Using Alternating Tangential Flow in a 3000-L perfusion bioreactor, the company expects to reduce production time by up to 30%

The acquisition strengthens BioLife’s position as a supplier of disruptive, enabling solutions used for manufacturing, storage, and distribution of cell and gene therapies.

The new facility will manufacture biopharmaceutical products under cGMP conditions.

The acquisition expands Eurofins Genomics’ gene portfolio while bolstering Blue Heron’s production capabilities.

Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling four lots of 4% lidocaine topical cream and liquid gel products due to microbiological contamination and incorrect potency.

Jack Bailey, president, US Pharmaceuticals, GlaxoSmithKline, will step down from his position at the end of 2019 and will be succeeded by a Merck KGaA executive.

The acquisition will expand BioIVT’s disease-state portfolio by volume and product range.

The new position will expand the company’s large-molecule and protein therapeutics services by partnering with biopharmaceutical clients who are navigating the large-molecule product development life cycle.

The Tridex Protein Analyzer from IDEX offers the ability to directly measure protein titer from a bioreactor in real time.

The facility will support gene therapy production and continued development of PTC’s pipeline of investigational medicines.

South Korea’s pharma/biotech space is projected to grow to $23.2 billion by 2022, and will likely attract foreign investment, according to a new market report by GlobalData.

The company has launched new services for mammalian cell bank manufacturing under GMP conditions.

The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.

The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.

An affiliate of the Permira funds has signed an agreement to purchase Cambrex in an approximately $2.4-billion transaction.

A US District Court in Washington, DC upheld FDA’s interpretation of clinical need when choosing which substances are approved to use for drug compounding.

The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.

Under an agreement, Colorcon will incorporate TruTag’s edible microtag technology in its coatings.

Fifty years after the man walked on the Moon, space-based science is benefiting Earth.

As vaccines gain prominence within pharma, there is an expectation that specialized CDMO services will provide opportunities.

Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.

The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.

Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.

To help customers succeed, CDMOs have moved away from the ‘fee-for-service’ model to offer flexible, full-service partnerships.

Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.

Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.

Instrumentation advancements over the past 30 years have certainly enabled greater efficiency in pharma development and analysis despite slow adoption by the industry.

Glass vials have come a long way from mere commodities and are now considered an integral part of final drug product.