Manufacturing, Parenterals and Injectables

Aseptic Processing Practices: Reviewing Three Decades of Change

August 01, 2020

Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.

R+D Custom Automation Supplies Vial Machinery to SiO2 Materials Science

July 09, 2020

The agreement will accelerate production of SiO2’s plastic vials for vaccines and therapeutics for Operation Warp Speed.

COVID-19: Shoring Up the Drug Delivery Infrastructure

July 02, 2020

BioPharm International

Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines.

Grand River Aseptic Manufacturing Opens Large-Scale Injectable Fill/Finish Facility

July 02, 2020

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Risk Aversion Remains an Obstacle to Innovation in Closed Systems

May 12, 2020

Risk aversion is impeding the use of closed aseptic systems, and adding unnecessary cost and complexity to aseptic operations in the pharma industry.

Remdesivir Approved for Emergency Use

May 02, 2020

FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.

Straight Talk on Closed Aseptic Systems

May 01, 2020

BioPharm International

The industry’s aversion to risk has led to its treating closed aseptic processing systems as miniature cleanrooms, resulting in redundant and expensive practices. This article ponders this impasse, examining new technologies and applications in light of past regulatory guidance and more than 40 years of operating evidence.

FDA and EMA Accept Biologics Application for Novartis Multiple Sclerosis Cell Therapy

February 27, 2020

If approved, the therapy may become the first-choice treatment for relapsing multiple sclerosis patients and will be the first B-cell therapy that can be self-administered using an autoinjector pen.

Eli Lilly to Invest $470 Million into New Pharma Manufacturing Facility

January 27, 2020

The facility will produce parenteral products and delivery devices and is set to create 460 new jobs.

Components Enhance High Volume Injectable Drug Delivery Systems

November 21, 2019

West introduced NovaPure 3-mL Cartridge components and the SmartDose Gen. II 10-mL injector.