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The breakthrough approach is commonly used, but the devil is in the details.
In this article, a simple chromatographic model is proposed that is capable of predicting the impact of pH and ionic strength on HIC chromatograms.
The COVID-19 vaccines opened the door to powerful market potential for other nucleic acid-based therapies.
The innovation of going from stainless-steel bioreactors to fixed-bed bioreactors shows an evolution in upstream optimization.
Makers of specialty biologics, gene therapies, and other personalized medicines are working to identify and reduce potential supply chain risks both upstream and downstream.
FDA has spurred investment to create and develop 600 therapies.
What can we take away from Pfizer's acquisition of Seagen?
May 16, 2023
In a brief, the Federal Trade Commission cited concerns about the acquisition resulting in an increased monopoly on Amgen’s newly acquired thyroid eye disease and chronic refractory gout treatments.
The NSF-sponsored program aims to help partners collaborate to create opportunities for significant economic, societal, and technological opportunities for growth in their regions.
Under the collaboration, BiOneCure Therapeutics and Nanjing Leads Biolabs intend to develop a range of innovative antibody-drug conjugates for treating solid tumors.
Synthego has opened its new GMP-compliant RNA manufacturing facility in Redwood City, Calif., for CRISPR-enabled genomics therapeutics.
The data, published in the scientific journal Nature, demonstrated that half of patients developed T cells that could potentially fight pancreatic ductal adenocarcinoma.
The first CleanCap analog was launched in 2017, and since then, the capping technology has been incorporated in one of the first commercially approved COVID-19 vaccines.
Outsourcing collaborations provide insight into the key drivers of market growth.
May 15, 2023
Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.
Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.
To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.
The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.
Forge will provide adeno-associated virus (AAV) process development, toxicology, cGMP manufacturing, and analytical services to Life Bio, which will occur at Forge’s gene therapy facility in Columbus, Ohio called the Hearth.