Manufacturing

In legacy facilities and as buildings age, ensuring cGMP compliance can become complex. A review of a facility's gowning operations can bring insight into the current state of cGMP compliance. The author presents characteristics to look for and questions to ask.

Experimental work on wet granulation demonstrates the use of dynamic powder characterization to support continuous processing for tablet manufacturing.

Bioreactor for Mammalian Cell Culture

Gowning practices embody cGMPs and can be a tool to evaluate cGMP compliance.

Progress in equipment availability, process analytical technology, and advanced process control aids ongoing development of continuous solid-dosage manufacturing processes.

Printing, labeling, aggregation, and inspection equipment meets serialization requirements.

Players across the biologics value chain are attracted by the advantages of continuous biopharmaceutical manufacturing.

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

Challenges encountered when implementing a continuous monitoring system are reviewed.

sterilization approach-cycles controlled by differential pressure-is described.

What is a modular system and how are modular systems being used in the biopharmaceutical industry? Pär

The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.

Application of single-use technology in a parenteral facility for syringe filling.

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

Garvey's vial-drying system and pressure-less accumulator reduces drying time and decreases the risk of vial damage.

Catalent's Advasept platform uses blow-fill-seal technology to aseptically manufacture, fill, and seal a polymeric primary container for injectable drugs.

MG America's ACE-BT300 Coding and Verification Unit provides track-and-trace capabilities for bottles.

The FXS Combi from Bosch Packaging Technology features an integrated capping station for vials and cartridges.

The Press Out Universal Mini from Sepha can deblister at a speed of up to 15 packs per minute.

The ionHP biodecontamination hydrogen peroxide-based sterilization technology is designed for use in aseptic enclosures.

The Manesty TPR 500 tablet press from Bosch Packaging Technology increases output and features a hygienic design.

New identifiers and tracking requirements aim to block illegitimate products.

Common challenges and key considerations when developing a freeze-drying cycle for protein pharmaceuticals.

USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.

Pharmaceutical Technology spoke with Gloria Gadea-Lopez, associate director of Shire, and Martin Dittmer, PharmaSuite product manager at Rockwell Automation, about how manufacturing execution systems (MES) can improve productivity and the current challenges faced by companies implementing MES systems.

New formulations and expanded vaccine production are encouraged.

Gallus BioPharmaceuticals enters a cell line optimization and manufacturing agreement with Omni Bio Pharmaceutical.

TAP Biosystems announced that Gallus BioPharmaceuticals is using its ambr15 micro bioreactor system to optimize process development and clone selection of novel antibody therapeutics and biosimilars.

CPhI report warns industry must actively drive process improvements to meet growing global demand for pharmaceuticals.

The cleaning validation lifecycle includes assessment, development, validation, and monitoring.