Parenterals and Injectables

A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.

Pre-sterilized, nested syringes and vials are seeing increased use in sterile filling.

GSK Australia's Boronia site will install next-generation blow-fill-seal machinery for aseptic filling.

Grand River Aseptic Manufacturing has announced that the company executed two commercial production contracts in one day.

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

PDA will publish a technical report on quality risk management aspects of drug shortages in early 2015.

PDA surveys are designed to evaluate quality metrics practices at member organizations.

Innovative therapeutic approaches beyond mAbs will require new methods for future facility construction.

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

Nitrogen dioxide can sterilize and depyrogenate an aseptic fill area in a blow-fill-seal process.

New advanced aseptic manufacturing technologies are available for filling liquid pharmaceuticals, including biologics.

Funding boosts life-sciences manufacturing in West Michigan.

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

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

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

Dalton Pharma completes its $2.5 million expansion in Toronto for sterile and aseptic filling capabilities.

PDA works with FDA to create pharmaceutical quality metrics.

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

Aesica expands aseptic capabilities at its Nottingham, UK site with the acquisition of new pre-filled syringes manufacturing equipment.

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

Susan Schniepp, vice-president of quality and regulatory affairs at Allergy Laboratories and co-chair of the program planning committee for the 2013 PDA/FDA Joint Regulatory Conference, discusses quality systems and related considerations in parenteral drug manufacturing.

New cartridges designed specifically for use on high-speed filling lines increase efficiency.

Report outlines recommended practices for control and evaluation of operations.

A screening method aligned with USP 1660 guidance predicts glass delamination in primary packaging for parenterals.

Understanding the supply-chain challenge and coupling high-efficiency chromatographic techniques with information-rich detectors are leading to improvements in the management of extractables and leachables in parenteral drugs.

The benefits of single-use systems are being realized for downstream unit operations, including aseptic filling.

A screening method predicts delamination in primary packaging.

Aseptic connectors provide the flexibility and robustness needed for modern parenteral manufacturing operations.

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

Adoption of single-use systems and more flexible systems drive innovation.