03/14/2017

"Examining FDA’s New Quality Agreement Guidance"

Bikash Chatterjee, President & Chief Science Officer

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02/01/2017

"FDA’s New Quality Agreement Guidance-What it Says (and What it Fails to Say)"

Bikash Chatterjee, President & Chief Science Officer

In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.

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12/01/2016

"Successfully Filing a Combination Product: Lessons Learned"

Bikash Chatterjee, President & Chief Science Officer

In the therapeutic drug landscape, combination products are one of the bright spots, with new and innovative drugs and effective delivery systems joining to bring improved medicines to a wide public. “Combo products” are composed of any blend of a drug and device. Bikash Chatterjee describes several areas that commonly impact combination product development and represent regulatory risk.

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11/04/2016

"Design Space Development- How (And When) To Get Started"

Sandra Wassink, Principal Process Engineer

In early-stage product development, the challenge of finding the optimal design space is determining what is important to achieve consistent product quality. A stepwise approach should be taken in the formulation and development process to capture characteristics or attributes that could impact product quality.

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09/15/2016

"Avoid an FDA Warning Letter in the Laboratory Environment"

Richard Aleman, Vice President, Regulatory Compliance

The FDA’s emphasis on laboratory audits in recent years has focused on companies confirming that laboratory data is not fraudulent. With the rise in evidence that justifies the FDA’s fraudulent data concerns, especially internationally, the failure of companies to provide established historical information and ensure compliance on the validation of their analytical methods and procedures increases the risk of receiving an FDA warning letter.

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07/21/2016

"Managing Cold Chain Distribution Across the Global Supply Chain: Regulations and Trends"

Bikash Chatterjee, President & Chief Science Officer

Supply chains now span the globe and are increasing in complexity as organizations move away from regional business models to manufacturing and distribution on a world scale.

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06/08/2016

"Effective Risk Management: A Catalyst for Quality Performance"

Bikash Chatterjee, President & Chief Science Officer

When we think of risk in the context of drug development and manufacturing, it is human nature to associate any risk-based approach with adding risk to the decision or process. However, when the FDA first introduced the concept of using risk as a component of the new definition of quality in 2004,1 the vision was to manage risk by coupling it with scientific understanding of process and product design for optimal product performance.

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05/12/2016

"Held Hostage!"

Bikash Chatterjee, President & Chief Science Officer,

The threat to intelligent medical devices is compounded by the now-frequent ransomware attacks on healthcare and research organization networks. Bikash Chatterjee’s article in Controlled Environments magazine details the problem and remedies suggested by recent FDA guidance.

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07/24/2015

"Personalized Medicine, Companion Diagnostics, and NGS Diagnostic Tests"

Bikash Chatterjee, President & Chief Science Officer

Pharmatech’s Bikash Chatterjee writes that to realize the promise of personalized medicine requires a shift in the way the pharma/biotech industries define quality, efficacy, and safety in personalized drug therapies and in their companion diagnostics.

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01/01/2015

"Preparing for the Drug Quality Security Act"

Bikash Chatterjee, President & CSO

In November 2013 the President of the United States signed a bill called H.R. 3204 into law. This was the culmination of a decade of state and regulatory agency negotiations to tackle the disparity
in interstate drug traceability.

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