Dissolution Solutions Network

News, Stories and Commentary from the Pharma Lab

Biotechnology Funding Hits 4-Year High While Startups Seek New Investments

Posted on | January 23, 2012 | No Comments

“Venture capital investment in biotechnology increased 22 percent last year, while the number of those receiving their first funding declined. Funding for medical-device and equipment companies also rose 20 percent, with first-time funding falling to a 16-year low, the National Venture Capital Association and PricewaterhouseCoopers LLC said today in a report…more

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US FDA’s 2011 guidance documents round-up

Posted on | January 12, 2012 | No Comments

“The US Food and Drug Administration (FDA) will soon start asking drugmakers to play a greater role in guideline development . Before that process begins in-Pharmatechnologist.com takes a look at the documents published by the agency in 2011…more

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Charles River considering sale, media report claims

Posted on | January 10, 2012 | No Comments

Charles River is reportedly considering selling the business, with private equity and rival companies believed to be possible buyers…more

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Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products™

Posted on | January 4, 2012 | No Comments

Complex processes yielding complex products such as biologics and biopharmaceuticals demand numerous, non-compendial, and sometimes complex, QC test methods to confirm manufacturing consistency and product quality.  This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays.  This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC in biologic and biopharmaceutical companies.  The course will cover validation of QC analytical test methods (e.g., electrophoretic, HPLC, peptide mapping, etc.), cell-based potency bioassays, immunochemical binding impurity assays and adventitious agent assays…more

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Who is Assay Depot?

Posted on | September 13, 2011 | Comments Off

Since the marketplace offers services that span the entire drug discovery process, Assay Depot has the goal to ultimately make it possible for a company (or even a single scientist) to run a multi-year drug discovery program from a laptop computer That day is not too far off.

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FDA outlines regulatory science strategic plan

Posted on | August 19, 2011 | Comments Off

The FDA has drafted and published a plan to modernize regulatory science. The plan, published earlier this month, is titled “Advancing Regulatory Science at FDA”. In it the agency identifies three key areas of emphasis. These include new approaches to manufacturing and quality, development of new analytical technology and development of novel methodologies for detection of contaminants…more

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