Manufacturing, Parenterals and Injectables

The company will supply its heparin sodium injection in prefilled syringe form.

Equipment and systems for aseptic transfer and manufacture meet cGMP and Annex 1 requirements for pharmaceutical fill and finish.

The companies will work together to produce enFuse, a patient-administered subcutaneous delivery device.

Formulators of parenteral drugs must be cautious of specific considerations and challenges that arise during development and manufacture.

Hikma will supply 14 essential medicines to US hospitals and patients.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

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

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.

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.

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.

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

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.

Telstar has a dedicated process analytical technology (PAT) corner at its booth to display new developments for pharmaceutical freeze drying systems and aseptic manufacturing processes.

The companies will partner to develop smart connected monitoring and support solutions for injectable drugs.

Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.