Articles in this Issue
Angel L Salaman-Byron
Regulatory agencies like the FDA and EMA requires pharmaceutical manufacturing companies to have an EM program and SOPs in place as an important part of the drug manufacturing control process to ensure product safety attributes.
Mark Duerkop, Moritz von Stosch, Martin Mayer, Gerald Striedner
The imperative to reduce process development times and costs, as well as batch-to-batch variation is known across the biopharmaceutical industry; ultimately helping to ensure earlier patient treatment and reduced biopharmaceutical prices.
Angeliki Siamidi, PhD, Sofia Konstantinidou, MPharm
The aim of this investigation is to compare the release behavior of a multiple-unit modified-release formulation of Mesalazine, with dextran as excipient, against powder filled capsules in various gastrointestinal simulated pH media. The results indicate that capsules, when filled with minitablets, release.
Emil W. Ciurczak, Ph.D.
While Near-Infrared Spectroscopy (NIRS) has been used in the pharmaceutical industry since the 1980s, it continues to evolve today. When I first investigated NIRS as a technique, most instruments used were UV/Vis with and “also scans in the NIR” option.
Parenteral final product inspection is challenging for a variety of reasons. The end use initiates the highest level of quality testing for product safety, with even the smallest of sterile barrier defects posing a risk to the patient.
A small variation in the impurity profile, viscosity, particle size, dissolution characteristics, molecular weight etc. of an excipient could have drastic impact on the end performance of a pharmaceutical formulation or process.
John Armando, Valerie Tsang, Kimberly Wolfram, Shannon Holmes, Veronique Bailly
In order to advance lifesaving (or disease modifying) therapies to
patients, the pressures for expedited development are increasing.
Advancements in technology, program needs, and product knowledge
inevitably result in the need for comparability assessments driven by
late stage process changes. The use of enhanced technologies and
risk-based approaches can build robustness in one’s comparability
assessments, improve both product and process knowledge, and
ensure robust continual product supply to patients. As comparability
assessments become increasingly important for evaluating changes
during expedited development or in planning for post-approval
changes, risk-based approaches and increased agency and industry
collaboration are essential enablers for success.
Jeanne Moldenhauer
Advertisements for many on-line educational institutions feature workers in fear of being displaced from their positions by robots and the need for “Information Technology” education. While concern for having positions that will last for your intended working career has been around for a long time, in recent years it has increased significantly. A philosophy of manufacturing called Lights Out or Lights-out-Manufacturing refers to factories or companies that operate fully automated and do not require the presence of humans on site.
FDA is seeing an increased level of interest in continuous manufacturing of pharmaceuticals. Companies are developing continuous processes for the manufacture of drug substance and drug product. Continuous processes are being used for new products as well as for post-approval change of the approved batch process.
Harshada Sant, MS
This article summarizes a novel concept comprising of drug loaded
empty capsule shells, by Dr. Hemant Joshi. The patents titled
‘Physically/molecularly distributed and/or chemically bound
medicaments in empty, hard capsule shells’ summarize the same
capsule dosage form, which contains medicaments in the core matrix
and in the shell.
Anvit Vasavada, M.S, Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, PhD, MBA
The purpose of this column is to highlight
and summarize recent key patents in the
pharmaceutical arena issued by the US
Patent Offi ce in February 2018.