Avid Bioservices is a full-service, dedicated contract development and manufacturing organization (CDMO) focused on development and manufacturing of biopharmaceutical products derived from mammalian cell culture. Avid provides process development and current good manufacturing process (CGMP) clinical and commercial product manufacturing and offers expertise supporting analytical development, qualification, and validation activities. Additional service offerings include cell line optimization, cell culture and feed optimization, product characterization, and stability testing. Avid has 26 years of experience producing a comprehensive range of proteins, including…

The ekko™ system is a good manufacturing practice (GMP)–capable platform technology for cell and gene therapy manufacturing. Based on the innovative application of acoustics, the ekko system can process cells gently and efficiently in ways that traditional mechanical and filtration methods cannot. With a wide range of operating conditions, the ekko system can be used to concentrate and wash cellular material in multiple unit operations, from early research through to GMP production. Fill out the form below to read the…

Autologous T-cell therapies no longer are limited to small, single-site trials. National and international demand is growing, bringing with it the demand for rapid scaling of manufacturing. But there is little margin for error, because any variables in an end-product could result in a potentially hazardous change to a therapy’s potency. Cryopreservation is a critical tool for quality control and transport of cells. Liquid nitrogen (LN2)–based controlled-rate freezers have long been used to freeze clinical-grade T cells. Cells are frozen…

Oncolytic viruses constitute a new promising therapeutic approach for treating cancer. These viruses selectively replicate in tumor cells and effectively kill those cells without harming normal cells. Selectively engineered, the viruses do not only destruct target tumor cells, but they also stimulate the host’s antitumor immune response. Adenoviruses are extensively characterized, well-studied viral vectors that infect both dividing and nondividing cells without the risk of integration into the host genome. Generally causing a mild nature of disease, adenoviruses are considered…

Rentschler Biopharma SE, a leading contract development and manufacturing organization (CDMO), has been at the forefront of biologic development and manufacturing for over 40 years. Our value chain encompasses the whole process: from gene to vial and from concept to market. As a full-service provider, Rentschler Biopharma offers its clients one primary contact, with only one contract signed for all phases of a development cycle. As a provider of high-end solutions for our partners, we help clients transition a project…

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…