Pharmaceutical Technology-05-02-2019

Closed systems for aseptic fill and finish were featured at INTERPHEX 2019.

Contract packagers expand operations and services to accommodate growing need.

The EndonucleaseGTP ELISA Kit from Cygnus Technologies detects and quantitates residual endonuclease impurities in recombinant vaccines and viral vectors used for gene therapy.

Wabash MPI and Carver’s PNP Series is a new line of pneumatic presses for a variety of applications, including composites molding, laminating, rubber molding, plastics testing, fluid/resin extraction, destructive testing, bonding, cell disruption, and sample preparation.

Wilden added the PS2 25 mm (1-in.) model to its line of Saniflo Hygienic Series (HS) air-operated double-diaphragm (AODD) clamped metal pumps.

The Ross VMC-1000 VersaMix is a 1000-gallon triple-shaft mixer available on a pivot-design single-post hydraulic lift.

FDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.

New agency leadership is pressed to promote innovation while addressing safety and quality issues.

We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.

Pharma delivers a positive message with renewed efforts to eradicate malaria.

Particle morphology of magnesium stearate, added as an anti-caking agent in a high water‑soluble drug substance, has an influence on the dissolution rate of compressed tablets.

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.

While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and enable real-time release.

In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.

Large biopharmas, emerging biotechs, and CMOs are looking for novel ways to improve the productivity of biologics in a rapidly evolving biotherapeutics market.

This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.

Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.

Click the title above to open the Pharmaceutical Technology May 2019 issue in an interactive PDF format.

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.

Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.

A new conference is set to provide a platform for European regulatory professionals to come together to discuss relevant issues and share expertise.