The development of a new, innovative drug is a highly complex and cost-intensive technical task. It normally takes more than 10 years from initial idea to first approval of a drug. As the statutory requirements for patient safety have become ever more stringent in recent years, development expenditure has increased significantly. High investment costs needed to develop some drug products are estimated to be 1–1.6 billion US dollars, which can be amortized only after market launch (1). The race against…

Pharmaceutical manufacturing is an industry laden with many challenges and risks because of the life-changing nature of its products — drugs that can affect millions of human lives. Manufacturers perform immensely complex research and testing daily while facing economic challenges and regulatory requirements. This article covers the benefits of surface plasmon resonance (SPR) in the drug development pipeline and describes a recent validation guide specifically for the implementation of SPR technology in regulated workflows. Fill out the form below to…

Clonal cell line development is a crucial step in a number of applications, including generating biopharmaceuticals (e.g., monoclonal antibodies, MAbs). Current workflows in cell line development have major drawbacks such as missing proof of clonality, inefficient single-cell isolation, and reduced cell viability. The single-cell printer™ technology offers documented assurance of clonality and provides efficient and fast single-cell seeding combined with excellent cell viability and zero risk of cross-contamination. All cytena products support SLAS/SBS format 96-well and 384-well plates. Different typical…

A high-throughput method for relative screening of terminal sialic acid content was developed on the Octet platform to expedite cell line development. The method is based on the use of ForteBio’s sialic acid (GlyS) kit to bind sialic acid on glycoproteins. The GlyS kit can screen specifically the sialylation levels of secreted proteins in crude cell culture samples and does not require purified samples. Using this method, 96 crude cell culture samples can be screened for sialylation in 60 minutes…

The natural characteristics of Chinese hamster ovary (CHO) cells have contributed to their use as the dominant expression platform in biomanufacturing. To increase the capabilities of these host systems, fundamental improvements to the CHO cell line are needed, which is where we believe that gene editing can offer a step change in biopharmaceutical manufacturing. Fill out the form below to read the complete technology review now.

Adeno-associated viruses (AAVs) are the most commonly used type of viral vector applied in gene therapy trials to date (1). From a regulatory perspective, an understanding of the critical quality attributes (CQAs) that impact product safety, purity, and potency is required. Specific analytical assays to assess vector productivity, vector purity, biological activity, and safety are required to generate data to ensure that the vector is produced with the consistency necessary to ensure safety and prevent undesired affects (2) on patients’…