Tools of the Trade
Maslow wrote, "I suppose it is tempting, if the only tool you have is a hammer, to treat everything as if it were a nail." For decades, Pharma's been engineering its own "hammer" creating development and production methodologies that tended to treat every potential drug candidate like the proverbial nail. To many including regulators, Pharma's hammer became too heavy to wield, not only inefficient at driving Pharma's traditional nails but increasingly unsuited when putting together today's sophisticated therapies. As a whole, drug makers may be slow at accepting this, but data does show capital is being invested and retooling continues in response to the market's often crazy complexity. Editor Steven Kuehn gets out there, querying the industry's top technocrats as to the equipment trends they see driving the industry's success.
Management's Role in Sustaining Continued Process Verification
A company gets a 483 warning letter criticizing the company's continued process verification (CPV) approach. In its wake, the company scurries about figuring out how to respond; so Who's at fault? How should this situation be remedied? According to Ronald D. Snee, Snee Associates, LLC the major portion of the responsibility should be management. Addressing CPV has renewed Pharma and Biotech's interest in process monitoring and Dr. Snee offers insight into managing a sustainable CPV effort to help assure regulators of its integrity and efficacy.
Proactive Quality & Compliance
Serialization and the Drug Quality and Security Act
The problem of counterfeit drugs and drug adulteration has been a worldwide issue for decades but now regulators are addressing the issue. The recently passed Drug Quality and Security Act was the result of a multi-year effort to produce balanced legislation, taking into consideration, among other things, stakeholder priorities. Bikash Chatterjee, President and CTO, Pharmatech Associates reviews what companies need to know regarding the DQSA and the Drug Supply Chain Security Act (DSCSA) within it, which outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
Information & Data Management
The Lab of the Future
Steady advances in technology have vastly improved the productivity, performance, and predictability of scientific work in laboratories for life science organizations. But Gene Tetreault of BIOVIA notes many challenges remain. To stay competitive, today's life sciences firms need to implement systems for standardizing the processes that are followed during development, manufacturing, and quality assurance/quality control (QA/QC). Tetreault finds standard processes are critical for establishing efficient lab environments, and that by creating and implementing them, will help life science organizations overcome many of these perennial problems.
Technology at Work
DoE Reduces Bioequivalent Generic Development Time to 4 Months
A generic pharmaceutical manufacturer Pvt. Ltd was recently hired VerGo Pharma Research Laboratories to develop a bioequivalent with different polymorphic forms for an anti-depressant drug that had been patented in crystalline form only. Using conventional one-factor-at-a-time testing methods it would have taken several years to determine the right combination of inactive ingredients to achieve the required in-vitro dissolution and in-vivo plasma drug profile. Author Subrata Kundu, explains how VerGo compressed this development process to only four months by using design of experiments (DOE) to reduce the number of tests required to determine the effects of inactive ingredients on bioavailability in both fed and fasting conditions.
Product round-up from prominent equipment & technology suppliers.
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