Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

Kansas State University plans to build the 

Kansas State University Bulk Solids Innovation Center 

in Salina, Kansas, for companies that design and use systems for bulk solids. The center will be used to study and increase the understanding of bulk solids materials handling.

Primary partners in the projected $3.5-million, 13,000 ft

 facility are Kansas State University, the Salina Chamber of Commerce, the Salina Economic Development Corporation, and several private companies. The university will be the key tenant in the center with various offices and research suites for permanent and visiting researchers, companies, and other users. Two local companies, K-Tron and Vortex Valves, will be initial anchor tenants and will conduct both their own research as well as collaborative research with the university. 

The building will include open and enclosed laboratory areas to allow for collaborative and proprietary research projects. The open area will also allow for the more exploratory/open-access research conducted by university investigators and students. The center will incorporate Kansas State faculty from the technology, engineering, and agriculture programs. It will focus on the process industries of plastics, foods and chemicals and will complement the College of Agriculture's Bulk Solids and Particle Technology Lab and program housed on the university's Manhattan, Kansas campus. The project will use public and private sector resources, including a $1-million-plus grant through the Economic Development Assistance Programs of the US Department of Commerce's Economic Development Administration. 

Articles

Kansas State University to build Bulk Solids Innovation Center in Salina, Kansas.

Kansas State University to Build Bulk Solids Innovation Center

 (USP) posted for public comment on its recommended revisions to the USP Medicare Model Guidelines, a listing of categories and classes of medicines that Medicare Part D plan sponsors can use when developing their Part D formularies. USP is seeking public input to its revisions, which are posted for a 30-day public comment period, that began Oct. 1, 2013.

Under the Medicare Prescription Drug Improvement and Modernization Act of 2003, USP was charged with developing the Medicare Model Guidelines, which are periodically revised by request of the Centers for Medicare & Medicaid Services (CMS). In March 2013, USP received a request from CMS to conduct a clinically based review of Part D drugs approved since version 5.0 and to update the USP Medicare Model Guidelines to accommodate changes in therapeutic uses and the additions of new Part D drugs.

The draft USP Medicare Model Guidelines v6.0 comprises 50 categories and 154 classes, which include nine new class designations. The increased number of classes represents a greater breadth of medicines approved by FDA and potentially covered by Part D plans.

In addition to accepting written public comments via its website, USP will conduct Open Microphone Web Meetings to solicit specific feedback on the content and organization of the draft guidelines from beneficiaries, drug plans, pharmaceutical manufacturers, and providers. These will be held on Oct. 21, 22, 24, and 25.

The USP Therapeutic Information and Formulary Support Expert Committee is responsible for developing and drafting the USP Medicare Model Guidelines v6.0 as well as reviewing input received during the public-comment period. The final USP Medicare Model Guidelines v6.0 will undergo approval in mid-December 2013 and will be presented to CMS in early January 2014.  The USP Medicare Model Guidelines v6.0 will be available for use by prescription drug plans for the plan years 2015-2017.

The US Pharmacopeial Convention posted for public comments on its revisions to the USP Medicare Model Guidelines, which are posted for a 30-day public comment period, beginning Oct. 1, 2013.

Public Opinion Sought on USP Medicare Model Guidelines

 has renewed its manufacturing license from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The license authorizes commercial manufacturing at the company’s Billingham, UK site, and was received with zero critical or major observations.

The inspection included the company’s new cGMP mammalian cell culture manufacturing facility, which is on schedule for imminent commissioning. This facility, which will primarily utilize single-use technologies, has been designed with input from regulatory authorities, in particular the MHRA. It will initially offer 200 L and 1000 L single-use bioreactors, with 2000 L bioreactors already planned for 2014. The company announced that the cGMP Cell Banking Facility, which forms part of the larger plant, was fully commissioned in April 2013, and has already processed its first cell banks.

The license also covers commercial manufacturing of microbial-based biologics in the company’s large scale manufacturing assets. The company currently has FDA-approval for manufacture of two commercial products in these facilities.

Fujifilm Diosynth Biotechnologies has renewed its manufacturing license from the UK's MHRA.

Fujifilm Diosynth Biotechnologies Renews MHRA Manufacturing License

RheocalcT Software allows the operator to automate viscosity testing from a PC when using the DV3T Touch Screen Rheometer and the DV2T Touch Screen Viscometer. The user interface for RheocalcT has a range of choices for test method creation and data gathering/analysis.  Loop functions allow performance of repetitive tasks on test samples that require viscosity measurement at multiple rotational speeds, different temperature set points, and discreet time intervals.  Viscosity data averaging is possible for individual tasks within a test step or over multiple steps in the total test program.  Advanced data analysis to assess yield stress and pseudo plastic index can be performed with a choice of math models: Bingham, Casson, NCA/CMA Casson, Power Law, IPC Paste, and Herschel-Bulkley.

RheocalcT Software Tests Parameters and Data Collection

Dissolution Workstation Software provides updated data integration, method change control, and instrument monitoring for controlling multiple dissolution systems. The software supports laboratory capabilities to build, edit, search, retrieve, execute, and archive all dissolution methods and test reports from a single interface. The software consolidates and maintains electronic data in one location, with options for exporting information into a laboratory information management system or into business tools such as SAP Crystal Reports or Microsoft Excel. Dissolution Workstation Software organizes, executes, and manages methods and information for all Agilent dissolution equipment, including the Agilent 708-DS, 709-DS, BIO-DIS, Apparatus 7, and dissolution sampling systems.

Software Improves Monitoring of Pharmaceutical Ingredients

 introduces the Rugged Comfort Half Facepiece Reusable Respirator 6500 Series for harsh working environments. The Rugged Comfort 6500 Series helps protect workers from harmful substances with a firm silicone faceseal that holds up in high-heat environments and comes equipped with polyester-spandex straps. The Rugged Comfort 6500 Respirator Series includes a valve cover design that directs exhaled breath and moisture downward to reduce fogging and an advanced half facepiece design for a wide field of view.

3M introduces a rugged comfort respirator for harsh working environments.