Manufacturing, Parenterals and Injectables

CDMO iBio introduced cGMP sterile fill/finish services at its facility in Texas.

Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.

Wearable and smart devices allow user-friendly subcutaneous drug delivery.

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

Empty and prefilled syringes must pass a range of quality control tests.

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

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.