Manufacturing, Parenterals and Injectables

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

Dalton Pharma Services completed an expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.

Recipharm is investing EUR3.7 million (approximately $4.18 million) to increase lyophilization capacity at its Masate facility in Italy.

The company manufactures biological drug products and intermediates for the allergy vaccine market.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.

Non-destructive container closure integrity testing allows 100% inspection of all ampoules, syringes, vials, and cartridges.

Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.

Parenteral packaging of the future will include more automated lines, ready-to-fill packaging formats, and supply-chain transparency.

Although shortages, quality, and regulatory challenges remain, improved technologies and new investments suggest that the worst may be over.

Miriam Beyer, European marketing manager, West Pharmaceutical Services, describes causes of recent parenteral drug shortages.

Manufacturers of parenteral drugs face challenges to increase efficiency, control particulates, control extractables and leachables, and eliminate product/package interactions; new containers and packaging equipment offer increased options.

The expansion will enable relocation of its North American headquarters from Grayslake, Illinois.

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

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

Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.

This article looks at data gathered from several studies of a widely marketed chlorobutyl rubber formulation used for vial stoppers and prefilled syringes.

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

The VERISEQ nucleation technology offers a commercially viable technique for cryogenically generating a uniform dispersion of microscopic ice crystals (or ice-fog).

Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.

While the optimization of a lyophilization cycle for a biologic relies on a well-characterized formulation, viscosity and aggregation after product reconstitution must also be carefully managed.

The parenteral manufacturing industry is taking action to address particulate contamination issues.

Representatives of contract service organizations that specialize in parenteral drug development and manufacturing describe the evolving trends.

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.

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

A new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.

Progress in delivery science, manufacturing technologies, and commercialization are playing critical roles in advancing the development of complex parenteral drug formulations for new drug substances having a variety of formulation challenges

Recipharm has invested EUR 32 million ($43 million) in its Wasserburg, Germany site to expand lyophilization capacity.