Manufacturing

By eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.

In the all-too-common debate over building lab facilities versus outsourcing, the best strategy may be the middle ground: licensing.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

Through collaboration and transparency, engineering and automation companies can achieve great efficiencies and success for their customer by integrating intelligent design into a facility.

By taking a digital maturity-first approach to Pharma 4.0, manufacturers can optimally position themselves for success.

Leveraging smart technology and SMEs for significant operational and financial benefits.

The new facility will allow ReiThera to consolidate its competitive position as a leading CDMO specialized in viral vector production.

Avantor is continuing its investment to support the biopharma market with the opening of its new distribution center in Dublin, Ireland.

The new Massachusetts facility will strengthen Cytiva’s cell culture services.

Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.

Gerresheimer and Nelson Labs will work together to conduct extractables and leachables testing on upcoming primary packaging solutions.

Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.

Pharma companies set goals and adopt more sustainable alternatives.

Learning from early market failures, the biopharma industry has worked to improve the fate of antibody drug conjugates.

In this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.

Various advances in contamination control are being utilized to reduce the chance pollutants contaminate a drug product.

The newly formed partnership between CSafe and BioLife will expand cold chain supply chain solutions for the cell and gene therapy market.

Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.

Aragen’s new 12,000 ft² facility will include various dosage form capabilities, including oral solids, liquids, topicals, and films.

Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.

Integrated project delivery can fast-track delivery targets by eliminating the waste involved in traditional approaches to project set-up and execution.

Using a predictive modeling approach can help tighten up operator control over bioprocessing, which in turn can increase bioreactor output.

Cytiva’s acquisition of CEVEC Pharmaceuticals strengthens the company’s cell line development and biomanufacturing capabilities.

Freudenberg Medical’s Heflix TPE tubing is a high purity TPE intended for bioprocessing applications.

Both demand for and investment in fill/finish capacity continue to rise.

The industry revisits the pros and cons of microbial fermentation at scale for biotherapeutics.

BFS technology can help maintain sterility during the biologics manufacturing process.

A simplified downstream process can save time and costs but requires enabling technologies.

Technological developments in real-time supply chain operations provide biologics manufacturers with capabilities that go beyond supply chain visibility to tangibly address security and quality challenges.