Manufacturing, Parenterals and Injectables

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

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

Changes in the working procedures and disposable fluid flow paths resulted in a measurable decrease in product waste in a low-volume, high-value fill-finish line.

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

The Parenteral Drug Association has established a task force to develop a peer- and regulatory agency-reviewed Technical Report that will serve as a science-based industry reference document.

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

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

After realizing benefits from the adoption of a single-use filling line for one specific product, Patheon took the leap and installed a single-use filling line in a new facility.

A recent market analysis offers a promising outlook for contract fill-finish and lyophilization services.

CentuRecon enables dry formulations of therapeutic proteins to quickly be prepared for injection at high concentration.

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.

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

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

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.

Lyophilization technologies for controlled nucleation.

Optimized freeze-drying cycles can offer scientific and business advantages.

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.

PIERRE FABRE MEDICAMENT PRODUCTION has 22 years experience in isolator technology for aseptic filling of high potent freeze-dried injectable products.

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

The growth in biologics drugs and vaccines is leading to greater demand for prefilled syringes, which provide greater safety and convenience for healthcare workers and patients.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

PharmTech speaks to Ray O'Connor from the National Institute for Bioprocessing Research and Training (NIBRT) for an overview of aseptic processing.

Even when all is well at the facility, one must expect the worst while braving the elements.

Experts share insights into analytical tools and techniques.