Daria G. Husni

Advances in dissolution testing equipment are helping to meet user demands to a certain degree; however, more innovation in the space may be necessary for novel therapies, such as biologics.

John Bertagnolli, vice-president of Commercial Operations at Selkirk Pharma, discusses considerations when building and scaling up pharmaceutical facilities, including contamination control and aseptic processing challenges.

The drug discovery company intends for this new site to increase its reach in the region, supporting growing demands from its Asia-Pacific consumers.

EMA’s CHMP recommended treatments for hemophilia A, colorectal cancer, hypertension, overactive bladder, and metastatic breast cancer.

At CPHI NA, Rachel Harris, AstraZeneca, spoke on her work at BioPhorum to enable industry consensus and action for sustainability with drug delivery devices.

Tara Dougal, content director, Pharma, Informa Markets, discusses successes and insights from this year’s CPHI North America and the agenda for the upcoming CPHI Milan.

Purna Thakker, founder and CEO of ADPT Solution, discusses common issues that companies face with FDA regulations at CPHI North America.

The request for more information was received weeks after an application to the FTC was refiled to approve the deal.

Cormica’s first US Acquisition is intended to support to organic growth of TPM laboratories.

The loan is intended to support Ennogen’s growth as it looks to international acquisitions.

The report covers the major achievements of the office during 2023, including notable drug approvals, publications, guidances, workshops, webinars, and meetings.

The CDMO plans to expand and upgrade its Philadelphia, Ohio, and Milan facilities to meet the continued growth in demand for high potency handling capabilities.

Key areas to invest include manufacturing process improvements, quality management, and AI.

The non-profit initiative puts collaboration at the forefront as it tackles the challenges surrounding recycling primary pharmaceutical packaging.

The agreement, which will allow participants to share confidential information on medical and medicinal products, builds on the cooperation fostered between the two regulatory authorities during the COVID-19 pandemic.

The collaboration will combine N4’s nanoparticle delivery system with SRI’s molecular guidance system.

The majority of PMCs/PMRs are proceeding according to schedule.

A panel of experts went over new regulatory requirements for contamination control and gave guidance on implementing a contamination control strategy in cell and gene therapy facilities at INTERPHEX 2024.

Wenyu Zhang, PhD, addressed new trends in the aseptic industry and the chief concerns companies should keep in mind while weighing their options, at INTERPHEX 2024.

Zevtera has been approved to treat three types of bacterial infections and has been granted Priority Review and Fast Track and Qualified Infectious Disease Product designations.

With an ever-growing market driving technological advances, there is always work to be done in drug manufacturing.

There are considerations companies may want to consider before seeking out a service provider.

Pharmaceutical Technology gives a brief overview of some of developments in manufacturing facilities, including news from W.R. Grace & Co, ITT Inc, and SMC.

Univercells and Altamira Therapeutics are collaborating on nanoparticle-delivered mRNA vaccines, while Andelyn Biosciences and Grace Science are partnering on novel therapies for NGLY1 deficiency.

AstraZeneca’s acquisition of Amolyt Pharma includes eneboparatide, a Phase III therapeutic peptide for the treatment of hypoparathyroidism.

The Cell Shuttle platform will manufacture cell therapies for its first clinical trials by the end of the year.

The partnership will allow for both companies to provide end-to-end biopharmaceutical manufacturing solutions.

A look at the newest innovations offers a deeper understanding of affinity ligands and their role in the future of downstream processing.

The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.

The acquisition adds a potential rare disease asset to Sanofi’s alpha-1 antitrypsin deficiency pipeline.