Welcome to the April 2012 issue of Pharmaceutical Technology Sourcing and Management, your information resource about the pharmaceutical supply chain. In this issue, analysis of Merck & Co.’s and MedImmune’s biologics manufacturing capacity-sharing arrangement. Also, analysis of the recent ruling supporting compulsory licensing for a pharmaceutical in India. And the latest developments from the bio/pharmaceutical industry relating to corporate social responsibility and sustainability.

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Podcast - Process Validation for Sterile Manufacturing
Join William (JR) Humbert, the Validation Manager at Cook Pharmica, as he discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation.

Biologics
Manufacturing Capacity-Sharing Model: Merck & Co. and MedImmune
Patricia Van Arnum, executive editor of Pharmaceutical Technology and Pharmaceutical Technology Europe and editor of Sourcing and Management
Merck & Co. and MedImmune's manufacturing capacity-sharing model for biologics ushers in a new paradigm of "co-opetition."

APIs
Pharmaceutical Industry Faces Compulsory Licensing in India
Patricia Van Arnum, executive editor of Pharmaceutical Technology and Pharmaceutical Technology Europe and editor of Sourcing and Management.
The decision by the Indian Patent Office to issue a compulsory license for a generic version of a Bayer anticancer drug engenders debate.

Outsourcing
CMOs Face a Kodak Moment
Jim Miller, president of PharmSource Information Services and contributing editor to Pharmaceutical Technology
The evolving bio/pharmaceutical business model poses risk for CMOs.

CSR and Sustainability Forum
Pharmaceutical Technology’s dedicated editorial coverage on the developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, other business sectors, and public and private organizations. This month, we feature articles on a new UN Commission focused on health treatments for women and children and a roundup of CSR and sustainability news.

UN Launches Commission on Life-Saving Commodities for Women and Children
Patricia Van Arnum, executive editor of Pharmaceutical Technology and Pharmaceutical Technology Europe and editor of Sourcing and Management.
A new UN organization focuses on improving the delivery of essential health supplies, including strengthening local production capacities, promoting new technologies and products, strengthening regulatory frameworks, and enhancing innovative financing mechanisms.

CSR and Sustainability in the News
A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.