Manufacturing

By minding gaps in industry knowledge, bio/pharma companies can avoid development pitfalls.

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

GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.

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

WuXi Biologics will build a biologics manufacturing facility in Singapore that will use both fed-batch and continuous perfusion-based single-use bioreactors.

The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.

The company has leased and purchased facilities in the United States and Europe to expand its cell therapy pipeline.

Parker Bioscience will expand laboratory, cleanroom, office, and warehouse facilities at its Birtley, UK manufacturing site.

The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.

The companies have extended a contract agreement for the commercial manufacture of the active pharmaceutical ingredient for vonapanitase, an investigational drug intended to improve hemodialysis vascular access outcomes.

InstantGMP INV is a validated software for real-time material tracking and inventory control in biopharmaceutical manufacturing.

The companies expanded their partnership to develop and commercialize messenger RNA (mRNA) cancer vaccines to include shared-antigen mRNA cancer vaccines such as mRNA-5671.

Lonza announces addition of mid-scale biologics manufacturing capacity and cell-therapy suites at Portsmouth, NH site.

GE Healthcare’s new Sefia S-2000 cell processing system allows operators to conduct multiple cell therapy manufacturing steps with one instrument.

The company will invest EUR 325 million (US$389 million) in a new biomanufacturing facility in Ireland using single-use bioreactors.

The companies will partner to develop smart connected monitoring and support solutions for injectable drugs.

Public health authorities and the biomedical research community are seeking new strategies to address global health threats.

A validation plan developed to support a process unrelated to bio- pharmaceutical manufacture is applied to bio- pharmaceutical processes and systems.

The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and downstream applications.

While technology promises advances for healthcare, a skilled workforce is needed to deliver on the potential.

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

Process understanding and careful assessment of risks are essential in developing viral clearance programs.