Dosage Forms

Follow-on versions of complex biologics require extensive expertise in development and regulatory procedures.

A technical leader in solid dosage forms Pfizer CentreSource provides analytical, technical, regulatory, developmental, manufacturing and packaging support that spans the specialized realm of highly potent solid oral dose drug products.

Merck and Hanwha Chemical have formed an exclusive global agreement to develop and a commercialize a biosimilar of Enbrel, a drug to treat moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis.

Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.

More sophisticated biological expression systems expand the functionality of the traditional systems for protein synthesis.

Academic–industry partnerships are increasingly important in biopharmaceutical innovation.

FDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.

Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.

Filling active ingredients directly into capsules is probably the quickest option for entering clinical trials. This case study compares manual and automated methods of capsule filling.

FDA is asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications.

The authors develop a pratical approach to avoid unwanted interactions between pepsin and SLS in dissolution Tier II tests.

Emerging methods could provide alternative ways of producing inhalable drug particles.

Innovator and generic-drug companies need to adapt to compete in the biosimilars market.

The authors question certain aspects of the industry's current regulatory-compliance strategy and suggest that aseptic-process control and evaluation should be revised.

A technical forum moderated by Patricia Van Arnum

The IMS institute has released its report on the use of medicines in the United States during 2010.

We want to fill one of our oxygen-sensitive products inside an isolator system. Can we run an isolator with pure nitrogen and defined humidity?

Increased competition, the rising role of emerging markets, and targeted opportunities in niche segments are factors influencing the generic-drug market and related supply base.

An uncertain regulatory environment affects funding for biotechnology.

Regulators question whether particles that they can't see hurt patients.

The authors revisit their previous effort to refine the terms that describe interventions and to dispel confusion that arose after the original article was published.

The aim of this study was to prepare and characterize physiochemically and biologically tamoxifen-loaded SLNs to evaluate their effectiveness as a drug-delivery system to treat breast cancers.

The main challenge for tablet manufacturers processing highly potent APIs (HPAPIs) is to protect equipment operators from the inhalation of airborne particles and prevent skin contact with the product during the entire production process: dispensing, granulation, tablet compression, coating and packaging.

Representatives from Pfizer R&D, DEM Solutions, Colorcon, and ARmark Authentication Technologies provide insight into recent tablet-coating technologies.

Pharmaceutical Technology Europe brings together suppliers of tabletting equipment and excipients to discuss the challenges, innovations and latest trends in the tabletting industry.

The global market for biosimilars is set to grow from $243 million in 2010 to $3.7 billion in 2015, according to research from Datamonitor, an independent industry analyst company.

Novartis has completed the acquisition of a majority stake in Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. — one of the largest privately held vaccines companies in China.

Novartis acquired a majority stake in Zhejiang Tianyuan Bio-Pharmaceutical, one of the largest privately held vaccine companies in China. The acquisition gives Novartis an expanded presence in the Chinese vaccine market and will facilitate the introduction of Novartis's vaccines into the country.

Japan has suspended the use of two pediatric vaccines made by Pfizer and sanofi following the deaths of four children in three days.

Although tablet manufacture is traditionally a batchbased wet granulation process, there are many advantages to be gained by adopting dry granulation, including lower costs and increased yields.