Author Archives: BPI Contributor

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.

Flexibility in Next-Generation Facilities Through Rocking Motion Bioreactors

The biopharma industry continues to face increased demands for more efficient production processes and flexible solutions. Increasing efficiency in upstream bioprocesses leads to improvements in yield, speed, and cost-effectiveness. However, an often-overlooked feature of intensifying production processes is how they contribute to a more flexible and streamlined process, essential to meet the demands of this dynamic industry. What you will learn: Understand the issues creating operational challenges for the biopharma industry. Explore how an intensified seed train can increase upstream…

Leveraging Post-Translational Modifications and Bio-Functional Assays for Characterization of Charged Variants

This webcast features: Shawn Fitzgibbons, Senior Manager & Jacob Kraus, Manager, Biologics Analytical, Catalent. The heterogeneity of a biologic product has implications for the safety and efficacy of the final biotherapeutic or biosimilar therapy. It is important to characterize the charged variant profiles of biologics, since many important post-translational modifications (PTMs) impart or alter the charge (isoelectric point or pI) of the molecule, potentially impacting stability, pharmacokinetics, and pharmacodynamics. Examples of charged variants include lysine variants and deamidation products, both…

Revolutionizing Cell Culture with Cryopreserved Pre-Plated Cell Monolayers

Cell monolayers are an ideal method and widely used in the discovery of new drug compounds and the study of cell biology. Until now, there was no cryopreservation technology available to store cell banks pre-plated commercially. The conventional approach of cell-based assay workflow was time- and resource-consuming. Now, the cryoprotectant technology CryoShield™ from CryoLogyx together with the controlled and scalable plate freeze-thaw platform RoSS.pFTU from Single Use Support, mark a revolution in commercial cell banking: Cryopreserved Thaw and Use Cell…

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…

Robust Methods for Stability and Identity Testing of Cell and Gene Therapies

This webcast features: Sameer Kalghatgi, PhD, Director of Molecular Biology, WuXi Advanced Therapies. Genetic stability and identity testing are necessary for novel cell and gene therapies to achieve regulatory approval. Sanger Sequencing, human cell line identification using short tandem repeats (STRs) and next generation sequencing (NGS), are important tools for identity and stability testing but must be implemented in a reproducible way. For regulatory approval, the identity and stability of transfected DNA inserts must be confirmed. Sanger Sequencing is widely…

Fine-tuning Transient Transfection Conditions is a Prerequisite for Optimal Upstream AAV Manufacturing

Setting up robust and reproducible bioprocesses is a top priority for all biotechnology companies focused on developing life changing AAV-based gene therapies. To do so, innovators crave for breakthrough technologies to maximize productivity while controlling the cost of goods (CoGs) of their AAV vector manufacturing workflow, key to accelerate the speed to commercialization of their clinical programs pipeline. Helper-free triple plasmid transfection of HEK293 cells – adherent or suspension – is the most used upstream method for AAV manufacture. Observing…

Enabling mRNA-Based Therapeutics Development Through Efficient and Scalable mRNA Purification Methods

This webcast features: Jenny England, PhD, R&D Manager, Innovation & Applications Group, Thermo Fisher Scientific. As a direct result of the COVID-19 pandemic, mRNA-based therapeutics development has made major progress. The potential of using mRNA as a therapy seems to be endless and an increasing number of indications is filling up the clinical pipeline rapidly. As the development of these therapies continues to rise, the industry is looking into efficient and scalable manufacturing techniques. To support the commercial production of…

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,…

Bioprocess Considerations for Large Scale Transfection

This webcast features: Geddy Hamblen, Field Applications Scientist, Mirus Bio. As demand for viral vectors has grown in recent years, larger production scales are increasingly common. As processes scale, transient transfection must also scale to match. The VirusGEN® family of transfection products, developed by Mirus Bio, has been used successfully at scale in clinical manufacturing and brings unique advantages leading to higher titers and a more robust manufacturing process. In this webinar we will discuss: Challenges and solutions for transfection…