Pharmaceutical Technology-01-02-2016

January 02, 2016

Parenteral packaging of the future will include more automated lines, ready-to-fill packaging formats, and supply-chain transparency.

January 02, 2016

The bio/pharmaceutical industry will face increased scrutiny of product quality and cost drivers.

January 02, 2016

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.

January 02, 2016

Appropriate use of sound science applied at critical junctures will improve efficiency in the high-wire act of drug development.

January 02, 2016

The author discusses the collection and evaluation of data part of FDA’s definition of process validation.

January 02, 2016

DAVID LEAHY/GETTY IMAGESThe pharmaceutical industry has an important role to play in implementing solutions to global envi

January 02, 2016

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.

January 02, 2016

The revised USP Chapter 1207 gives best practices for obtaining reliable data in container closure integrity testing.

January 02, 2016

Industry experts discuss what the outsourcing market holds for 2016.

January 02, 2016

Infrastructure and payer decisions will determine drug choices in emerging and developed regions.

January 02, 2016

Nanoscale catalysts and engineered nanoparticles may have a big impact on small-molecule pharmaceuticals.

January 02, 2016

Amid corporate restructurings, regulatory initiatives, and aging R&D assets, will drug development accelerate or stall in 2016?

January 02, 2016

FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.

January 02, 2016

Regulatory, corporate restructuring, and manufacturing issues will challenge bio/pharma to meet the needs and expectations of patients around the world.

January 02, 2016

Click the title above to open the Pharmaceutical Technology January 2016 issue in an interactive PDF format.

January 01, 2016

Leading nations are backing moves to strengthen WHO’s central role in international health security following the Ebola crisis, which sparked criticisms on the organization’s ability to address a pandemic outbreak.

January 01, 2016

Liquid formulations in hard-shell capsules or softgels are becoming a popular option for HPAPIs because of advantages such as improved safety and lower risk of potential exposure and product cross contamination.

January 01, 2016

The Prominence-i LC-2030 LT is a new model of Shimadzu’s i-Series integrated high-performance liquid chromatograph and ultra high-performance liquid chromatograph systems.

January 01, 2016

The Ross AMK Kneader Extruder combines the technologies of a double-arm mixer with an extrusion screw.

January 01, 2016

The BioClamp Plastic Tri-Clamp, from BioPure Technology, part of the Watson-Marlow Fluid Technology Group, is a patented plastic union tri-clamp meant to reduce distortion on polymeric fittings when subjected to heat.

January 01, 2016

The DF30Plus, a new version of Aptar Pharma’s aerosol metering valve for pressurized metered dose inhalers (pMDIs), incorporates an elastomeric cyclic-olefin-copolymer (COC) neck gasket.

January 01, 2016

Traceability and transparency will remain elusive if manufacturers continue to approach serialization projects on a case-by-case basis.

January 01, 2016

Synthetic biology promises to drive tomorrow’s therapies, while continuous processing is already being used in some new drugs.

December 02, 2015

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.