Creative Bioarray Develops Cutting-Edge Solution for Ensuring Clonality in Recombinant Protein Therapeutics Production

Creative Bioarray Develops Cutting-Edge Solution for Ensuring Clonality in Recombinant Protein Therapeutics Production

SHIRLEY, NEW YORK, USA, July 1, 2024 /EINPresswire.com/ -- In the fast-paced world of pharmaceuticals, recombinant protein therapeutics, also known as biologics, play a crucial role in the treatment of various diseases. Clonality Analysis of the Production Cell Bank has long been the go-to expression system for producing these important pharmaceuticals. However, ensuring clonality in the development of stable cell lines for novel biopharmaceuticals or biosimilars has emerged as a key factor in the process.

As the industry shifts its focus towards proof of clonality, Creative Bioarray has stepped up to provide a game-changing solution. Many companies have encountered challenges during the IND review process of their biological products related to clonality. The concept of clonality is centered around minimizing the heterogeneity of cell banks to enable consistent manufacturing of a product.

Through recent advancements in technology such as single cell sorting and high-throughput imaging, Creative Bioarray offers a reliable method for acquiring evidence that supports clonality. Traditionally, rederiving a clonal cell line through additional limited dilutions has been a time-consuming and costly process that could potentially impact production and growth rates. This is particularly concerning when tight timelines for submission are at play.

Creative Bioarray's cutting-edge approach involves genetic characterization of (CHO) producer cell lines by Fluorescence In Situ Hybridization (FISH), providing valuable information on transgene integrity and integration sites. By utilizing this innovative technology, the company is able to offer a comprehensive solution that ensures not only clonality but also maintains the efficiency and productivity of the cell lines.

With Creative Bioarray's expertise in genetic characterization and clonality assessment, pharmaceutical companies can confidently navigate the complexities of developing stable cell lines for recombinant protein therapeutics. By partnering with Creative Bioarray, organizations can streamline their production processes, minimize risks associated with clonal heterogeneity, and ultimately enhance the quality and consistency of their biopharmaceutical products.

In an ever-evolving landscape of biopharmaceutical development, Creative Bioarray stands at the forefront of providing cutting-edge solutions that drive innovation and efficiency in the industry. With a commitment to excellence and a dedication to advancing the field of recombinant protein therapeutics, Creative Bioarray continues to be a trusted partner for companies seeking to optimize their biopharmaceutical production processes.

About Creative Bioarray

Creative Bioarray is a leading provider of research services for drug discovery and development. With a team of experienced scientists and state-of-the-art facilities, Creative Bioarray offers a wide range of services to support all stages of drug discovery, including in vivo disease modeling, preclinical toxicology studies, and pharmacokinetic studies.

Hannah Cole
Creative Bioarray
+1 631-386-8241
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