Manufacturing, Parenterals and Injectables

Closed systems for aseptic fill and finish were featured at INTERPHEX 2019.

In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.

The company will open its first European manufacturing facility in Castlebar, Ireland.

The Flexicon FPC60 peristaltic fill/finish system from Watson-Marlow Fluid Technology Group can use a variety of modules that allow users to create their own customized filling solution to suit small-batch applications.

Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.

AqVida, winner of the 2018 CPhI Excellence in Pharma Award for manufacturing technology and equipment, identifies advantages of robotics compared to conventional automation in fill/finish operations.

The expansion adds new capabilities and enhances existing service offerings for both oral and parenteral dosage forms.

A London-based pharmaceutical company has been charged with offences relating to the nature and quality of medicinal product used for parenteral nutrition in babies.

Single-use technologies, modular systems, and robots are on the rise.

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.

Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.

Traditional glass and polymeric materials compete for market share in primary packaging for parenteral drug products.

The author reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including isolators, restricted access barrier systems, and split butterfly valve technology.

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

Flow imaging microscopy can be used to identify particulates and their sources.

Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.

Rommelag will showcase its single-use, flexible packaging system at Achema 2018.

Rommelag will showcase its blow-fill-seal technology that collectively offers container production, aseptic filling, and container closure.

Optima will also display the freeze dryer CS and the sterility test isolator STISO at the show.

Pharmaceutical machine concepts for large and small factories of the future need to be readily available, flexible when it comes to processing variation, and modular in design.

Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.

Innovations in fill/finish equipment and in solid-dosage moisture-control packaging technologies were on display at INTERPHEX 2018.

Choosing the right contamination control platform requires considerable research into what a product needs for an effective process design.

Ready-to-use components eliminate the need for component preparation by the drug product manufacturer, enabling them to streamline their processes and focus on their core competencies, such as drug product development and manufacturing.