Manufacturing

A new GMP facility in Massachusetts will produce enzymes and other reagents for in-vitro diagnostics.

With drug development trends shifting towards personalized medicines, new technologies are needed for the manufacture of these highly sensitive drug products.

The exclusive manufacturing collaboration will establish production for adeno-associated virus gene-therapy treatments incorporating REGENXBIO’s NAV Technology.

Lyophilization Services of New England announces inspection approvals that will allow its Bedford, NH facility to begin manufacturing commercial drugs for US distribution.

Groninger has developed FlexPro 50, an isolator system for aseptic processing of nested syringes, cartridges, and vials. FlexPro 50 is capable of achieving outputs of up to 5000 containers per hour.

The increasing number of biopharmaceuticals in the development pipeline has created the need for packaging technologies with enhanced safety features, especially for sensitive biologic drugs.

Designed with safety standards in mind, flowtherm Ex incorporates a number of connectable sensors, such as vane wheel, vortex, thermal, Pt100, and other physical sensor with analog output, thereby allowing a range of applications.

The design of the shovel means that less drive power is required compared with a standard shovel, thus resulting in substantial energy savings.

Talks will explore key trends and issues in the pharmaceutical space and address the “latest industry buzz.”

Optima Pharma is exhibiting a range of technologies from sterile-filling and freeze-drying solutions to isolators and restricted access barrier systems.

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.

Hüttlin GranuLean offers a compact solution for high-quality granulation processes.

Schubert-Pharma is featuring the world's first prototype of a packaging machine without an electrical cabinet.

Domino’s G-Series thermal ink jet, D-Series laser coders, and V-series thermal transfer printers have been developed to help manufacturers comply with new global serialization and traceability legislation.

Herma’s 132M HC labelling machine is suitable for applications that require high-performance wrap-around labelling.

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.

GEA’s tableting technologies include a unique system that independently and simultaneously measures and controls both tablet weight and hardness, and a weight control system that provides increased sensitivity at lower forces.

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

This latest model is said to offer higher output and more efficient dedusting process.

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.

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.

Steve Osborn, product design manager at tablet tooling manufacturer I Holland, spoke to Pharmaceutical Technology Europe about the key considerations for successful implementation of multi-tip tooling in tableting operations.

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

Successful drug delivery via a dry powder inhaler is determined by the API physicochemical properties, the formulation composition and process, the device and operating conditions, the patient–device relationship, the environmental variables, and ultimately, patient compliance.

Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.