Manufacturing

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.

A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

The Natoli AIM Data Acquisition and Analytical Software for Natoli’s NP-RD10A single-station tablet press speeds research and development.

Machine vision and optical character recognition technologies enhance inspection of packages and labels.

GlobalData reports the need to shift away from egg-based manufacturing of vaccines in light of influenza-related deaths.

Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.

With minimal damage to its manufacturing plant in Humacao, Puerto Rico, Colorcon has been able to restore full operations.

Grand River Aseptic Manufacturing announces first planned investment in capacity expansion.

In selling its contrast media business, Hovione will focus on API and drug product development and manufacturing.

This article presents considerations for preventing hazards associated with dust in pharmaceutical production, particularly as relates to the United Kingdom's Control of Substances Hazardous to Health (COSHH) Regulations.

Twenty-first century drug development challenges sponsors and contract partners to collaborate more closely, using tools such as model-based simulation.

JLL, a real estate and investment management firm, recently released a new report on three trends shaping labs for the future of life sciences R&D.

The company showcased various updated and new analytical systems and solutions for food analysis and pharmaceutical, clinical research, and materials sciences applications.

Ross, Charles & Son has added a 500-gallon option to its line of VersaMix multi-shaft mixers.

The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks.

Catalent completes $4.6 million expansion at Singapore clinical supply facility and marks 20 years in the region.

Endress+Hauser's Memosens COS81D hygienic optical sensor can measure dissolved oxygen in pharmaceutical fermenters and bioreactors.

The ZSE 50 MAXX twin screw extruder system from Leistritz Extrusion is suited for a range of compounding tasks.

Alan Kennedy, executive director of TEAM UP, shared perspectives on Poseidon and ocean transport with Pharmaceutical Technology.

Lower costs, fewer opportunities for temperature excursions, and a smaller carbon footprint are making ocean transport more attractive for pharmaceuticals. Poseidon, a new collaborative pharma initiative, seeks to leverage benefits.

Stability testing on APIs/finished drug product helps define optimal drug packaging for shelf-life storage.

Johnson Matthey has manufactured a new Gusev catalyst for ester hydrogenation using technology that promotes sustainability and improved reactivity and selectivity, according to the company.

Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.

The authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.