Manufacturing

The United States Pharmacopeial Convention (USP) launched a 12-month pilot Technical Assistance Program (TAP) to provide developing countries in sub-Saharan Africa with greater capacity to test the quality of medicines.

President Barack Obama's State of the Union address, delivered last week on Jan. 25, 2011, to the US Congress, was largely well received by the pharmaceutical and biotechnology industries.

Last Friday, Senators Herb Kohl (D-WI) and Chuck Grassley (R-IA) reintroduced their "Preserve Access to Affordable Generics Act," which would presume that pay-for-delay settlements were illegal and give the Federal Trade Commission (FTC) the power to block them.

Company and People Notes: Pfizer Completes King Tender Offer; Cook Pharmica Names VP of R&D and CSO; and More

Chemistry reviewers in FDA's Office of Generic Drugs provide an overview of common deficiencies cited throughout the CMC section of ANDAs.

Deep process characterization and "lab-on-a-chip" enable SMART bioprocess design.

Follow-ons were all the rage at this year's JP Morgan Healthcare Conference.

Industry and regulatory experts discuss the challenges and benefits of implementing real time release testing in a pharmaceutical manufacturing environment.

Government and private sector efforts take on counterfeit drugs online.

New products in tableting and granulation.

As biologic-drug patents move toward expiration in the US, Indian firms with experience in the follow-on biologics arena are eager to partner with global manufacturers and secure their place in the growing biosimilars market.

Legislation has hampered cross-border drug importation and limited choice.

Q&A with Magnetrol International's Dan Klees

Food-safety, transparency, and counterfeit-drug growth will tax agency resources.

More crucial biomanufacturing operations are expected to be outsourced.

Anticounterfeiting solutions for vials and syringes.

Taking care to note, file and re-check information can save one from future mishaps.

How to adapt a real time release approach to powder processing during drug-product manufacturing.

The author describes why statistical significance would impose an unreasonable burden on manufacturers.

The authors modified equipment and the manufacturing process to re-establish content uniformity among tablets.

As the industry prepares for Informex, the trade show of custom and batch manufacturers in Charlotte, North Carolina, a roundup of key recent developments.

Innovations protect the quality of temperature-sensitive products.

A roundtable moderated by Angie Drakulich.

The authors highlight the need for a technology-transfer process that is efficient, cost-effective, and repeatable, stressing the importance of process understanding. Read this and other preferred organization articles in this special issue.

The article examines pharmaceutical market growth, company positioning, and the innovation potential in emerging markets. Read this and other preferred organization articles in this special issue.