B iologic medicines provide needed relief to millions of Americans with arthritis, psoriasis, Crohn’s and other diseases. The medicines, also known as biologics and biopharmaceuticals, are derived from living organisms by programming cell lines to produce therapeutic substances. Common biologics include human growth hormone, injectable treatments for arthritis and psoriasis, the hepatitis B vac...

Introduction According to the regulations and guidelines set by regulatory agencies, including the U.S. Food and Drug Administration (US FDA),1 the European Medicines Agency (EMA),2 extractable and leachable information must be included in applications for medical devices and container closure systems packaging for human drugs and biologics. The specific applications include the New Drug Applic...

License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be f...

Drugs and biologics developed to treat children with cancer have been historically developed in adults for adult indications. Although leading to many useful drugs and biologics to treat pediatric cancer, future development of molecularly targeted therapies (MTTs) should be directed toward pediatric tumors more specifically to maximize antitumor efficacy while minimizing acute morbidity and lon...

License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be f...

Growing numbers of women of reproductive age are prescribed new biological agents. This is resulting in more pregnancies exposed to these drugs. What are the new biologics (also referred to as biologicals) and what are their indications? How are they currently used in pregnant women? What are the concerns when treating pregnant women with biologics? What do we know about the reproductive safety...

Treatment of autoimmune disorders such as psoriasis, rheumatoid arthritis, and Crohn’s disease with so called biologics (selective immunomodulatory drugs) has become a standard way to treat severe or recalcitrant forms of these diseases. In particular, antagonists of tumour necrosis factor (TNF) have been proved to be highly efficacious. In this review we summarise the current knowledge on prob...

The last two decades have witnessed a pandemic in antibody development, with over 600 entering clinical studies and a total of 28 approved by the FDA and European Union. The incorporation of biologics in transplantation has made a significant impact on allograft survival. Herein, we review the armamentarium of clinical and preclinical biologics used for organ transplantation--with the exception...

License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be f...

Joanne Beck, PhD, director of biologics manufacturing, Abbott Research Center Uwe Gottschalk, PhD, vice president, purification technology, Sartorius AG, Germany David W. Kahn, PhD, director, late-stage purification development, Human Genome Sciences, Inc. Duncan Low, PhD, scientific director, process development, Amgen Inc. Jill A Meyers, PhD, principal consultant, BioPro Consulting Charles Sc...