Pharmaceutical Technology Editors

Pioneering system provides induction sealing integrity analysis for 100% of bottles without packaging line slowdown.

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.

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.

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

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.

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

Teva announces the exclusive launch of its generic equivalent of Actonel in the US.

ProMetic Life Sciences will use manufacturing and plasma fractionation processes at Emergent BioSolutions’ Winnipeg, Canada facility.

The IPEC-Americas Foundation is accepting applications for graduate student, research, and industry research achievement awards.

Clinical supplies facility in Frankfurt, Germany will triple Theorem Clinical Research’s current clinical supplies capacity.

Excipient manufacturing site achieves EXCiPACT certification following regulatory inspections.

Grand River Aseptic Manufacturing named one of Michigan 50 Companies to watch.

The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or biopolar I disorder.

New guidance complements ICH guidelines on impurities.