"The better we understand the relationship between process parameters and product attributes, the better control we'll have over product quality," said Beth Fowler, PhD, during Tuesday?s session on process monitoring at the AAPS Annual Meeting.

At the plenary session at the AAPS Annual Meeting, two researchers presented studies targeting completely different areas of stem cell research, but their work focused on the same ultimate goal: finding new therapies.

Pressures to save API are driving formulation developers toward smaller-scale laboratory processes, while pressures to save time put a premium on more- accurate laboratory scale tools.

"In my experience, you can generally tell where a person stands on the issue by the example he gives," said Art Mlodozeniec, PhD, a panelist at the Nov. 7 roundtable on follow-on biologics at the AAPS Annual Meeting in Nashville, Tennessee. "If he brings up human growth hormone and says the processes and impurities are easy to control, he's from the generic industry and supports approval for follow-on biologics. If he brings up the challenge of of erythropoeitin, he's from the innovator industry and opposes generics."

Contract services providers gained a valuable look into major market conditions, offshoring trends, and 2006 growth opportunities during a morning presentation entitled "CMC Sourcing in transition: Consolidation, Offshoring, and the Market Outlook," presented by Jim Miller. Miller is president of PharmSource (Springfield, VA, www.pharmsource.com), publisher of the Bio/Pharmaceutical Outsourcing , and contributing editor of Pharmaceutical Technology.

Thermo Electron (Waltham, MA, www.thermo.com) debuted the "LCQUAN 2.5" data-acquisition system at the AAPS Annual Meeting and Exposition on Monday. The new system expands the software offerings for the company's "Finnigan TSQ Quantum" series of triple quadrupole mass spectrometers.

"We must add our light to the sum of lights," declared Ron Reagan in his Nov. 6 keynote address to the 2005 Annual Meeting of the American Association of Pharmaceutical Scientists. He was quoting Billy Kwan, the half-Indonesian, half-Australian photojournalist of divided loyalties in the 1982 film, "The Year of Living Dangerously," a character who redeems himself by taking bold action in the face of moral crisis. Reagan encouraged the audience to take similar action to defend science, which he said is currently subordinated to political convenience.

Palatinit's "galenIQ" is line of multifunctional excipients that offer the combined advantages of other bulk excipients.

Roche Puts Hold on Tamiflu in US

New FDA Guidance on Electronic Common Technical Document Submissions

US District Court Rejects FDA Suit to Block Device Manufacturer

Novartis Purchases Chiron in a Total Buyout

USP monographs, if they are consistently observed and applied, can help reduce medical gas errors.

"It was just after FDA had initiated the Pre-Approval Inspection process," reports our GMP Agent-in-Place.

Oddly for a technical meeting, the Oct. 5–7 AAPS Workshop on Pharmaceutical Quality Assessment focused on words, with an entire session devoted to definitions and countless discussions of meaning and nuance.

As industry moves to real-time feedback control, even conventional syntheses will increasingly resemble living systems.

Moheb Nasr, PhD, director of the newly created Office of New Drug Quality Assessment at the US Food and Drug Administration (Rockville, MD, www.fda.gov), has proposed creating a "regulatory agreement" between FDA and sponsors to govern the chemistry, manufacturing, and controls (CMC) sections of new drug applications (NDAs).

The pharmaceutical industry can leverage best practices from the extremely competitive semiconductor market.

Making active pharmaceutical ingredients (APIs) requires long chains of chemical reactions and large quantities of solvents. Ask API manufacturers how they'd like to improve this process, and the responses are likely to be "make the reactions faster," "make the reactions cheaper," or "make the reactions more efficient." Then after all these economically driven answers, you might here, "make the reactions more environmentally friendly."

Recent advances in transdermal technologies challenge the paradigm that only a few drugs can be delivered transdermally.

Information technology can streamline compliance and increase operational efficiency and quality.

The EU ATEX Directive 1999/92/EC (ATEX 137) regarding the minimum requirements to protect the health and safety of workers potentially at risk from explosive atmospheres came into European law in January 2000. In the UK, the ATEX 137 Directive has been implemented as part of the Dangerous Substances and Explosive Atmospheres Regulations (DSEARs), which were issued in December 2002.

The human race will have colonized Mars long before the pharmaceutical industry brings itself into the 21st century.

A range of insect exterminator equipment has been developed to improve the level of hygiene offered to the pharmaceutical and chemical manufacturing sectors. Berson's Insectron range uses ultraviolet (UV-A) and green light to attract flying insects, which are sensitive to these light sources.

Sigma-Aldrich Fine Chemicals (SAFC) has set up a new business division called SAFC Biosciences to encompass its biopharmaceutical development and cell culture-related manufacturing services.

Biomanufacturing managers believe the current lack of adequately trained personnel is one of the most serious problems facing the biomanufacturing industry.

Lester Crawford, FDA's top man, has resigned explaining that it was time to step down — despite only being promoted to commissioner earlier this year.

FDA's Evans Reviews Causes of Warnings and Recalls