Critical quality attributes (CQAs) are defined as a physical, chemical, biological, or microbiological property or characteristics that should be within an appropriate limit, range, or distribution to ensure the desired product quality. These essential measurements include product-specific attributes such as size, charge, and glycosylation patterns as well as process-related impurities including host cell proteins and residual Protein A from chromatographic purification. CQAs must be identified early in the discovery process, reflect the target product profile of the drug candidate, and…

Mammalian cell lines are predominantly used to produce mAbs. The current commercial production method uses fed-batch processes that exhibit productivity titers from 1- 5 g/L. Productivity is measured by the volume of products made in each batch. In the fed-batch process, the media and/or feeds are constantly supplied to the bioreactor during the cultivation, where the desired cells produce the product of interest. Productivity variation arises depending on the nature of the antibody and the specific cell line used. Higher…

From Integrated Engineering to Integrated Operations: This innovation step extends the digital value chain to include the operational phases of a pharmaceutical plant. In the last few years, ZETA has developed a digital toolbox and methodology and established the Smart Engineering Services. Faster time to market, greater cost-effectiveness and competitive capacity are the customer’s motivations for prompting ZETA to develop this proposal. End-to-end engineering, feasibility studies, concept, basic and detailed engineering up to fabrication and qualification are included in the…

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…