Pharmaceutical Technology-05-02-2013

Pharmaceutical Technology

ZFN Technology Advances Biopharmaceutical Manufacturing

May 02, 2013

BioForum

37

5

Applications of ZFN technology in biopharmaceutical cell-line engineering.

Should Regulation of Combination Products Become More Centralized in Europe?

May 02, 2013

Regulation & Compliance

37

5

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

Academic and Public Partnerships in Solid-State Chemistry

May 02, 2013

API Synthesis & Manufacturing

37

5

Solid-state chemistry is an important part of drug development, and public research is advancing the field.

New First-to-File Patent Rule Threatens Open Collaboration

May 02, 2013

Industry Perspectives

37

5

New US patent rules change the playing field for open innovation.

Co-Opetition in Drug Development

May 02, 2013

Industry Perspectives

37

5

The author suggests co-opetition as a future model for collaboration in drug development.

Using Thermal Ink-Jet Printing Technology to Produce Pharmaceutical Cocrystals

May 02, 2013

API Synthesis & Manufacturing

37

5

Cocrystals are used to improve the performance of APIs that have non-ideal physiochemical properties by cocrystallizing the API with a second compound that modulates the API to provide a way to improve a drug's bioavailability, stability, and processability.

Regulatory Roundup

May 02, 2013

Regulation & Compliance

37

5

FDA faces budget crunch; Supreme Court hears key cases

Facility Trends: Modularization and Single Use

May 02, 2013

Special Report

37

5

Pharmaceutical Technology spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design.

Understanding ICH Q11—FDA's Guidance on the Development and Manufacture of Drug Substances

May 02, 2013

Peer-Reviewed Research

37

5

The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.

Pharmaceutical Technology, May 2013 Issue (PDF)

May 02, 2013

Issue PDF

37

5

Click the title above to open the Pharmaceutical Technology May 2013 issue in an interactive PDF format.