Manufacturing

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

Biosimilars and biobetters face developmental challenges to achieving commercialization.

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

Silicone is one of the polymeric materials that can be used for single-use components and assemblies in biopharmaceutical manufacturing.

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

Robust materials management, supplier quality management, quality control, and business continuity planning are essential to ensure continuous supply of single-use bags.

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

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

WuXi Biologics will invest $60 Million to establish a biologics production facility in Massachusetts.

Siemens will become a preferred supplier for Sartorius Stedim Biotech’s automation solutions, and SSB will create a globally standardized automation platform for its biopharmaceutical manufacturing systems.

ABB’s modeling software, Shop Floor Integration V2.0, allows engineers to validate the connection of existing pharmaceutical manufacturing equipment with Werum’s PAS-X manufacturing execution system in a simulation prior to running it live.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.

FUJIFILM Diosynth Biotechnologies opens Cambridge, MA center to promote collaboration with biotech companies.

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

Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.

Logistics manufacturers are adapting to explosive growth in the use of direct-to-patient clinical trials. Michael Sweeney, director of patient-centric logistics at World Courier Group, discusses the new model’s impact.

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.