Manufacturing, Aseptic Processing

Understanding differences in bioreactor lifecycle, design space, and product platforms is important for selecting a bioreactor type.

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.

Vetter anounced the Open Innovation Challenge to examine the applicability of digital trends to injection systems.

RGtimeline/Shutterstock.comParenteral product quality is improving.

Developments and investments in single-use systems advance upstream biomanufacturing.

The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective.

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

Ompi EZ-fill vials and Daikyo Seiko PLASCAP press-fit closures are a confirmed product set for use with Vanrx Pharmasystems' Aseptic Filling Workcells.

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.

Amgen plans to invest approximately $300 million in a new biomanufacturing plant in the United States.

The Flexicon PF7 peristaltic tabletop aseptic liquid-filling machine from Watson-Marlow Fluid Technology Group is suitable for GMP-regulated biotechnology and pharmaceutical operations.

As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.

Meissner Filtration Products has acquired PDC Aseptic Filling Systems, a supplier of aseptic filling systems and sealers, to expand Meissner's automated platform offerings.

The company will invest $139 million in sterile manufacturing technology at its facility in Ballytivnan, Sligo, Ireland to support the growth of its oncology pipeline.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

Sterile-molded filling assemblies from AdvantaPure are suited for single-use vial and syringe filling.

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

Alternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

The use of external retainers to enhance the seal between connectors and tubing is an essential component in single-use manufacturing systems.

The company is investing EUR 170 million (US$201 million) to expand its vaccine manufacturing site in France for its newest influenza vaccine.

This study outlines methods for an alternative protein-polishing process for challenging proteins.

Fresenius Kabi broke ground on a previously announced $250 million expansion of its Melrose Park, IL, manufacturing facility.

Choosing a suitable material for fill/finish containers begins during the product development stage.

The control of biologics microbiological impurities, contaminants, and mimetics is evolving.

Protecting against microbiological contaminationover the whole manufacturing process grows increasingly important.

Ajinomoto Althea’s Optima VFVM 7000 aseptic fill/finish line supports a range of drug substance APIs.

FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.