Manufacturing

Alternative approaches to freeze drying are gaining popularity and will help to overcome some of the challenges associated with conventional lyophilization.

Single-use systems hold key benefits for biomanufacturers, despite certain limitations.

In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.

This new pioneering phase of mRNA is loaded with potential, but also obstacles and false dawns.

Pharmapack Europe experts expect smaller and medium European packaging companies to grow or be acquired.

Advanced LC technologies can streamline the review process for LC equipment maintenance.

Messenger RNA is inherently unstable and thus requires unique solutions to protect its cohesion.

This compilation allows readers to adjust their thinking to appreciate the full impact certain select technologies will make on the industry by 2026.

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

The testing of new convecdiff membranes shows this material to be well suited for lab- and commercial-scale bind-and-elute applications.

Efforts to optimize the ideal blend of technology and best practices that are needed to protect and deliver time- and temperature-sensitive biologic therapies, vaccines, and cell and gene therapies continue to evolve.

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.