Manufacturing

The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements.

Emmes’ new facility is designed to support clients conducting cell and gene therapy research worldwide.

Thermo Fisher Scientific’s new facility in Hangzhou, China, is designed to boost biologics and sterile development and manufacturing capabilities in the Asia-Pacific region.

Through the integration of human expertise, artificial intelligence, and automation robotics, bio/pharma companies can more efficiently target drug discovery efforts with bigger payoff.

Manufacturing biopharmaceuticals in an aging facility may create quality issues such as equipment breakdown and contamination risks.

The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.

Digitalization of bioprocessing is slowly bringing benefits to the biopharma industry.

mRNA may not be a train we necessarily all need to get onboard immediately, but we should know where the central train station is located, and what it connects us to.

The agreement will see Immutep and Merck KGaA, Darmstadt, Germany jointly fund the INSIGHT-005 study.

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

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.