Manufacturing, Aseptic Processing

Questions and answers about contemporary closed-system design criteria for aseptic processing equipment

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.

Catalent completes purchase of biologics fill-finish and oral solid dose facility in Anagni, Italy

US-based SP Industries acquired the sterile filling line assets of Spain-based i-Dositecno.

Gerresheimer enlarged a cleanroom, installed a high-performance furnace, and automated testing and packaging systems for pharmaceutical glass packaging in Essen, Germany.

Ireland's National Institute of Bioprocessing Research and Training (NIBRT), together with technology providers such as GE Healthcare, and universities in Ireland and around the world, are developing courses that aim to close the gap between theoretical studies and practical workplace needs.

Advances in fill/finish for parenteral packaging address demands for efficiency and product safety.

Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing.

Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

Valve design and materials affect performance and cost to maintain.

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

At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

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

Distek, a provider of laboratory testing instruments, added a dual impeller single-use bioreactor (SUB) system to its BIOne portfolio.

The Pharma Services business of Thermo Fisher Scientific will invest $150 Million at three facilities.

Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.

The US District Court for the Western District of Pennsylvania entered into a consent decree of permanent injunction against Ranier’s Rx Laboratory Inc., a compounding facility.

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

Kimberly-Clark Professional’s Kimtech A5 Sterile Boot Covers with Clean-Don Ties and Vinyl Edge provide reliable sterile protection for ISO Class 5 or higher cleanrooms.

To ensure the sterility of parenteral biopharmaceutical products, it is necessary to employ certain tools, technologies, and standard operating procedures.

The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.

Microbial identity data can be critical for determining contamination sources.

Unprocessed bulk material harvested directly from the bioreactor should be tested for contamination prior to downstream processing.

Bioconjugation requires aseptic manufacturing and containment for cytotoxic payloads.

A matrix of multi-functional cleanrooms can be adapted for launching products.

This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.

Kimberly-Clark Professional added the Kimtech A5 Sterile Integrated Hood and Mask XL for head shapes, sizes, and hairstyles that pose a challenge to standard aseptic gowning for cleanroom operators.

This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.