Parenterals

A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations

May 15, 2019

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.

Test Methods and Quality Control for Prefilled Syringes

May 15, 2019

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

Fresenius Kabi Launches Leucovorin Calcium Injection, USP

January 29, 2019

This injection formulation of USP-grade leucovorin calcium is now available in the United States.

London-based Pharma Company Charged with Offences Related to Baby Deaths

November 02, 2018

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.

Innovations in Prefilled Syringes for Biologic Drugs

November 02, 2018

As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.

Vetter Awards Winner of Open Innovation Challenge

September 28, 2018

Vetter chose a winner from four teams that worked for three months to develop ideas for applying digital technology to injectable pharmaceuticals.

Robotics Solve Aseptic Filling Challenges

September 01, 2018

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

E&L Risk Assessment for Biologic Drug Products

August 02, 2018

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

July 19, 2018

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.

FDA Issues Warning Letter to Baxter’s Drug Manufacturing Plant Acquired in Claris Buy

July 19, 2018

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.