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Often, aggressive timelines are imposed on development projects with the aim of getting to First-in-Human trials as soon as possible. However, formulation development can be met with many challenges as biologics are often sensitive molecules with a v...

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In this GEN webinar, our guest speakers, Dr. Tyler Jones and Senior Research Scientist Dylan Ting will discuss strategies to leverage efficiency from cell line development to clinical manufacturing of biologics. Moreover, we will hear how proprietary...

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Ensuring the safety and efficacy of pharmaceutical products is paramount in the healthcare industry, making the FDA's Quality Management Maturity (QMM) program and CDER's proposed rating system crucial for Contract Development and Manufacturing Organ...

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Advances in disease biology have led to the burgeoning development of bispecific antibodies (BsAbs), which are synthetic proteins capable of targeting two discrete epitopes from different antigens. Their bispecific functionality offers promising ther...

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Lyophilization, also known as freeze-drying, is often a crucial step in the manufacturing process of biologics drug products. Biologics are large, complex molecules used to treat various diseases, including cancer, autoimmune disorders, and rare gene...

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In the fall of 2021, the Delta variant of SARS-CoV-2 was the dominant strain in the US, being both more contagious than previous variants and more likely to lead to “long COVID” than subsequent Omicron variants. Here we describe the discovery and...

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A large portion of innovative companies are in discovery, preclinical or early clinical stages with therapeutics aimed at oncology and infectious diseases. There is promising growth in overall biologics therapies, driven by increased funding and grow...

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With experience in both chemistry and biologics, Curia is uniquely positioned to provide mRNA drug development solutions spanning discovery and engineering, mRNA drug substance formulation, and fill-finish and manufacturing of lipids and nucleosides.

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The number of FDA-approved monoclonal antibodies (mAbs) continues to grow, while those in late-stage development rose more than 30% between 2021 and 2022.

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Hybridoma technology is a popular method for antibody discovery, but the conventional approach of using a single inbred mouse strain for immunization fails to generate the diversity and antibody titers needed to maximize the discovery of high-quality...

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The combination of the PentaMice® platform and single B cell screening with the Berkeley Lights Beacon® Optofluidic system increases speed to market for monoclonal antibody therapeutics.

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The clinical value of biologics for the treatment of many disease indications has been accompanied by phenomenal sales. By 2026, the global market for biologics is projected to increase to $537 billion. However, getting a promising drug candidate fro...

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