Oncolytic viruses (OVs) have the potential to become a very important pillar in the treatment of cancer because of their dual mechanism killing infected cancer cells and triggering anticancer immune response to also destroy uninfected cancer cells. This motivates researchers continually optimize oncolytic viral vectors to further improve their safety, efficacy as well as manufacturability for a commercial scale-up. As biopharmaceutical manufactures just begin to explore the prospect of OVs based therapies, the need for contract development and manufacturing organizations…

You want to scale and deliver your vaccine to the world quickly. Our collaborative global vaccine capabilities will take your innovation from pre-clinical to full-scale GMP-manufacturing efficiently, safely, and cost-effectively. Our new handbook describes how our global capabilities can help you achieve these goals for all your modalities/platforms including inactivated/live attenuated vaccines, subunit vaccines, VLP vaccines, viral vector vaccines, pDNA vaccines, mRNA vaccines.

Versatile, modular plants are the process industry’s response to constantly changing market requirements. The development of standards for integrating individual modules into the pharmaceutical production process is currently in full swing. The Module Type Package (MTP) approach designates each module with its digital description, enabling highly flexible module connection and orchestration. ZETA is currently involved in a joint modular automation initiative with Rockwell Automation. Future production plants can be assembled quickly and easily from individual modules with different functions. Depending…

Industry 4.0 refers to the ongoing Fourth Industrial Revolution, which is currently transforming modern manufacturing and production practices through the use of smart technology and artificial intelligence. At a high level, Industry 4.0 has paved the way for the integration of manufacturing execution systems (MES) with enterprise resource plan (ERP) systems and supervisory control and data acquisition (SCADA) systems. Biopharmaceutical manufacturing is currently evolving with the progression of Industry 4.0. The integration of business and manufacturing systems in an intelligent,…

Conquer the mRNA era. Advancing together from initial idea to final product. Your molecule’s journey to the market is a long and complex one. You need an experienced and trustworthy partner who understands the varying challenges you face and helps you solve them efficiently, safely and speedily. No matter whether you’re still in the idea stage, ready to scale up your production or need specific regulatory know-how for a successful launch of your mRNA drug. From mRNA development and manufacturing…

How to select the right bioink to secure proper cellular characteristics and functionalities in engineered tissues: exploring the benefits of low endotoxin gelatins. Gelatin has long been a trusted excipient in the pharmaceutical industry. For advanced biomedical applications like in-body use, there are strict regulations for endotoxins levels of the final product (medical device) to avoid unwanted side-effects. 3D bioprinting is a very popular tissue engineering technology used in the field of regenerative medicine. In this whitepaper, we explore the…

Ophthalmic drug formulations are growing in importance due to the increased prevalence of eye-related disorders such as diabetic retinopathy and macular degeneration. However, ocular drug delivery is challenging due to unique anatomical and physiological barriers such as pre-corneal loss factors including tear turnover, nasolacrimal drainage with potential systemic absorption via the conjunctiva or nasal mucosa, transient residence time, and the relative impermeability of the corneal epithelial membrane. The low ocular bioavailability (<10%) of conventional ophthalmic formulations is driving the need…

The bio/pharmaceutical industry is rapidly changing with increased product complexity, shorter timelines, and a push from the FDA for less human intervention in aseptic processing. These changes can often introduce additional risks to the sterile fill/finish process, resulting in production delays, additional costs, and safety concerns. Eurofins BioPharma Product Testing can help eliminate human error and other associated risks when producing small batches of sterile GMP product for Phase 1 and 2 trials using our state-of-the-art Vanrx Microcell Vial Filler…

HEK293 cells are a dominant platform for cell and gene therapy production because they are highly effective at producing large amounts of recombinant viral vectors. However, it is critical to remove trace host cell contamination from therapeutic products to avoid endangering patients. To meet rigorous regulatory guidelines, biopharmaceutical manufacturers need a HEK293 detection method that delivers high-quality, quantitative data with a simple, reliable workflow. This white paper discusses the transition from quantitative PCR (qPCR) to Droplet Digital PCR (ddPCR™) for…