Manufacturing

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

CDMO Vetter produces identifiable labeling for a top-ten pharmaceutical company.

IDT Biologika receives 2015 Facility of the Year Award or facility integration from ISPE.

With the Indian pharmaceutical industry on the rise, manufacturing businesses are working together with European and American partners to harness their longstanding experience and reputation in cleanroom manufacturing for a broader pharmaceutical manufacturing marketplace.

Catalent’s Zydis technology will be used to develop thermo-stable and cold-chain independent vaccines.

FlexiBulk tip packs save space and effort in the laboratory

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

Prequalified manufacturing suites could benefit from a new business model, say some industry executives.

Serialization systems can share information between manufacturing and business units, supply-chain partners, and the retail point of sale.

Ansell's HyFlex gloves made with Intercept technology yarns improve hand protection.

INTERPHEX 2015 is under way and Pharmaceutical Technology and BioPharm International are in the middle of the action!

The past six months has seen some major changes to the sterile manufacturing landscape in Europe. There have been a number of exits and acquisitions that have no doubt grabbed headlines, but has anything really changed?

With the inauguration of the Technology Center, the engineers, scientists, pharmacists, and IT developers for the first time closed the loop control circuit of a modular system along the entire process including production, sensor technology and controlling.

Serialization experts will share best practices and practical applications at INTERPHEX 2015.

Catalent completes a $52 million expansion program for advanced oral solid manufacturing solutions at its Winchester, KY, facility.

PTI's next-generation VeriPac Inspection System, the VeriPac 310, uses new vacuum-decay technology to increase leak-detection accuracy for a range of flexible and rigid packages and containers.

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.