Representatives from Merck, Pfizer, and Novartis shared their recent efforts in applying quality-by-design (QbD) concepts to analytical methods, and Todd Cecil from USP explained the related new draft USP chapter in a symposium at Pittcon on Monday, March 18, 2013. The session, “Understanding Analytical Method Variance and the Impact for QbD Filing for Pharmaceutical Products,” was sponsored by the American Chemical Society’s Division of Analytical Chemistry (ACS ANYL) and the American Association of Pharmaceutical Scientist’s  Analysis and Pharmaceutical Quality Section (AAPS APQ). Read more »

Pharmaceutical Technology and Patheon are partnering to provide you—our readers—with CMC advice from some of the leading formulation scientists and pharmaceutical manufacturing experts in the world. To get started, we need to know what plagues your CMC strategies and daily work. Email your questions directly to Editorial Director Angie Drakulich at adrakulich@advanstar.com. (*Note: We will keep your name and company affiliation anonymous.)

Answers will be provided by the Patheon Certified Consultants team beginning in the January 2013 print and online editions of PharmTech. These experts have collectively brought more than 200 pharmaceutical products to market, including some of the world’s largest blockbusters.

Sample questions:

• I have a BCS Class II compound for which amorphous solubility is easily sustained, but I can’t get the compound to rapidly dissolve. What are some solutions, particularly with respect to excipient selection?
• I have a compound that is non-ionizable and does not form a stable salt. Are co-crystals my best option and what are the key criteria in identifying a suitable co-crystal?
• I am having trouble maintaining product stability when scaling up a lyophilization process. What are the likely factors causing the problem?

Guest blog by Ben Comer of Pharmaceutical Executive.

The pharmaceutical industry still lags other industries in spending on outbound social media programs that engage customers directly, but they are – at least Big Pharma is – spending more on so-called inbound social media software and analytics, which lets them listen to what is being said online about brands and unmet needs and match that up marketing strategies. Read more »

The revised US Pharmacopeia revised chapters on elemental impurity limits and procedures (<232> and <233>) are set to become official by the end of the year, and companies are beginning to think about implementation, which will be required by May 2014 (see back story).

According to the latest update from the USP website, the new chapters will be published in the Second Supplement to USP 35–NF 30 (official Dec. 1, 2012). Conformance with these chapters will be required by May 1, 2014. In the interim, all references to USP General Chapter <231> Heavy Metals will be removed from monographs in the compendia.

The International Conference on Harmonization (ICH) Working Group on Elemental Impurities is simultaneously working to develop a harmonized approach for controlling these impurities, including risk-assessment recommendations and safety limits for specific metals, that meet testing and regulatory filing requirements at the global level. USP has noted that its expert panel is not waiting for the final recommendations from the ICH Q3D Expert Working Group but does note that the limits in the new General Chapter <232>, except for mercury, are in line with those in the stage 2 draft of the Q3D guideline. “At a future date, the Expert Panel intends to revisit General Chapter <232> relative to the Step 4 outcome of ICH Q3D deliberations,” says the USP elemental impurities webpage.

PharmTech is hosting and moderating a free educational webinar about the revised USP chapters on June 14, 2012, with a specific focus on new testing procedures and practices for detecting elemental impurities. Instrumentation, key challenges, best practices, and will be addressed.

Register for the free webinar

This blog post was written by Lynn D. Torbeck

Textbooks and journal articles treat common cause variation as if it is an inevitable fact of nature and beyond our control: “In any production process, regardless of how well-designed or carefully maintained it is, a certain amount of inherent or natural variability will always exist. This natural variability or ‘background noise’ is the cumulative effect of many small, essentially unavoidable causes” [Emphasis added]. This attitude cuts off thoughts of trying to reduce variation. But, with some reflection, there are several ideas and techniques that can begin to help reduce common cause variation. Read more »

Biopharmaceutical characterization—especially of unknowns—is becoming far more complex and far higher on the regulators’ radar.  Of particular interest for industry is compliance with harmonized guidelines that address FDA’s concept of a “well-characterized biological product,” which involves being able to measure and control the product’s identity, purity, impurities, potency, and concentration. Read more »

As the unemployment rate hovers around 9.1%, the federal government needs to find ways to create jobs. Congress is debating whether a tax break on repatriated money would prompt companies to hire more workers, as I mentioned last week. Meanwhile, the Obama administration is eyeing another potential means of stimulating job growth: investing in biological research. Read more »

Drug shortages are an acute problem that keeps getting worse. Last year, about 211 drugs were in short supply, which was a new record. This year, the number of new drug shortages already has reached 213, according to the University of Utah Drug Information Service. As a result, many patients now have limited access to crucial drugs, such as cancer therapies and medicines for potentially lethal infections. And a Congressional committee is now investigating what appears to be an insult added to this injury. Read more »

Concern about pharmaceuticals in our water supply has been in the public consciousness for a few years now. In 2009, the Environmental Protection Agency found traces of various drugs in fish caught in rivers that receive effluent from wastewater-treatment plants. The drugs were believed to come from doses that people had excreted or flushed down the toilet. In response, FDA updated its guidelines for disposing of drugs. New research, however, shows another potential source of drugs in our waterways. Read more »