Manufacturing, Fill/Finish

Protecting against microbiological contaminationover the whole manufacturing process grows increasingly important.

An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.

Ajinomoto Althea’s Optima VFVM 7000 aseptic fill/finish line supports a range of drug substance APIs.

Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.

A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.

The companies are partnering to provide new fill/finish facilities and solutions for biopharmaceutical products.

Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.

The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

Tony Pidgeon, process technology director at Patheon discusses challenges associated with and recent innovations in the fill/finish process for biopharmaceuticals.

The ready-to-fill packaging solutions for vials are based on Ompi EZ-fill packaging design.

The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.

The company expanded fill/finish services at its facility in Kalamazoo, Michigan.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

Excipient selection strongly influences lyophilization performance for biologic drugs.

PMMI, The Association for Packaging and Processing Technologies, released a report on trends opportunities in packaging of pharmaceuticals and medical devices that predicts increased spending on capital equipment for processing and packaging.

IDT Biologika will provide fill/finish services of live-vectored virus products in clinical development through licensure.

Prefilled syringes for commercial supply of the etanercept biosimilar will be produced at Catalent’s Brussels facility in Belgium.

PaizaBio will add aseptic injectable production capacity in Hangzhou, China.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.

This key bioprocessing segment is expecting continued growth.

Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?

A company’s fill/finish individual facilities can be negatively impacted by a region’s economic climate, as currently observed at some of the pharmaceutical manufacturing locations in Puerto Rico.

Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.

CPhI Pharma Awards seek nominations for excellence in biopharma development and manufacturing.

Material compatibility, material sourcing, facility layout, and training are crucial aspects of a successful disposable fill-finish system.