Manufacturing

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.

Non-destructive surface area measurement can improve stability testing.

Flexicon’s new range of stainless steel connection boxes are suited for applications requiring high levels of hygiene and ingress protection.

A new Low-Profile, Flo-Thru Sanitary Screener from Kason scalps oversize particles and foreign matter from dry bulk materials and solids-laden slurries at high rates in low headroom areas.

Ross, Charles & Son added a custom 150-gallon Triple Shaft Mixer, the Ross VersaMix Model VMC-150, with elaborate automation and safety functions.

Preventing problems in implementing a manufacturing execution system requires upfront analysis and detailed planning.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

Romaco Siebler and Huhtamaki will premiere a push-through strip packaging for pharmaceuticals at CPhI WorldWide 2018.

Specialist biopharmaceutical company, Alvotech, has announced receipt of a manufacturing license from the Icelandic Medicines Agency, applying to its biopharmaceutical facility based in Reykjavik, Iceland.

A collaboration using Pall’s bioprocessing technology in G-CON’s PODs enables flexible continuous bioprocessing and viral vector facility solutions.

While food, shelter, and clothing are the primal essentials for life, hope-as embodied by modern medicine-has now become part of that human expectation.

GE Healthcare, Cobra Biologics, and the Centre for Process Innovation (CPI) have entered into a collaboration to advance manufacturing of adeno-associated virus vectors for gene therapy.

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

The World Packaging Organization will present a keynote session at CPhI discussing trends affecting pharmaceutical packaging, including user-friendly design.

Nanjing-based PharmaBlock Sciences acquired a GMP-compliant manufacturing facility in Shangyu, China from Porton Pharma Solutions.

Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products.

A keynote session at CPhI will discuss how the trend to personalized medicine affects pharmaceutical packaging.

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

The biopharmaceutical company will invest approximately $800 million to expand facilities and manufacturing capacity at its campus in Rensselaer County, NY.

3D printing is being explored as a manufacturing method for on-demand, personalized medicine.

Insulated shippers boost recyclable and renewable content.

Colin Clarke, from the National Institute for Bioprocessing Research and Training, will lead a four-year project for enhancing upstream biopharmaceutical manufacturing process development through single cell analysis.

The $425-million acquisition adds formulation development and finished dosage manufacturing capabilities to Cambrex’s existing global API manufacturing network.

The provider of plant-based ingredients will present recently launched multi-compendial materials for upstream and downstream biopharmaceutical applications.

Avara Pharmaceutical Services acquired Sandoz’s sterile manufacturing facility for injectable medicines in Boucherville, Quebec, Canada.

Coperion’s ZSK 18 MEGAlab extruder fulfills requirements for both wet extrusion and hot-melt extrusion pharmaceutical processes.

At CPhI World-Wide 2018, Bosch will display its Xelum R&D for laboratory-scale continuous OSD production and its new data-mining service for equipment and process troubleshooting.

August Faller will demonstrate boxes for expanded communication space, smart packaging, and tamper-evident labels.