Sterilization Test Provide Vital Information On Pharmaceutical Packaging
How sterilization tests provide important information on pharmaceuticals, packaging and product safety. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 20, 2016 Category: Pharmaceuticals Source Type: news

Terminal Sterilization On The Safe Side
How sterilization tests provide important information on pharmaceuticals, packaging and product safety. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 20, 2016 Category: Pharmaceuticals Source Type: news

Protecting Against Contamination When Filling Cytostatic Drugs
Cytostatic agents are used to treat cancer and autoimmune diseases and are among the most complex and delicate drugs. The active ingredients consist of cell poison; highly potent substances which interfere with the growth of cancer cells and inhibit cell division. Regarding production and handling, the highest quality requirements apply. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 20, 2016 Category: Pharmaceuticals Source Type: news

Cytostatic Drugs In A Closed System
Cytostatic agents are used to treat cancer and autoimmune diseases and are among the most complex and delicate drugs. The active ingredients consist of cell poison; highly potent substances which interfere with the growth of cancer cells and inhibit cell division. Regarding production and handling, the highest quality requirements apply. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 20, 2016 Category: Pharmaceuticals Source Type: news

Why Russia Is An Atrractive Market For Clinical Trials
By Sue Lee, Technical Portfolio Manager, World Courier The largest country in the world, Russia is bigger than Pluto at 16.6million km2, and is separated from the USA by less than 4 km. Still nominally at war since 1945 with Japan over the Kuril Islands, it has 20% of the world’s unfrozen fresh water in a single lake, Lake Baikal. It spans nine time zones, has 28 official languages and has the world’s longest railway. The first Russian child to receive the vaccine against smallpox was called “Vaccinov,” given a pension, and observed throughout his life. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 20, 2016 Category: Pharmaceuticals Source Type: news

Russia – A Country In Focus
By Sue Lee, Technical Portfolio Manager, World Courier The largest country in the world, Russia is bigger than Pluto at 16.6million km2, and is separated from the USA by less than 4 km. Still nominally at war since 1945 with Japan over the Kuril Islands, it has 20% of the world’s unfrozen fresh water in a single lake, Lake Baikal. It spans nine time zones, has 28 official languages and has the world’s longest railway. The first Russian child to receive the vaccine against smallpox was called “Vaccinov,” given a pension, and observed throughout his life. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 20, 2016 Category: Pharmaceuticals Source Type: news

Avoiding Collaboration Failure In Bio Pharma: Is It Possible? With The Cloud It Is.
By Matt Hahn, Ph.D., senior VP and CTO, Dassault Systèmes BIOVIA With the drug patent cliff continuing to cast a long shadow over biopharma, the industry is radically reinventing itself by embracing globalization and focusing on innovation and operational excellence. Most importantly, biopharma organizations are expanding externalized collaborative relationships beyond traditional boundaries and creating flexible networks of researchers — some in-house, others with industry and academic partners, research institutes and contract research organizations. These networks are increasing in size and complexity with...
Source: Pharmaceutical Online News - May 20, 2016 Category: Pharmaceuticals Source Type: news

Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off
By Tim Moran, Product Manager, Life Science Research, assault Systèmes BIOVIA With biologics filling the pipelines of life sciences companies more than ever, the biopharmaceutical industry needs to rethink its view of quality. Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research. The need to focus on quality during early biologics research stems in part from the complexity of biologics, but it also results from the increased regulatory scrutiny required when working with living organisms as source materials fro...
Source: Pharmaceutical Online News - May 20, 2016 Category: Pharmaceuticals Source Type: news

Digitally Transforming Laboratory Operations
By Daniela Jansen, Ph.D., Dassault Systèmes BIOVIA “Digital transformation” is a common buzzword across industries today, but is it more than just jargon?  Faced by shifting consumer demand, rapidly evolving technology and increasing competition, organizations — to a large extent from science-based industries — are realizing that business as usual (or only incremental change to traditional approaches) does not address today’s challenges in a sustainable, long-term way. Instead, organizations are investigating and implementing disruptive business models and digital technology that ...
Source: Pharmaceutical Online News - May 20, 2016 Category: Pharmaceuticals Source Type: news

Why A One-Source-One-Location Outsourcing Model Makes Sense
Like many biopharma companies, you’ve probably concluded that outsourcing some portion of your drug development and clinical and commercial manufacturing is the best strategy for maximizing your speed to market and balancing the challenges of a growing portfolio. You already know all of the benefits of outsourcing; you just need to choose the right partners — or partner. However, with an increasing number of mergers and acquisitions, there is a capacity crunch when it comes to CDMOs. “During the last few years there has been a fair amount of mergers and acquisitions in the outsourcing space,” says ...
Source: Pharmaceutical Online News - May 20, 2016 Category: Pharmaceuticals Source Type: news

Dale Natoli Bestowed Honorary Degree - Doctor Of Science From Long Island University
Preceding the commencement ceremonies for the Long Island University Pharmacy graduating class of 2016 held on May 12 at the Arnold and Marie Schwartz College of Pharmacy and Health Sciences, was the honorary degree presentation ceremony in which Natoli Engineering’s President, Dale Natoli, was bestowed an Honorary Degree of Doctor of Science. A rare distinction in the field of Industrial Pharmacy. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 20, 2016 Category: Pharmaceuticals Source Type: news

Double Planetary Mixer Designed For Pharmaceutical Viscous Formulations
The Ross Double Planetary Mixer is ideal for single-pot mixing and deaeration of viscous formulations such as thick pastes, putties, gels and other semi-solid products. Equipped with the patented “HV” (High Viscosity) blades, the Double Planetary Mixer can process highly filled and high density applications up to 6 million centipoise in viscosity. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 19, 2016 Category: Pharmaceuticals Source Type: news

Don't Be A Daredevil When Retrofitting Your Facility
By Bob Ferer, The Ferer Group When I was a kid, I used to collect leftover pieces of wood from my father’s projects. My friends and I would build bicycle ramps used for jumping over obstacles (famed U.S. stuntman Evil Knievel was big back then). Luckily, we didn’t have iPhones and YouTube to record the outcome for all the world to view. From what I see, rigging together disparate materials to build something that fails remains a popular pastime. In our industry, there exists an expectation for a facility to be purpose-built to our specifications. At the same time, regulators are keen to ensure companies demon...
Source: Pharmaceutical Online News - May 18, 2016 Category: Pharmaceuticals Source Type: news

Missed Opportunities For Adventitious Agents Testing
By Sven M. Deutschmann, PhD, Roche Diagnostics GmbH Current adventitious agent test methods feature numerous limitations. Assays based on polymerase chain reaction (PCR) offer the potential to lift these limitations and offer better overall detection of adventitious agents. This is an area that biologics manufacturers are actively exploring, and current research indicates that PCR-based testing is not only scientifically valid but also acceptable to regulators. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 18, 2016 Category: Pharmaceuticals Source Type: news