Girish Malhotra, PE
The recent announcement of Amazon, Berkshire Hathaway, and JP Morgan Chase to address rising healthcare costs for their employees has caused a bit of uproar on the healthcare landscape. Healthcare companies and many others have expressed their concern and doubts about success of the partnership. There will be many “naysayers” and many will pontificate. Their concerns could be real but the time for “creative destruction” on the healthcare landscape has come. It has been long overdue.
Jeanne Moldenhauer
Endotoxin results have been a major area of concern, especially in the biologics area due to issues with low endotoxin recovery. In some recent years, there were regulatory concerns about whether we were properly inoculating endotoxin challenge units in oven and tunnel studies, specifically whether we were directly inoculating the surfaces of these units for validation.
Tony Cundell, Ph.D.
This review article analyzes the U.S. Food and Drug Administration (FDA) facility inspection, conducted at Biocon Ltd, Bangalore, India from May 25 to June 3, 2017, in the context of the FDA marketing approval of the biosimilar OGIVRI.
Sofie Pattijn
During the last few years, significant advancement has been made in the clinical application of cancer immunotherapies. Molecules directed against immune checkpoints and other agonists show great promise for treatment of a variety of malignancies.
Recently, American Pharmaceutical Review met with the company’s Vice President of Business Development and Project Management,Mike McDowell, for a tour of their Lancaster facility and to learn more about the company’s capabilities, their state-of-the-art facility and their continued growth.
Johannes Möller, Kim Beatrice Kuchemüller, Tanja Hernández Rodríguez, Björn Frahm, Volker C. Hass, Ralf Pörtner
Biopharmaceuticals are the key drivers for the medication of former untreatable diseases. Trends for the future indicate a 50% market share of the top 100 pharmaceuticals to be bio-based. Approximately 70% of these biopharmaceuticals are produced in suspension using Chinese Hamster Ovary (CHO) cell cultures in large volumes and complex production processes.
Ivelisse Colón, Joseph Medendorp
It is well known that dissolution is an important quality attribute of pharmaceutical dosage forms, not only important during the development phases in order to predict and optimize invivo performance, but also during the commercialization and post-marketing stages of a product. Even for immediate-release (IR) formulations (where the specification for routine quality control testing usually includes Q at a single time-point), reliable information on dissolution profiles is needed to support postapproval changes in accordance to FDA’s SUPAC IR guidance.
Jeremy Springall, PhD
Quality by Design (QbD), as currently applied to the manufacturing of biological and biotechnological therapeutic products, constitutes a systematic approach to product development which aims at consistently delivering safe and efficacious products of known quality to patients.
Caleb Trecazzi, Mark T. Fisher
Protein aggregation is a common deleterious outcome that may occur during the production and storage stages of biotherapeutic protein development. Aggregates are detrimental to drug efficacy, leading to general immunity against the biotherapeutic protein.
Siniša Belina
For any business, in any industry, it’s not how much data you have but what
you’re able to do with it that determines its value. And few organizations
have as much data to manage as life sciences companies, which means
they have the most to gain by honing their data discipline.
Single-use devices have been part of the bioprocessing industry for 20 years, including starting from storage and freezer bags, based on designs from the medical industry.
In general, what are some current issues facing
pharmaceutical companies in regards to cleaning
process verification?
Yunyu (Linda) Yi, Li Zang
Therapeutic mAbs have a propensity to aggregate under a variety of environmental conditions, similar to proteins in biological system. Protein aggregation in biological systems was reported to correlate with age-related or neurodegenerative-related diseases such as Alzheimer’s and Parkinson’s disease.
Dr. Margit Holzer
This article gives an overview of strategies and current technologies that can help to address challenges which arise with the implementation of continuous production of biopharmaceuticals.
Szabolcs Fekete, Alexandre Goyon, Jean-Luc Veuthey, Davy Guillarme, Ph.D.
Size exclusion chromatography (SEC) is a historical technique, routinely applied for the separation of species possessing different molecular masses (sizes). It is considered as a reference method for the qualitative and quantitative analysis of protein aggregates.
Meredith H. Boerschlein, Shana K. Cyr
Pharmaceutical patent litigations between branded and generic drug companies often take place before the generic drug is marketed.
It’s a well-documented fact that the financial cost and time spent to discover, develop, shepherd through clinical trials, and manufacture/package anew pharmaceutical are astronomical.
Anvit Vasavada, M.S, Harshada Sant, MS, Amitkumar Lad, PhD, 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 January 2018.