Sancilio & Company, Inc. (SCI) opened its newly expanded 2,000-sq.-ft. contract manufacturing facility. The GMP facility specializes in small batch manufacturing of tablets and capsules as well as packaging and labeling services.
   
The facility is adjacent to the company’s pharmaceutical laboratory, a climate-controlled facility for pharmaceutical, biotechnology and nutraceutical clients providing analytical services, which include formulation development, quality control, quality assurance and regulatory affairs.
   
According to Fred D. Sancilio, Ph.D., chief executive officer and chief scientist of SCI, “The new, fully cGMP compliant combined operation is FDA registered, and licensed for DEA Schedule 2, 3 and 4. The key attributes of both the manufacturing facility and the laboratory are rapid turnaround and competitive pricing.”
   
Nealie Newberger, Ph.D., vice president of laboratory services, said, “We anticipate that the addition of small batch contract manufacturing to our roster of services strategically positions the company as a full-service pharmaceutical and nutritional enterprise.”

The Centers for Disease Control and Prevention (CDC) will implement Pilgrim Software's automated platform for document control, complaints and corrective and preventive action (CAPA) systems management throughout the Laboratory Response Network (LRN) under the Division of Bioterrorism Preparedness & Response.
   
Pilgrim's SmartCAPA solution is a web-based, closed-loop system that allows users to investigate and resolve an issue and prevent recurrence. SmartCAPA will be integrated with the CDC’s internal LRN Website where complaints and product deviations are currently recorded. The complaints will then funnel into the SmartCAPA solution where they will automatically be routed through a closed-loop Investigation and CAPA process for follow-up and resolution.
   
The SmartDoc™ Solution helps organizations create, manage and share critical documents and best practices. SmartDoc will automate the review, approval and change management of controlled documents used throughout the LRN, and all current documents will be made available through the LRN Website.
   
“In selecting Pilgrim’s SmartSolve system, the LRN will elevate the harmonization and streamlining of processes that increase efficiency and enable quicker response to internal and external needs and expectations,” said Prashanth Rajendran, Pilgrim’s chief operating officer. “With the efficiencies it gains, the LRN will further solidify its reputation as a responsive division of the CDC.”

Biogen Idec initiated a Phase III trial of intravenous (IV) Adentri (BG9928), an adenosine A1 receptor antagonist for acute decompensated heart failure (ADHF) patients with renal insufficiency. The trial will evaluate Adentri — developed under a licensing agreement with CV Therapeutics — against placebo in addition to standard of care in approximately 900 patients in 21 countries globally, including the U.S.
   
The TRIDENT-1 (TReatment with Intravenous BG9928 for patients with acutely DEcompensated heart failure and reNal insufficiency Trial) study is a randomized, multi-center, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of IV ADENTRI dosed as many as five days on body weight in ADHF patients with impaired renal function. Body weight is a measure of fluid accumulation, which is considered an important cause of symptoms experienced by heart failure patients.
   
“In previous clinical studies, ADENTRI has exhibited the potential to optimize fluid management without harmful effects on renal function. Heart failure patients with renal insufficiency are at risk for poor clinical outcomes and are among the most difficult to treat, as currently available therapies negatively impact renal function,” said lead investigator William Abraham, M.D., Professor of Internal Medicine and Director of the Division of Cardiovascular Medicine, The Ohio State University Medical Center.

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