Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

(NIH), 10 biopharmaceutical companies, and several nonprofit organizations have formed a partnership to transform the current model for identifying and validating the biological targets of disease for new diagnostics and drug development.
  
  The Accelerating Medicines Partnership (AMP) aims to distinguish biological targets of disease most likely to respond to new therapies and characterize biological indicators of disease, known as biomarkers. Through the Foundation for the NIH (FNIH), AMP partners will invest more than $230 million over five years in the first projects, which focus on Alzheimer’s disease, type 2 diabetes, and the autoimmune disorders rheumatoid arthritis and systemic lupus erythematosus (lupus).
  
  A  crucial element of the partnership is the agreement that the data and analyses generated will be made publicly available to the broad biomedical community. The three- to five-year, milestone-driven pilot projects in these disease areas could set the stage for broadening AMP to other diseases and conditions.
  
  As a result of technological revolutions in genomics and imaging, researchers have been able to identify many changes in genes, proteins, and other molecules that predispose to disease and influence disease progression. While researchers have identified thousands of such biologica lchanges, only a small number have been pursued. Choosing the wrong target can result in failures late in the development process, costing time, money, and potentially, lives, according to NIH.
  
  Development of AMP began two years ago, with interactions between scientists in the public and private sectors, progressive refinement of the goals, strategy development support from the Boston Consulting Group, and scientific project and partnership management by the FNIH. Through this effort, AMP partners have developed research plans and are sharing costs, expertise, and resources in an integrated governance structure that enables the best-informed contributions to science from all participants, according to NIH.
  
  Steering committees with representation from public- and private-sector partners will be established for each disease area to oversee the research plans. These committees will be managed by FNIH under the direction of an AMP executive committee comprised of leaders from NIH, biopharmaceutical companies, FDA, and patient advocacy organizations.
  
Source: 

Articles

NIH, 10 biopharmaceutical companies, and several nonprofit organizations form a partnership to develop new treatments earlier for Alzheimer's, type 2 diabetes, and autoimmune disorders.

NIH, Biopharmaceutical Companies, Non-profits Work to Speed Validation of Disease Targets

, the life-science division of Merck KGaA, has introduced the Drypour packaging system, which minimizes caking during transport and storage of hygroscopic salts used in pharmaceutical manufacturing. The system, which consists of a polyethylene drum with a tamper-evident seal, apolyethylene liner with integrated desiccant bags, and a breathable interior Tyvek liner, helps improve operational efficiency by reducing the time and effort needed to break up heavily caked raw materials, according to the company.
  
  The drum and polyethylene liner prevent outside moisture from entering the product.  Any water vapor in the product itself can permeate the interior, tear-resistant Tyvek liner, migrate into the outer polyethylene liner and be absorbed by the integrated desiccant.  Unlike other packaging systems, the desiccant bags in the Drypour system are fixed to the perforated polyethylene liner, thus preventing contact with the product, so product quality is not compromised, according to the company. For maximum effect, the desiccant bags are mounted in varying places on the liner.
  
  A range of the company's line of Emprove pharmaceutical raw materials is available in the Drypour packaging system. The Drypour system is available in 100-kilogram package sizes and can be moved with common handling devices. The system meets both European Pharmacopoeia and USP requirements.
  
Source:  

EMD Millipore's new Drypour packaging system helps minimize caking of pharmaceutical raw materials.

EMD Millipore Introduces Drypour Packaging System

Puerto Rico Industrial Development Company

 and governor Alejandro García Padilla had an inauguration ceremony for Neolpharma's new Development and Innovation Center (CEDIPROF) for pharmaceutical products in Puerto Rico.

In 2013, Neolpharma  invested over $12 million in machinery and equipment in the center in Puerto Rico. The center will create 23 new jobs. CEDIPROF includes a 2000 ft

 pilot facility for research, development, and evaluation of new pharmaceutical products, as well as an analytic and forensic laboratory and a 4000 ft

Neolpharma opens its new Development and Innovation Center (CEDIPROF) for pharmaceutical products in Puerto Rico.

Puerto Rico Opens Research and Development Center for Pharmaceutical Products

Werum Software & Systems has expanded its PAS-X content packages with PAS-X MBR Design Elements content packages. The PAS-X MBR Design Elements Content Packages accelerate the creation of master batch records (MBRs) and help to assure higher quality MBR design in the configured system. The MBR Design Elements are templates for the creation of MBRs for specific processes in pharmaceutical and biopharmaceutical production such as granulation, IPC testing, or reconciliation. The Design Elements focus on the most efficient use of PAS-X functionality MBR, and are designed to operate with with PAS-X manufacturing execution system software. They are part of specific libraries available for all major manufacturing types, such as solids, liquids, and packaging. In addition, Uiversal Elements cover general processes that are not related to specific manufacturing types. The content packages provide a framework for standardizing processes within or between different plants.



Content Packages Accelerate MBR Creation

FactoryTalk information software from Rockwell Automation can help ease deployment and integration into manufacturers’ operations. FactoryTalk VantagePoint EMI Software is the central reporting and analytics product for all the products in the FactoryTalk information software suite. The VantagePoint Energy bundle includes FactoryTalk VantagePoint EMI software plus energy-specific models, charts, trends, dashboards, and analysis tools. The software delivers information regarding energy relative to a company’s production systems. FactoryTalk Metrics Software monitors equipment on the plant floor and provides efficiency monitoring, event collection, and data analysis to plant operators who need KPIs regarding machine, line, and plant performance. The FactoryTalk Historian Site Edition application collects, stores, analyzes, and visualizes production data using data capture and storage engines that can be used in process, discrete, and hybrid environments. 



FactoryTalk Software Increases Flexibility

BellHawk Systems’ 21 CFR Part 11 compliance module enables the use of the BellHawk inventory and work-in-process tracking software in manufacturing and distribution applications that need to comply with FDA GMP. The complete CFR 21 Part 11 compliant inventory and work-in-process tracking system is available for a monthy fee per management user or shared barcode scanning device. This software can be installed on a Windows server at the client’s facility or used at a secure data center. BellHawk makes use of barcode scanning and wireless mobile computers to track materials from receiving, through quality assurance, to production processing, to shipment to the end customer. It can handle formulas and batch records and builds a complete traceability history enabling one-step-back, one-step-forward tracking of the source of defects and the disposition of the resultant defective products.

