development of the drug and the needs of the formulation being pursued, forms of a given API used for drug product development and manufacturing are variable.
Christine P. Chan
Criticality assessment of product quality attributes forms the foundation of the Quality by Design (QbD) approach to drug development. This systematic approach to product development emphasizes product knowledge and process understanding along with process control based on sound science and quality risk management. Due to complexity of the molecular structure as well as the manufacturing process, development of biotherapeutics remains challenging. It is often difficult to fully evaluate the impact of the large number of quality attributes as related to safety and efficacy.
Tim Sandle, PhD
Data integrity relates to any type of ‘data’, and the degree to which a collection of data is complete, consistent, and accurate. Data can exist in a variety of forms – as numbers or text on paper or as bits and bytes in electronic form. No single type of data is exempt from data integrity concerns, and such concerns have been part of a growing focus from regulators across pharmaceuticals and healthcare.
Sven Stegemann
As life expectancy continues to increase around the world, healthy aging is increasingly an area of research focus for the pharmaceutical industry. Aging in good health and adding years that are free of disease and disability to one’s lifetime are important both for individuals and for society as a whole. As a result, repurposing drugs to delay aging and age-related disease is increasingly becoming a source of medical innovation.
With outsourcing as a core component of most drug development programs, deeper understanding of the risks and advantages presented by Single Use Disposables (SUDs) has catalyzed their adoption.
Rodolfo J. Romañach, PhD
Academic research groups celebrate the departure of students that move to industry or other research groups. The success of the research group depends on managing student turnover as graduates move on to positively impact other laboratories. Turnover, is essential at the academic level, contrary to industry where the departure of an experienced scientist is a significant loss and where personnel changes can jeopardize operations. However, at academic, government, and industrial labs there is a need to create expertise in near infrared (NIR) spectroscopy and chemometrics, which are important elements of Process Analytical Technology (PAT).
Anvit Vasavada, M.S, Sunny Christian, MS, Hemant N. Joshi, Ph.D., MBA, Neelam Sharma, M.S.
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in January 2019.
Xiaoyang Zheng, Scott Sacra, Marc F. Verhagen, Claire Davies
Expedited development of biopharmaceuticals requires a focused, consistent and efficient analytical development strategy. For commonly monitored critical quality attributes, robust platform methods can be implemented and used for a defined class of molecules thus minimizing the need for additional development. For new compounds, or when new attributes need to be monitored, additional method development will be required but this process can be accelerated by adopting a focused approach consisting of four stages with well-defined deliverables (method definition, technology selection, method development/optimization, and method performance evaluation).
A. Kielt, I. Nir, J. Seely, G. Inman
UV Spectrophotometry has traditionally been a simpler and less time and labor consuming method for analyzing dissolution testing samples. However, as soon as a product contained more than one active pharmaceutical ingredient (API), analysis with UV was no longer considered an option. This is because both species often absorb over the same spectral region, causing deviations from Beer-Lambert Law.
Jane Li, PhD, Stefanie Gee, Larry Wigman, Ph.D., Jeffrey Davis, Wei Zhang
This paper describes a Transmission Raman Spectroscopy (TRS) method for the content uniformity analysis of a solid oral dosage form of an early phase development compound. A partial least squares (PLS) model was built to quantitate the API content in tablets. The model used six latent variables and, using a venetian blinds cross validation, showed comparable root mean square errors for calibration and cross validation (RMSEC = 0.31, RMSECV = 0.42). The tablets analyzed were from a formulation design of experiment (DOE) study exploring excipient content, API content, and granule solid fraction. The linearity of expected versus measured results showed good correlation between the two (r2 = 0.997). This method was compared to an HPLC method for both accuracy and precision. TRS results generally agreed well with HPLC results, especially when matrix effect was not an issue. Both methods had comparable precision. TRS method was affected by compaction force during dry granulation and was shown to produce consistently higher results with higher compaction forces due to matrix effect.