APIs and Excipients

Unique solutions are required to protect inherently unstable messenger RNA.

This article reviews a range of techniques available for separative analysis of mRNA therapeutics, their associated impurities, and delivery vehicles.

Considerable efforts have been made over the years to resolve the key issues of stability and delivery of RNA-based therapeutics.

The complexity of the RNA production process creates challenges.

FDA has granted fast track designation to Caribou Biosciences for its allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma.

Despite the advantages intensified processes can offer developers, there are still some obstacles to overcome before broader application of new technologies will be implemented.

Impurities and batch-to-batch variability present the biggest challenges.

PharmaBlock has opened a new R&D facility in Pennsylvania, expanding its capacity to deliver GMP projects.

Curia is collaborating with Corning to advance biopharmaceutical continuous-flow development and manufacturing programs.

BioNTech will receive an exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 mAb candidate for solid tumor indications.

Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.

The collaboration between Genuv and Celltrion will utilize Genuv's proprietary mouse platform for antibody discovery.

Lipids aren’t the only important ingredients influencing stability and in vivo performance.

Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.

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

This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility.

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

Unique solutions are required to protect inherently unstable messenger RNA.

Biotech startup, Cradle, has raised $5.4 million in seed funding with an AI-enabled design platform that allows for the synthetic building of cell factories to produce proteins.

High-concentration injectable formulations present unique challenges.

The state of oral solid dose manufacturing is influenced by new approaches, novel technologies, and the structural evolution of the raw materials market.

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.

The author discusses some new applications of TPGS in the pharmaceutical field that should see this versatile excipient retain its place in the drug formulators toolbox.

CBER maps modernization plan to handle surge in research and applications.

Numerous benefits will eventually lead to large-scale applications in pharmaceutical manufacturing.

Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.

Roquette’s acquisition of Crest Cellulose is designed to reinforce its presence in India and other countries in Asia.

Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality.