Andrea Wagner, PhD, SVP, Business Development, BSM Less than 10 years ago you needed different filling equipment for vials, syringes and cartridges. The ability to buy and install isolators for each of these separate operations in a CMO was cost prohibitive. Companies that had high volume production of one product with one type of container… continue reading
By Andrea Wagner, PhD, SVP Business Development Recently Phil Burns wrote an article in Contract Pharma about utilizing contract manufacturing organizations (CMOs) to assist companies to reduce their stress in production requirements.   He stated that CMOs can help companies with immediate and distant manufacturing needs but they need to consider several areas prior to choosing… continue reading
“The Development of an Isolator Based Flexible Filling System for all Containers” Primary parenteral packaging has for years been produced in bulk and sold to pharma companies, where the bulk packaging was washed, sterilized, filled and sealed. This arrangement required different types of processing and filling equipment at the pharma companies for each type of… continue reading
Tech, health care, manufacturing firms honored for contribution to Mass. economy By Megan Woolhouse Globe Staff November 19, 2015 Growing technology, health care, and manufacturing companies dominated this year’s MassEcon Economic Impact Awards, an annual event honoring businesses that have “made an outstanding contribution to the Massachusetts economy.” This is the 12th year the Watertown… continue reading
Berkshire (US) – Berkshire Sterile Manufacturing (BSM), a bio-pharmaceutical startup with 16 employees and plans to hire approximately 20 more in the coming year, has just finished the construction of state-of-the-art clean rooms, quality control and microbiology laboratories, workrooms for product formulation, final inspection, and packaging. The new Berkshire Corporate Center is equipped with the… continue reading
Summary of presentation by Doug Kovacs, Supervisory Investigator, FDA- New Jersey District At the recent Contract Pharma show, hosted in New Brunswick, NJ, Doug Kovacs spoke about the top 10 483 observations in 2014. His focus was on sterile manufacturing facilities and how this compared to 2009. In this summary only the items that FDA… continue reading
On September 10th BSM’s CEO and head of engineering travelled to Sellersville, PA for the ceremony which marked the opening of Fedegari’s new technology center in the U.S.A. We heard from speakers within the industry, including the Italian consulate in Pennsylvania, about the new center and its mission.   The center will give “hands-on” training to companies… continue reading
LEE, Mass. – In just a matter of weeks Berkshire Sterile Manufacturing’s (BSM) warehouse space in Lee has been transformed into clean rooms – and several Berkshire Community College (BCC) students will have played a role in the transformation, according to a news release. BSM, which provides the safest sterile drug products possible for clinical… continue reading
Berkshire Sterile Manufacturing (BSM) is named Finalist for the 12th Annual Team Massachusetts Economic Impact Award for the expansion of its operations in Lee. As background, the Team Massachusetts Economic Impact Awards have been presented since 2003 to honor companies that have made a significant impact on the Massachusetts economy. Past honorees have included IBM,… continue reading