Articles in this Issue
Friedrich von Wintzingerode
The term “Biologics” is used for a class of therapeutics that are produced
by recombinant DNA technology and generally fall into three major
categories: (i) therapeutic proteins, (ii) monoclonal antibodies (mAbs),
and (iii) antibody-drug conjugates.
David P. Elder, Stephen Tindal
The International Conference on Harmonization (ICH) M9: Biopharmaceutics Classification System-based Biowaivers,1,2 was adopted in mid-June 2016. A biowaiver allows for in vitro testing to be used in lieu of in vivo bioavailability and/or bioequivalence studies to facilitate product approval, where solubility and permeability are not expected to impede bioavailability.
Mark C. Arjona, Michael Lau
Distek has developed a benchtop scale SUB system for mammalian cell growth and recombinant protein production.
Charles Mitchell, Shana K. Cyr, Jennifer Roscetti
On March 23, 2020, hundreds of approved and pending applications for biological products will face a regulatory transition as the U.S. Food and Drug Administration (FDA) implements the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
Yihua Bruce Yu, PhD, Yue Feng, PhD, Marc Taraban, PhD
In a typical pharmaceutical solution, water is 103 – 106 more concentrated than the API, which is fully surrounded by water molecules. This provides an opportunity to use spectroscopic signals from water to assess the quality of pharmaceutical solutions. In this article, examples of using the water proton NMR signal for chemical analysis are presented.
Ingo Spreitzer
At the beginning of the 20th century the first commercially available infusion/injection solutions were administered to patients. Pyrogenic side effects termed “Injection fever” or “water fever” (associated to the diluent) were described occasionally. As a consequence the Rabbit Pyrogen Test (RPT) was implemented into the British pharmacopeia (1912), the United States Pharmacopeia followed in 1942.
How have advances in raw materials functionality, supply and quality affected the pharm/biopharma industry?
David Lewis, Tim Rouse, Dilraj Singh, Stephen Edge
The lung is an established route for the delivery of drugs to patients with a wide range of inhaled products being available to treat respiratory conditions such as asthma, chronic obstructive pulmonary disease, and cystic fibrosis.
Qiang Shi, William B. Mattes
Drug-induced liver injury (DILI) remains a persistent problem in medical practice and medical product development, complicated by the multiple mechanisms by which liver injury (hepatotoxicity) can be elicited as well as differences between species.
Nigel Walker
The race for the liquid biopsy is on. The industry is still looking ahead
to what will undoubtedly be the next big thing in oncology screening,
the biopsy blood test. A liquid option is not only more appealing to
patients, allowing those to get screened for cancer on a much more
regular basis, but it will also enable those who are affected by the
disease to progressively monitor their condition.1
Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
Amyloid Binding Agents; J. Yang, and E.A. Theodorakis; The Regents of the University of California; U.S. Patent # 9,551,722; January 24, 2017. The patent provides the compounds, methods for detection and treatment of disease related to amyloid based neurodegenerative diseases.