Manufacturing

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

Flow indicators maximize the view into sterile processes.

Bosch Packaging Technology's RAN 3080 exterior washing machine removes product residue and other contamination from filled and closed glass containers using a new, efficient, high-pressure cleaning process.

Innovations for tablet tooling and presses improve quality and productivity.

Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.

Pall’s acquisition of BioSMB from Tarpon Biosystems expands its downstream continuous processing offerings.

Catalent acquires Pharmapak Technologies, a pharmaceutical packaging company based in New South Wales, Australia.

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

Industry awaits the final revision of USP General Chapter and the impact it will have on the evaluation of sterile product package integrity.

Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.

Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.

In-silico design facilitates process optimization and evaluation of process control strategies.

A drug-product manufacturing classification system (MCS) for oral solid-dosage forms is proposed by an Academy of Pharmaceutical Sciences working group.

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.

Multivariate data analysis (MVDA) is being used to effectively handle complex datasets generated by process analytical technology (PAT) in biopharmaceutical process development and manufacturing.

Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.

Xcellience receives approval to handle both analytical and manufacturing of DEA Scheduled products.

Drug makers back alternative to FDA labeling update rule.

Small- to medium-sized companies are expected to drive near-term growth of the global biomanufacturing outsourcing market.

Temperature-controlled packaging trends include prequalified systems that simplify adoption, reusable systems that are more sustainable, and new temperature-monitoring technology.

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

FDA has concluded that Kemwell’s facility, systems, and practices comply with FDA’s requirements and no observations were reported on Form 483.

Genentech plans to invest more than $125 million in an expansion of its fill/finish facility in Hillsboro, OR.

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.