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Articles and Resources
Aseptic Filling Adjusting to New Paradigm - Complex and Sensitive Drugs Necessitate High-Tech Manufacturing Operations
Featuring, Dr. Michael Frid, Principal Scientist, Wolfe Laboratories, 1 April 2010
"Aseptic filling—the final step before packaging parenteral small molecule and biotherapeutic drugs—represents one of the most technologically innovative and dynamic areas of downstream operations."
Hundreds of Students and Volunteers Join Statewide Biotechnology Job Shadow Day
"More than 350 Massachusetts high school students will spend their day shadowing biotechnology professionals as part of their first-ever statewide Biotechnology Job Shadow Day."
Small Businesses Step Into Spot Light - Wolfe Laboratories Named Eastern Regional Finalist
"These seven small businesses were named regional finalists for the U.S. Chamber’s Dream Big: Small Business of the Year Award, sponsored by Sam’s Club®. One of them will receive the award during America’s Small Business Summit 2010 in Washington, D.C., May 17—19. The award recognizes a company for demonstrating exemplary business practices in the areas of staff training and motivation, community involvement, customer service, and business and financial planning."
For more information, go to www.uschambersummit.com.
Wolfe Laboratories Integrated ADME and CMC Technology Platform
"At Wolfe Laboratories, we believe that integration of critical path drug development activities allows us to help our clients rapidly advance de-risked molecules from discovery into the clinic. ADME, CMC, and Drug Product Manufacturing are essential drug development functions that, if done right, can form the foundation of a highly effective program. Many companies treat these critical path activities as items to be checked off a list, rather than using them strategically to de-risk their drug discovery and development programs." Read more. View case studies.
Wolfe Laboratories on Wikipedia
"Wolfe Laboratories, Inc. (WLI) is a contract research organization (CRO) headquartered in Watertown, Massachusetts. It provides research and development services as well as GLP analytical services for products in late discovery phase through early clinical phases of drug development. It serves clients in New England, the US, and internationally."
Flexibility is the Name of the Game for CROs, Genetic Engineering and Biotechnology News
Featuring, Janet Wolfe, Ph.D., President, Wolfe Laboratories, 15 June 2008
“Wolfe Laboratories is … ‘a bootstrap operation,’ founded nine years ago without any outside investors. [Janet Wolfe] described her company as a niche organization serving “one-compound companies,” mostly in the Boston area. “I focus on biotechs and pharmas that have raised at least $15 million in venture capital…when a molecule is nominated we take it all the way to Phase I, with involvement in critical path activities.”
Regulations Still Driving Stability Testing, Genetic Engineering and Biotechnology News
Featuring, John Augustine, Ph.D., Principal Scientist, Wolfe Laboratories, 1 Apr 2008
… “By the preformulation stage, it may already be too late to set up a stability study,” observes John Augustine, Ph.D., principal scientist at Wolfe Laboratories…
A Brief Introduction to Extractable's & Leachables: Or, Is There Something Extra in My Drug Product?
By Nicole Damour-Krilla, Project Manager, Wolfe Laboratories, 9 Nov 2007
…"as the API and its formulation are optimized, so should the storage conditions, which include the container-closure system... (that) should guarantee the protection, compatibility, safety, and performance of the drug product."
Dose Recovery: Identification of a Problem and its Resolution
By Dr. Nicolas S. Mourier, Principal Scientist, Wolfe Laboratories, 12 Sep 2007
…"compatibility study with these diluents and administration sets from various providers can reveal losses in dose recovery when the test article is evaluated for up to 48 hours at the targeted high and low concentrations."
On Pre-Formulation and Formulation: Defining the Universe of Discourse
By Dr. Michael Frid, Principal Scientist, Wolfe Laboratories, 5 May 2007
… "pre-formulation refers to the physicochemical characterization of a compound and formulation refers to the development of a customized dosage form for a specific administration route."
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