Manufacturing

Rentschler Biotechnologie expands European manufacturing capabilities with GE Healthcare Life Sciences bioprocess technologies.

A core coating module allows Roeltgen's FlexiTab development and small-batch tablet press to manufacture multi-layer and externally lubricated tablets.

India may go to the World Trade Organization if the EU does not reconsider its decision to suspend the sale of about 700 generic drugs that were approved based on clinical trials by GVK Biosciences.

Innovations include multimedia packaging and improved filling systems.

Experts discuss some of the latest trends in buying and selling used pharmaceutical equipment assets.

Schreiner MediPharm's low-migration labels for plastic containers use qualified adhesive systems, materials, and inks.

The single-use clarification system eliminates centrigues; harvesting can be performed in one step; and process robustness and predictability are ensured.

3C! Packaging's Clear Code coating enhances laser-etching on pharmaceutical packaging.

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

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.