Manufacturing

Roche Selects 12 Potential Manufacturing Partners for Tamiflu

FDA issues a warning letter to Nephron Pharmaceuticals.

SEC Loosens Revenue-Recognition Rules for Vaccine Stockpile Participants

NIAID Boosts Vaccine Innovation but Draws Controversy

The monopoly held by the large pharmaceutical companies within drug discovery could be falling into the hands of biotechnology firms claims Frost and Sullivan.

The survival of Bacillus subtilis spores in dicalcium phosphate, lactose, and corn starch and in their binary mixtures depends on the compressional properties of these materials and on parameters involved during the tableting process, including compression speed.

From politics to paychecks and downsizings to deadlines-what it's like to work for one of the world's largest industries.

If judges and juries lack the scientific knowledge to decide drugsafety cases, how can we protect both companies and patients?

CDER is reorganizing staffs and developing new policies to encourage industry adoption of quality production systems.

Particle shape is an important parameter to monitor in the pharmaceutical sector, but has, historically, been too complicated to measure and be utilized on a routine basis. A newly developed digital technique could change this.

In applying a visually clean standard, any residue related to the cleaning process that is visible on the surface should constitute a failure.

OTC Eye-Drop Maker Signs Consent Decree

Merck to Close Plants, Slash Jobs, Streamline Manufacturing

American Pharmaceutical Partners to Merge with American BioScience

Almost all pharmaceutical manufacturing processes require handling and processing cohesive powders. The application of sufficient shear (i.e., the total deformation that the bulk of granular material undergoes under applied shear stress) is an essential factor in such processes. Sufficient shear is required to mill and de-lump materials, achieve sufficient flow, and homogenize cohesive ingredients. Shear mixing plays a critical role in the blending of dry powders, particularly for those that contain a minor cohesive component such as a solid lubricant or a drug. This mechanism is necessary to achieve a satisfactory homogeneity and disintegrate possible agglomerates. Excessive shear can be disadvantageous, however, and can lead to electrostatic buildup, attrition, and overlubrication.

Solid oral drug products are one of the oldest of all manufactured dosage forms (1). Today, the development of an appropriate formulation of drug and excipients and of an effective manufacturing process to create a tablet or capsule is slowly transforming from a practice of applied art to one of applied science. The US Food and Drug Administration supports this change by expecting sponsors of new drug applications to understand, describe, and control materials and processes as well as the risks associated with drug product manufacturing (2). These steps will ensure the consistent production of products that meet their specifications and remain safe and effective during their shelf life.

The potentially huge demand for vaccines in light of the growing avian flu crisis...

Pfizer to Shut Parsippany Plant

Adjuvant for HPV Vaccine Enhances Immune Response Levels

Chiron Looks to Flu Vaccine Cell Culture; FDA Gears Up

Continuous manufacturing processes?little used in the pharmaceutical industry but the norm in oil, food, chemical, and polymer manufacturing?go hand-in-hand with the current emphasis on quality-by-design and automated process monitoring and control (aka, process analytical technology, PAT).

The process analytical technology (PAT) initiative has been percolating at the US Food and Drug Administration for a long time, explained FDA's John E. Simmons at the AAPS Annual Meeting and Exposition on Wednesday. "If you think of PAT as an isolated set of applications, I think you are missing the point," Simmons said. "The FDA would like PAT to become commonplace?not to be an initiative, but common practice."

This week, the US Food and Drug Administration posted an Oct. 20 Warning Letter (http://www.fda.gov/foi/warning_letters/g5567d.htm) sent by its Minneapolis, MN district office to Diversified Manufacturing Corporation (Newport, MN).

Control Development's (South Bend, IN, www.controldevelopment.com) blend uniformity and dryer monitor consists of a NIR spectrometer, a sampling head, computer, and software.

Generally, tablet and capsule film coatings are applied as aqueous or organic-based polymer solutions or dispersions, graduate student Sagarika Bose (University of Connecticut) explained during her Tuesday AAPS Graduate Student Symposium presentation, "Development and Evaluation of Solventless Photocurable Pharmaceutical Film Coating." However, organic film coatings can be flammable, toxic, and must comply with strict environmental regulations. Aqueous film coating can lead to the degradation of certain drugs by heat and water.

"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."

When it comes to developing a robust lyophilization process, formulators can "pay now or pay later," says Jeff Schwegman, PhD, founder and chief scientific officer for BioConvergence. Because 30% of new drugs in clinical trials are biotech-based therapeutics (compared with 7% 10 years ago), more than ever, the US Food and Drug Administration is paying close attention to lyophilization data and questioning pharmaceutical companies about their development cycles, especially cycle development transfer, shelf-temperature mapping, dryer-to-dryer comparison studies, formulation time, process validation, and cycle deviation. Consequently, this is pushing formulators to optimize formulation variables, conduct additional testing during early-stage development, and understanding critical process parameters, equipment qualifications, and manufacturing conditions that can influence formulation behavior at a large scale. Not taking the time or effort to achieve these goals during early development could lead to redundancies in formulation work - a reality observed too often in today's practices.