Mike Auerbach
Way back in 2009, before this pandemic, before murder hornets, before everything else 2020 has thrown at us – Apple introduced its iPhone 3G.
Tony Cundell, Ph.D.
A major challenge with emerging heterogeneous, live culture-based products is setting consistent, risk-based microbial specifications to protect the recipients of these product from potential microbial infection. A review of the literature and the published regulatory requirements demonstrates a lack of consensus as to donor and/or product infectious disease screening that may inevitably harm patients along with increased costs and delayed product availability. This review article addresses the microbiological attributes, specifications, screening methods, and risk assessment of these unique products and makes recommendations as to the path forward.
Part one of this three-part series examined the scientific basis for recombinant methods and the history and extensive studies utilized previously for the acceptance of alternate tests in the field of pyrogen and bacterial endotoxins testing. As reported in part one, we believe there are three necessary elements to a complete validation of a recombinant method’s ability to assure continued product quality and patient safety.
Dr. Danny K. Chou, PharmD, PhD, Mark Bumiller
Subvisible particulate matter testing in injectable drugs has been required for many parenteral drugs since USP <788> was first implemented in the early nineteen eighties.1 The acceptance criteria has not changed through the years with a focus on particle counts at 10 and 25 µm per container for small volume parenterals (SVP) and large volume parenterals (LVP)
Examining extractables and leachables is an important safety issue as these substances can adversely impact the health of patients.
Gennady Khirich, Ken Skidmore
Nuclear Magnetic Resonance (NMR) spectroscopy is a mature and versatile technology with a vast and rich history.
Kan Wang, Yi Liu, Junxuan Li, Chip White, Ben Wang, Bruce L. Levine
During the COVID-19 pandemic, the delivery of healthcare and the supply chains for critical reagents and supplies needed for the manufacturing both of established and novel therapies have been disrupted. Some critical materials may be unavailable as they could be used to produce COVID-19 related drugs or vaccines. Personal Protective Equipment (PPE), disinfectant wipes, and related materials used in clean room manufacturing facilities are likely to be in short supply for many months, if not longer.
Josh Fyffe, Omkar Kawalekar, Hussain Mooraj
Life sciences companies supplying individualized cell and gene therapies (CGTs) will need to create digital capabilities that orbit around the patient and clinical service providers to achieve market uptake and product sustainability.
Dhanuka P. Wasalathanthria, PhD, Matthew S. Rehmann, Jay M. West, Michael C. Borys, Julia Ding, PhD, Zheng Jian Li, PhD
The typical manufacturing process for biopharmaceuticals includes a cell culture process that generates the molecule of interest (upstream processing), a process to purify the molecule by removing process and product-related impurities (downstream processing), followed by formulation or lyophilization into the final drug product.
Lonza is a contract development and manufacturing organization (CDMO) that provides drug substance and drug product manufacturing services for partner pharma and biotech companies.
Bonnie K. Shum
Advanced data analytics tools are used throughout the biopharmaceutical industry, from leveraging computational biology for drug discovery, to increasing process understanding and improvement through predictive monitoring, to smart packaging and blockchain supply chain, and to targeted patient engagement programs for better treatment outcomes.
Leigh Ford, Vincent Jannin, Hassan Benameur
Drug developers have traditionally benefited from the ionizability of acidic or basic drugs to form ionic salts that increase water solubility.
Michelle Neumeyer
Real-time total organic carbon (TOC) and conductivity testing enables optimized monitoring programs for pharmaceutical grade water systems. With online monitoring, manufacturers achieve better process control, efficiency gains, and risk management for CGMP processes.
American Pharmaceutical Review recently conducted a survey of our readers to determine their thoughts regarding pure water monitoring. Specifically, the survey asked questions regarding Total Organic Carbon (TOC) monitoring, sampling and analysis for purified water production.
José-Miguel Montenegro-Alvarado
This article provides an introductory overview of Multivariate Analysis (MVA) including a brief review of some of its benefits and limitations. The manuscript intends to demonstrate that there may be opportunity to further the use of MVA tools at early stages of investigations as a routine diagnostic tool using medium-sized data sets as part of a more holistic approach to root cause identification. The article then briefly expands on case studies in which MVA tools were leveraged for initial diagnostics and to gather actionable information on potential opportunity areas.
Microbiology Roundtable
Mo Heidaran, PhD, Heath Coats, Kurt Brorson, Steve Winitsky
Novel coronavirus SARS-CoV-2, the causative agent for COVID-19, has disrupted the global clinical trial landscape in just a few short months. This virus is part of a larger family called Coronaviridae, which includes viruses that can infect only animals, cause mild colds or be communicable and pathogenic like the SARS virus of the early 2000’s.
Kevin Williams
If we want to scientifically understand the dynamics of LAL and rFC in terms of equivalency, then we must be able to sort out some conflicting data. Five broad claims have been made by a single LAL manufacturer against rFC which suggest that rFC underestimates endotoxin content.
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 April-May 2020.