Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

 is opening a new laboratory to better support fast-track development of pharmaceutical products in Greenville, NC. The new $1.6 million, 4,524 ft

 facility provides additional flexibility for early formulation and analytical method development. The facility is designed for preclinical development of early formulation prototypes and related analytical methods. In this laboratory setting, formulators and chemists will have significant autonomy to conduct development activities more quickly, according to the company. 

The new processing suites will have independent HVAC systems and engineering controls such as interlocking airlock doors, room air pressure differentials, high-volume room air turnover, and 100% HEPA air filtration.The ground floor of the new facility consists of five processing rooms and one analytical laboratory. The second floor consists of workstations, office space, and a conference room. The new facility was expected to be fully operational by mid-February.

Articles

Metrics opens a new laboratory to support fast-track development of pharmaceutical products in North Carolina.

Metrics Expands with Fast-Track Development Laboratory

, a subsidiary of Merck KGaA, reported the appointments of Gary Zieziula as COO, Allene Diaz as senior vice-president of Managed Markets, Lisa Buffington as vice-president of US Communications, Alexander Kuta as vice-president and head of US Regulatory Affairs, and Michael Ruggiero as vice-president of US Government Affairs and Policy.
  
  Zieziula is responsible for increasing the growth of the US organization by controlling the performance of EMD franchises.
  
  Diaz is responsible for developing and executing Managed Markets marketing, sales, and contracting strategies for EMD Seronoproducts. 
  
  Buffington is responsible for executing all aspects of the company’s communications strategy, including external and employee communications, media relations, corporate reputation, product communications, community relations, as well as meetings and events. 
  
  Kuta is responsible for the strategic direction of EMD Serono’s regulatory efforts with the FDA, overseeing regulatory submissions in the US and strengthening interactions with the FDA.
  
  Ruggiero is responsible for federal and state legislative, policy, political, and advocacy strategy and execution for EMD Serono’s business.
  
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EMD Serono Appoints New Leaders

 reported that Pfizer will perform a three-month trial of the company's packaging integrity testing systems based on thermal imaging.  DIR technologies will install a 100% inspection system for exploration of the technology, to potentially replace destructive seal integrity testing across a number of packaging operations to evaluate speed, accuracy, and cost.
  
The Induction Integrity Verification System is testing in-line the integrity of the aluminum foil sealing of induction-sealed bottles. It is the first system capable of inspecting 100% of the bottles undergoing induction sealing, without resulting in production slowdown and providing continuous process verification. The inspection is done through the cap by means of high sensitivity thermal imaging. The system was launched by DIR Technologies at PACK EXPO in Las Vegas in September 2013.

DIR Technologies will work with Pfizer to perform a three-month trial of the company's packaging integrity testing systems.

DIR Technologies Announces Trial with Pfizer for Integrity Inspection System

 has issued a nationwide voluntary patient level recall of Acetylcysteine Solution 10%, USP, Lot 2005479 after the discovery of a single visible glass particle in a vial. There have been no complaints or adverse events related to a piece of glass in vials of this lot. All other product parameters were within specifications, according to a company statement. The recall is limited to a single lot number.


Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretion. Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen.

Ben Venue issues a voluntary patient level recall of Acetylcysteine Solution 10% due to glass particle in vial.

Ben Venue Laboratories Issues Voluntary Recall Of Acetylcysteine Solution

 has changed the name of its Shield Medicare division to Ecolab Contamination Control. In conjunction with the change of name, a new website has been developed, which includes details of all products and services, along with information on the company’s sterile manufacturing processes. Since acquiring Shield Medicare, Ecolab has helped it to develop into a global organization with investments in a number of areas, including a new manufacturing facility, the company reports. 

Ecolab's Shield Medicare division will now be called Ecolab Contamination Control.

Ecolab Rebrands Shield Medicare Division

, a specialty pharmaceuticals company, and Cadence Pharmaceuticals, a biopharmaceutical company focused on commercializing products for use in the hospital setting, have entered into an agreement under which a subsidiary of Mallinckrodt will acquire all outstanding shares of Cadence Pharmaceuticals. The acquisition will be for $14.00 per share in cash or approximately $1.3 billion on a fully diluted basis.

As part of the transaction, Mallinckrodt will acquire Ofirmev (acetaminophen injection), a proprietary intravenous formulation of acetaminophen for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

Subject to customary terms and conditions, the parties expect the transaction to close in mid- to late-March. Mallinckrodt expects the acquisition will be immediately accretive to its fiscal year 2014 adjusted diluted earnings per share, and significantly accretive to its fiscal year 2015 adjusted diluted earnings per share.

Mallinckrodt acquires Cadence Pharmaceuticals for $1.3 million.