BPI White Papers

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…

Critical Steps to Consider During Customized Host Cell Protein (HCP) ELISA Development

The manufacturing of recombinant drugs requires comprehensive monitoring of process-related impurities, such as HCPs, as they may pose a significant health risk to patients. EMA and FDA approval relies on robust analytical data to prove acceptable HCP clearance. The enzyme-linked immunosorbent assay (ELISA) is the gold standard method for monitoring HCP content during product development and batch release testing within clinical and commercial phases. Supporting data from various orthogonal methods, including 2D Western Blot/2D DIGE analysis and mass spectrometry, should…

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…

Resource Roadmap to Screening Success: Cell-based Therapy Edition

Due to the tight link between cell culture conditions and final product quality attributes, thorough evaluation of raw materials and process parameters is critical to the development of cell-based therapies. Screening a wide array of process inputs using conventional methods and variable reagents can be costly and time consuming. This Resource Roadmap illustrates the use of the Sartorius Screening Ensemble to enable broad exploration early in development while also accelerating experimental design, execution, and validation Read this Resource Roadmap to…

Analysis of Subvisible and Visible Aggregation in Lentiviral Vectors with Aura GT

Characterizing LVV stability just got a whole lot easier. As a developer of genetic therapies, do you find yourself struggling with the complexity of lentiviral vectors (LVV)? If so, you’re not alone. Compared to protein biologics, LVVs can be more difficult and expensive to manufacture. The scarcity of LVV material also makes scale-up difficult and adds additional complexity when qualifying subvisible particles, the most indicative critical quality attribute for biologic stability. But what if there was a way to overcome…

Improving Titer, Quality and Efficiency of AAV Manufacturing and Production by Optimizing Osmolality

The rate of innovation within Cell and Gene Therapy is incredible and will continue to grow at an exponential rate as new methodologies are developed. With the novel techniques, come new and improved manufacturing procedures for sought after therapies. The use of viral vectors is now a common approach within the sector, but there are still difficulties when scaling up for bioprocessing. An example being a recovery range of 5-30%, a less than optimal result within the manufacturing process. When…

Designing a Plasmid DNA Downstream Purification Process

mRNA plasmid-based DNA vaccines, and advanced modalities using viral vectors, are at the forefront of the fight against cancer, cardiovascular, immunological, and infectious diseases. To reach their full potential and benefit as many patients as possible, however, workflows used for their manufacture must achieve greater efficiency. A critical step in the process is production of plasmid DNA (pDNA), which traditionally, delivers low yields and requires complex purification schemes. This new process development book provides you with guidance for your plasmid…

Innovations in Single-Use Technology Help Advance Downstream Processing

Biopharmaceutical manufacturers across the globe are trying to rapidly expand their production capacity to meet the growing demand for new therapies. A key challenge they face is to scale that expansion cost-effectively while protecting the quality and integrity of their production processes. One way they are achieving this growth is through expanded use of single-use systems (SUS). This informative new Avantor® Technical Article details several ways SUS technology can help improve throughput and productivity in key downstream processes that routinely…

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…