Parenterals

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.

New platform technologies and polymer chemistries may facilitate self-administration, longer-term delivery, and targeted delivery of parenteral drugs.

Parenteral drug delivery offers a variety of challenges but also opportunities. The author examines recent developments in nanotechnology-based drug delivery and other advances in injection-based drug delivery.

Researchers recently developed a drug-delivery system to mitigate problems associated with jet-injection drug delivery, and also improved on the design and operation of microscale actuators as a possible drug-delivery method.

Oval Medical Technologies, an autoinjector company based in Cambridge, UK, reported that a variety of highly viscous solutions have been successfully delivered through a 25-gauge thin-wall needle, in less than 7 seconds, using its innovative autoinjector. The technology provides solutions to problems in the industry for drug containment and the end user.

As an important method for improving the stability of parenterals, lyophilization is fairly well understood, but can still benefit from several advancements in the technology.

Experts describe best practices for sterility assurance in parenteral drug manufacturing. This article contains bonus online-exclusive material.

Russell Madsen, group leader of the Parenteral Drug Association (PDA) Filtration Interest Group, discusses technical and regulatory considerations in filtration for parenteral drug manufacturing