Manufacturing

Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.

Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.

Webinar Date/Time: Tuesday, April 4th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Actylis new 30,000-ft² API manufacturing facility is located in Eugene, Ore.

Webinar Date/Time: Thu, Apr 6, 2023 11:00 AM EDT

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

PAT is crucial to process control and real-time release in continuous manufacturing of solid-dosage drugs.

Shifts in pharmaceutical packaging have spurred tremendous growth in the pre-filled syringe fill/finish industry.

Stockpiling excess inventory is no longer enough to respond to supply chain volatility.

Technological advances will help ease pressure on pharma supply chains, allowing for greater visibility and less uncertainty.

The trends shaping the growth of the biologics outsourcing industry demand attention.

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

The ROSS PDDM Planetary Dual Disperser offers flexibility in the form of removable disperser shafts.

Fluid Air’s Enhanced Magnaflo filter blowback system is designed to increase powder yield in PolarDry Models 001 and 004.

The IsoPick from iotaSciences is designed to expand handling solutions for cell biology and gene therapy applications.

Charles River’s HCP-ELISA kit is designed to increase the efficiency and efficacy of HCP assay development.

Key challenges posed to autologous and allogeneic treatments could be resolved by in-vivo CAR-T gene therapies.

AbbVie and Capsida have expanded their existing collaboration to advance three new gene therapy programs.

GAO calls for more oversight of institutional review boards in clinical trials.

Agilent’s therapeutic nucleic acids facility gains architectural design support from CRB.

Webinar Date/Time: Thu, Mar 23, 2023 11:00 AM EDT

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.

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.

Webinar Date/Time: Wed, Mar 1, 2023 11:00 AM EST

The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.