News

Bosch’s market launches at the show include a new bioreactor for laboratory-scale API development, a water-for-injection unit, and a new generation of pure steam generators with high yields.

Products on display include the newest addition to the Mobius line of single-use bioreactors; Cellvento CHO cell culture media for optimized production of specific cell lines; and new high-volume AFS water purification systems.

Porvair has developed a 2-ml 96 round-well deep-well plate that enables scientists to use the full 2.00 ml well capacity.

PSL has developed a dispensary isolator with a contained drum hoist mechanism for highly potent API production.

Saint-Gobain Seals is featuring several sealing and polymer solutions at ACHEMA including the OmniSeal spring-energized seals for liquid chromatography and the Rulon wear components for pharmaceutical manufacturing equipment.

GEA will showcase the ConsiGma continuous coater and the PCMM (portable, continuous, miniature, and modular) manufacturing technology platform for continuous production of oral solid dosage forms.

Technologies for serialization and aseptic packaging are being displayed at the show.

Telstar has developed an innovative in-line vial management system for recognition and marshaling of vials in automatic loading and unloading systems.

The Green Cross facility in Canada will produce intravenous immunoglobulin and albumin.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”

Machine manufacturer IMA is showcasing a number of technological advances for the processing and packaging of pharmaceutical products at ACHEMA 2015.

The Hapa 862, from Hapa AG, is a modular, CMYK/spot-color inkjet printing system for the in-line packaging printing of foils and labels.

Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

AmpliPhi announces that its new facility in Slovenia has received cGMP certification to manufacture bacteriophages for clinical trials.

CPhI Pharma Insights’ Turkey Market Report reveals, the growth and strategic plans for the future of the pharmaceutical industry in Turkey.

The pediatric investigation plan provides a clinical development plan for Viaskin Peanut in pediatric population. DBV Technologies will now be able to submit a marketing authorization application in Europe following completion of the Viaskin Peanut Phase III trials.

The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Baxter announces that it will partner with Mayo Clinic and Velocity Pharmaceutical to form Vitesse Biologics, a Baxalta-managed company focused on immunology, hematology, and oncology.

BIO announces that for the second year in a row, it will feature the Innovation Zone at its 2015 conference in Philadelphia, PA.

A new demonstration facility in New York gives Sartorius’ customers hands-on access to bioprocessing systems and lab instruments.

The pharmaceutical industry wants to speed up the variations process by eliminating redundant assessment by different national agencies in the European Union.

Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.

Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.

Will biosimilars share a compendial identity like generic drugs do?

Peer-reviewed papers and technical articles can help advance bio/pharmaceutical development.

The directorate highlights achievements accomplished during the year of its 50th anniversary.

EMD Millipore debuts a new cell-culture media compacting technology that will turn messy, dry powders into granules.