Pharmaceutical Technology-12-02-2018

December 02, 2018

Kimberly-Clark Professional added the Kimtech A5 Sterile Integrated Hood and Mask XL for head shapes, sizes, and hairstyles that pose a challenge to standard aseptic gowning for cleanroom operators.

December 02, 2018

Boehringer Ingelheim plans to develop and test new strategies at its Solids Launch facility.

December 02, 2018

Transdermal patch design, materials, and manufacturing variables, as well as drug formulation and interactions between the API and the adhesive, can affect adhesion and drug delivery.

December 02, 2018

Virpax’s Patch-in-a-Can technology delivers pain medication using a metered-dose spray film.

December 02, 2018

To improve production in pharmaceutical manufacturing, the IT, OT, and Quality functional groups must work together to get the most value from existing plant data.

December 02, 2018

Drug and adhesive formulation are crucial to the development of microneedle patches for pharmaceutical transdermal delivery systems.

December 02, 2018

A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.

December 02, 2018

Microbial identity data can be critical for determining contamination sources.

December 02, 2018

Antibody-based drugs offer new mechanisms of action and greater specificity.

December 02, 2018

Bio/pharma companies cannot spell success without solving all elements of quality programs.

December 02, 2018

Success depends on supplier communication and transparency, but it’s up to buyers to demand the right information and to look at the vendor’s overall business goals.

December 02, 2018

Simplified role-based training can lead to better quality metrics and compliance.

December 02, 2018

Once described as “throwing processes over the wall,” tech transfer is evolving into close collaboration and communication, as potential problems are considered sooner, and new technology is applied. Joseph Szczesiul, director of technical services for UPM Pharmaceuticals, shares best practices.

December 02, 2018

Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.

December 02, 2018

Taking stock on the ‘big-ticket’ news items, both good and bad, from the past 12 months.

December 02, 2018

EMA’s relocation to Amsterdam and resulting staff losses could severely weaken the agency’s role as a leading medicines regulator.

December 02, 2018

Three hypothetical analytical target profiles (ATPs) are provided, reflecting the current thinking of the the European Federation of Pharmaceutical Industries and Associations Analytical Lifecycle Management Team.

December 02, 2018

GMP non-compliance can spill over and impact patient access to life-saving medications.

December 02, 2018

CMOs and CDMOs made investments in new and expanded facilities and services in the last quarter of 2018.

December 02, 2018

A robotic tray-loading system from ESS Technologies gently handles glass prefilled syringes.

December 02, 2018

Charles Ross & Son Company recently developed two specialty customized 150-gallon double planetary mixers (Model DPM-150) with patented high viscosity blades.

December 02, 2018

Adents' DispaX offers improved supply-chain traceability for pharmaceutical warehouses, wholesalers, distributors, and dispensers such as pharmacies and hospitals.

December 02, 2018

Click the title above to open the Pharmaceutical Technology December 2018 issue in an interactive PDF format.

December 02, 2018

Using training devices may ease patient anxiety about using autoinjectors and prefilled syringes, potentially leading to improved patient adherence.

December 02, 2018

FDA Commissioner Scott Gottlieb has been promoting drug market competition in recent months that includes new guidance documents and targeted advisories to support R&D of complex drugs and combination products.

November 29, 2018

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.