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WB Newsletter

News

/In The News
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Michael Weiss’s article in ALN about Transitional Operations:

Four Objectives for Transitional Operations to a New Facility

A consistent drawback of the traditional design/construction process of delivering complex facilities is the inevitable “mad rush” at the end to turn over the facility. Compressed schedules and shifting priorities often leave the occupants ill-prepared to fully operate a new facility or program and require them to make costly adjustments and modify initial Standard Operating Procedures (SOPs) to fit these unexpected conditions.

Read more

 

September 28th, 2016|

FDA Grants “Breakthrough Status” for Promising Cancer Treatment, 60 Minutes Reports

For two years, 60 Minutes has followed the clinical trials at Duke University where a modified version of the polio virus is being used to eliminate brain cancer tumors called Glioblastoma. The FDA had previously approved the trial in humans in 2011, and has recently granted the treatment “breakthrough status” which means that the clinical trials can move more quickly than usual. The second phase of the trial will be expanded to about 40 institutions.

WB | Clinical has been providing a wide range of operational and ongoing compliance services at Duke University to ensure trials like this can go uninterrupted […]

June 2nd, 2016|

US National Cancer Institute stops making cell therapy in light of contamination risk

Cell therapy and radiotracer production has halted at two facilities operated by the US National Institutes of Health (NIH) after consultants raised concerns about quality and manufacturing standards.

Read more on In-Pharma Technologist

April 21st, 2016|

WB | Clinical Selected to Support the National Institutes of Health

In light of serious problems identified in the NIH Clinical Center Pharmaceutical Development Section last year, NIH launched a multifaceted effort to ensure that processes for patient safety and quality of care at the hospital are of the highest standards.  Accordingly, NIH hired WorkingBuildings to evaluate all of its facilities producing sterile or infused products for administration to research participants.

Read the statement on NIH.

April 20th, 2016|

Continuous Mission Alignment with Facility Design Prevents Operational Failures

Transitional services is an emerging field that brings the scientific perspective to complex lab projects to fill the gaps that can arise over a process that might span 10 years from inception to completion.

Read the full report on Tradeline

January 20th, 2016|

Kurt Last Judges Shark-Tank Style Competition

Five companies participated in Kapaa High’s New “Shark Tank”-style Business Competition, where Kurt Last, executive Vice President of WorkingBuildings, was one of the panel judges.

Read the full story on The Garden Island

December 20th, 2015|

USGBC Georgia Chapter is in a Platinum LEED Office

WorkingBuildings Corporate Headquarters earned PLATINUM certification in the LEED for Commercial Interiors v2009 rating system. WorkingBuildings shares their space with the USGBC Georgia Chapter.

Read the full story on USGBC Georgia

December 3rd, 2015|

VGTI Florida Retains WorkingBuildings

The Vaccine & Gene Therapy Institute of Florida (VGTI Florida) today provided an update on the orderly wind-down of its operations. VGTI Florida has retained WorkingBuildings, a leading, international, quality assurance consulting firm with extensive expertise in laboratory management and operations. WorkingBuildings will continue to maintain the facility and all equipment.

Read the full story on Business Wire

October 9th, 2015|

Duke University Undergoing Promising Cancer Treatment Trial, CBS 60 Minutes Reports

60 Minutes followed the clinical trial at Duke University where the modified version of the polio virus is being used to eliminate brain cancer tumors. Glioblastoma is an aggressive form of brain cancer where the tumor can double in size every two weeks if left untreated. It kills 12,000 Americans a year.

The FDA approved a trial in humans in 2011 where the polio virus is injected into the tumor. The polio virus cannot reproduce in healthy cells, but when injected, it releases toxins that poisons the cell and alerts the immune system to attack the tumor. The first two patients […]

April 2nd, 2015|

Getting BSL-3 Labs to Pass Failure Scenario Requirements

Regulatory requirements for using directional airflow as the primary method of containment in BSL-3 labs is a simple concept, however the engineering and controls required for today’s facilities present an array of challenges when it comes to conducting “failure scenario” tests during commissioning and shutdown, and startup procedures during normal operations.

Read the full report on Tradeline

December 4th, 2014|