Manufacturing

Intensified Biomanufacturing: Achieving 3-4-Fold Higher Titers of mAbs Using Syngene’s Intensified Fed-Batch Process

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…

Drug Development – Developing Biologics for Respiratory Delivery

We bring you an informative on-demand drug development webinar, focusing on developing biologics for respiratory delivery. With drug discovery programmes increasingly focused on biological drug substances for both respiratory and systemic targets, the need to develop effective solutions for nasal and inhaled delivery is becoming increasingly vital for the industry. In this workshop, we will discuss the challenges and solutions alongside examples from real-world projects. Biologic and DNA-based modalities such as oligonucleotides, proteins, antibodies, and a range of other complex…

From Integrated Engineering to Integrated Operations: Solutions For Live Operation

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…

Best Practices for Oncolytic Virus Design, Development, and Manufacturing

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…

Comprehensive Solutions for Your Vaccine Platforms

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.

Module Type Package: Turning Visionary Concepts Into Reality

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…

Integrating PendoTECH Single Use Sensors for Industry 4.0

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,…

Enabling Capabilities and Solutions for all mRNA (Nucleic Acid) platforms – Process Development, Manufacturing and Formulation

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…

The Unique Properties of Gelatin in 3D Bioprinting

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…

Overcoming Challenges in Ophthalmic Formulations through Polymer Selection – A Closer Look at Polyvinyl Alcohol

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…