The Danish pharmaceutical group Novo Nordisk has chosen Bürkert, the fluid control specialists, to equip its latest production line for the formulation of insulin vials at its site in Chartres (Eure-et-Loir), France. A technical solution supported by Bürkert allows the pharmaceutical leader to simplify their processes and increase productivity. Read more.
Implementation of USP 232/233 limits on elemental impurities was deferred to synchronize with upcoming ICH Q3D guidelines. Although no timeline for implementation is set by USP, a recent document suggests that implementation may be soon.
Don't let the uncertainty of the implementation timeline catch you unprepared. Contact Anton Paar for more information.
Five Technology Trends That Will Impact Clinical Research
By Ed Miseta, Editor
Zikria Syed, CEO of enterprise software company NextDocs, has seen many technology advancements in life sciences, including open standards, mobile access, tablets, and cloud computing. However, despite the cost and compliance advantages offered by many of these advancements, clinical research firms are still slow in adopting them. Research conducted by his firm shows this dynamic is about to change. Read more.
Strategies For Gamma Sterilization Of Pharmaceuticals
By Ruth Garcia, Betty Howard, Rose LaRue, Glenn Parton, and John Walker, Steris Isomedix Services
A crucial step in pharmaceutical production is sterilization. There are many sterilization methods to choose from, such as steam, sterile filtration, ethylene oxide gas (EtO), electron beam (E-beam), and gamma radiation. Each technique has aspects that make it suitable or unsuitable for the sterilization of a particular product. Read more.
Modular Does Not Always Mean Flexible For Pharmaceutical Facilities
By Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing
Lately, the pharmaceutical industry has become increasingly interested in flexible facilities. There are many reasons why such facilities are needed; for example, for new drug development, or to accommodate changes in process technologies, such as the implementation of single-use process equipment. The move to personalized medicine also dictates construction of more flexible facilities. But there are also purely economic reasons for shifting from traditional to flexible facility designs, not the least of which is the need to reduce costs. Read more.
Innovative Partnership Helps Shorten The ADC Supply Chain
By Ed Miseta, Editor
Ask anyone involved with antibody drug conjugates (ADCs), and they will tell you this is an exciting time to be in the market. While there are some concerns about possible regulatory guidance that will eventually be crafted to address this relatively new market, two recent FDA approvals (Adcetris and Kadcyla), and several more products in clinical trials, has the future looking bright. Partnerships, such as the ones between Seattle Genetics and Spirogen, Celgene and Sutro Biopharma, and the acquisition of MedImmune by AstraZeneca, have been instrumental in advancing ADCs, and will continue to drive the technology going forward. Read more.
Emerging Fourth Generation Pharmaceutical Containment Technologies
By Sterling Kline, RA IPS
Barrier technology has become overwhelmingly accepted as the basis for new aseptic processing facilities in 2013. The traditional cleanroom facilities of the 20th century are being rapidly replaced with advanced barrier-based technology filling facilities. This technological evolution is dramatically reducing the risk of product contamination and risk of infection to patients. Read more.
The Schenck AccuRate PureFeed® AP-300 Feeder was designed specifically for sanitary processes that include the following customer-driven features: quick-and-easy disassembly, a dual arm agitation system for maximizing material handling versatility, and an FDA-compliant EPDM feed hopper that is disposable and recyclable. That means simpler, shorter cleaning cycles and virtually no chance of cross contamination when moving from one material to another. The PureFeed AP-300 is available in volumetric and gravimetric configurations with feed rates from 0.5 to approximately 150 Kg/hour.