Michael Auerbach
Is anyone old enough to remember a time BEFORE email was the ubiquitous communication tool it is today?
Antonio Costa, PhD
As succinctly stated by former FDA commissioner, Dr. Scott Gottlieb, and CDER Director, Dr. Janet Woodcock, “One of today’s most important tools for modernizing the pharmaceutical industry is a process known as continuous manufacturing…”. A critical challenge in the pharmaceutical industry is the balance between quality and throughput – the solution, continuous manufacturing. Over the past 10 years, notable advances in manufacturing have led to continuous manufacturing systems with a major emphasis on tablet production and API synthesis.
Roberto Pisano, Ph.D.
This paper deals with the problem of continuous lyophilization of pharmaceutical products, focusing on those concepts that are of greatest interest and most likely to be successful once applied in industrial practice.
Monographs and general chapters that provide public quality standards for drugs, excipients, and dietary supplements are published in the United States Pharmacopeia and the National Formulary (USP–NF).
Dr. Johannes Kiefer
Pharmaceutical products usually comprise of active ingredients and a number of excipients. The amount of the actual drug can be very small and hence there is a need for highly sensitive and specific techniques for quantitative and qualitative analysis. Surface-enhanced Raman spectroscopy (SERS) is introduced as a particularly promising tool in this context. For example, it can be employed for analyzing pharmaceutical products, but it can also help to better understand the interactions between pharmaceutically active compounds with pathogenic germs and biological organisms and, thereby, it may contribute to the development of target-specific treatments, e.g. for the currently spreading corona virus disease, COVID-19.
Drug development in general is in a strong phase, with FDA approval numbers also being very healthy. Looking at inhaled drugs specifically, the sector is showing encouraging numbers, with over 300 molecules in development that require an inhaled route of administration.
Monitoring and controlling contamination is a huge piece in any pharmaceutical companies’ SOPs. An issue we all have, including pharmaceutical companies, is time.
As the pharmaceutical industry slowly moves away from its very conservative approach to manufacturing and starts to embrace more efficient and flexible technologies to bring products to market faster and with increased quality, the use of prefabricated cleanroom suites has emerged as a very effective way to quickly get facilities, from lab to production environments, up and running.
Brittany Handzo, Anna Luczak, PhD, Scott Huffman, Jeremy Peters, Ravi Kalyanaraman, Ph.D.
Throughout the last few years, there has been a growing trend in counterfeit cases involving pharmaceutical products.
Process understanding is essential to achieving high-yielding, robust, and reliable pharmaceutical manufacturing processes. Albemarle applies a combination of technical expertise, creativity, collaboration, and a culture of continuous improvement to solve difficult process development challenges.
Randy Hutt, PhD, Donald J. English, Editing by Samia Ahmad, Ph.D.
To start with the end in mind, the current USP Chapter <1111>1 “Microbiological Examination of Non-sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use” has recommended microbial limits for aqueous non-sterile products of less than 100 Colony-Forming Units (CFU)/milliliter (mL) of bacteria, less than 10 CFU/mL of fungi and the absence of Escherichia coli in 1 gram (g) or mL.
I have not seen a major change in the actual market drivers for single-use or disposable technologies.
Lynn Johnson, Christoph Hansy
The necessity – from a patient and business perspective – along with increased pressure from regulators to establish contamination control programs at pharmaceutical manufacturing facilities, have led to a need to define what elements would comprise such a program and how the program would be sustained to ensure continued success. Contamination control encompasses all aspects of contamination such as particulate, microbial, product carryover, chemical (e.g., cleaning material residue), as well as viral, where applicable. This article aims to outline the strategy from global development through site implementation, within the lens of lifecycle management to ensure continuous improvement. Local strategies can easily be derived from this approach.
Nick Thomson
The pharmaceutical industry has utilized batch capability as the primary means of manufacturing small molecule active pharmaceutical ingredients (API) for decades.
Amanda Bishop McFarland
If you were tasked with assessing your Quality Risk Management (QRM) program, would you find yourself in the “just right” category? Characterizing the maturity of a QRM program includes the assessment of multiple parameters including the people, risk culture, QRM initiation, risk assessment, risk control, risk review, risk communication, infrastructure, and governance.
Dhanuka P. Wasalathanthria, PhD, Julia Ding, PhD, Zheng Jian Li, PhD
Real time monitoring of biopharmaceutical process development has evolved significantly in recent years with the advancement of analytical technologies, cyber-physical systems and advanced-data interrogation tools.
Jinxin Gao, Eric Adamec
Multivariate time-course data generated from cell culture processes are difficult to analyze because of multicollinearity, multidimensionality, missing data and measurement uncertainty. In this study, orthogonal partial least squares regression (OPLS) analysis is used to analyze data from 21 Chinese Hamster Ovary (CHO) cell culture bioreactor batches. The parameters include temperature, pH, dissolved oxygen, viable cell density, viability, glucose, lactate etc. This multivariate method can provide insight for bioprocess development and manufacturing. It has applications in process scale-up, real-time process monitoring, process control and fault diagnosis.
Bryant Yan
The monoclonal antibodies (mAbs) market has changed rapidly in the past five years, with mAbs representing more than 50% of the overall biotherapeutic market. Now, speed to clinic is a huge determinant of success, much of the mAb industry has migrated to platform approaches for discovery, product and process development, and mAbs therapeutics have demonstrated themselves to be particularly well suited toward the application of platform approaches. The platform providers help to optimize the product and process development that keeps improving the production yield and efficiency, and also streamlines the regulatory and quality records that allow industry and regulators alike to move faster and with greater consistency. As of December 2019, 79 therapeutic mAbs have been approved by the FDA, and approximately 25 mAbs are under review by FDA and EMA; among them, ~60% of these mAbs belong to IgG1 class.
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 2020.