Manufacturing, Fill/Finish

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

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.

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

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

The Flexicon FPC60 peristaltic fill/finish system from Watson-Marlow Fluid Technology Group can use a variety of modules that allow users to create their own customized filling solution to suit small-batch applications.

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.

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.

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

Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.

Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.

RGtimeline/Shutterstock.comParenteral product quality is improving.

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.

Grand River Aseptic Manufacturing announces first planned investment in capacity expansion.

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.

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

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 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.

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

Bormioli Rocco Pharma offers new packaging solutions for powdered oral drugs, parenteral drugs, pediatric syrups, and protein-based drugs.

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.

ABEC, an equipment and engineering company, will provide a custom-made, single-use bioreactor to custom manufacturing firm, Emergent, for its Maryland manufacturing facility.

Manufacturers introduce innovations in glass and plastic packaging for injectables.

Bormioli Rocco Pharma, an Italian supplier of glass and plastic packaging, has launched its Delta-molded, type 1 glass vials in North America.

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