Real-time product attribute and spent media information is important to upstream bioprocess optimization, analysis results are often lagging by weeks. Engineers can now take decisions faster by producing their own at-line quality data, accessible workflows coupling small bioreactors like Sartorius Ambr systems to Waters’ BioAccord LC-MS system. Drug quality and yield can be maximized, and downstream impurities minimized. Development is accelerated from weeks to days, saving resources from multiple optimization cycles.

The National Biologics Facility at the Technical University of Denmark offers cell line development and protein production services to both academics and industrial customers. This is done in an academic setting and meets all the requirements of an industrial facility. The advantages of a dynamic academic research environment are combined with the documentation and regulatory requirements necessary for the production of biologics that can be used in industrial settings. This results in a flexible and quick responding unit, as well as a platform for education and transfers new discoveries and technologies into the industrial space.

The Jackson Laboratory pioneered the use of mice as models for human disease. Today, it discovers precise genomic solutions for human diseases.  JAX Protein Production and Purification Service enables the faculty to advance newly identified genes to the proteins they encode.  While producing proteins, the service focuses on educating the geneticists about proteins. It strives to provide high-quality services while understanding the limits determined by being a small service. 

Moving from research-based operations to projects that have GxP requirements can be challenging in a university or start-up. Structural as well as cultural issues can hamper progress. This talk will describe experience in moving from research-based operations to projects that require increasing amounts of documentation. Topics will include how to implement a documentation system, how to manage equipment qualifications, as well as staff training and culture.

This presentation discusses the need for identification of exquisite specificities in mAb discovery.  It demonstrates GSK’s use of automation to keep the discovery funnel wider for longer. This includes the ability to express and purify panels of antibodies in a high-throughput, automated manner, enabling parallel biological and developability screening, and accelerating the drug discovery process.

Early-stage drug discovery demands the highest quality protein reagents in support of assay development and deployment, biochemical and biophysical measurement, and structural biology. Failures to control protein quality can lead to lost time and money and adversely impact downstream colleagues and collaborators. We discuss the standard processes used to control protein quality at the Frederick National Laboratory's RAS Initiative and lessons learned from the many proteins we have produced.

This presentation covers the protein production setup at Pfizer in San Diego from small-scale triage to multi-liter scale-up capabilities. Various techniques employed to characterize the proteins produced in a fit-for-purpose manner, including some specific examples (eg: SEC-MALS, DLS, DSF, ITC, Mass Photometry, Microscale Thermophoresis, etc.) will be discussed.

The baculovirus expression system is a powerful and widely used methodology to generate large quantities of recombinant protein. However, resource challenges exist with the system; these include time and effort to generate, screen, and store large numbers of viruses. We have developed a streamlined process to QC new viral constructs by incorporating; 1) Off-the-shelf automation platforms 2) Screening miniaturization techniques and 3) Data management platforms. This workflow accelerates viral generation through an improved screening funnel and reduces the total number of viral samples that need to be managed thereby making handling and storage more efficient.

Stable CHO pools, generated during cell line development (CLD), can be used to purify material for multiple lead candidates. While CLD continues, in depth characterization of candidates can be combined with knowledge gained on their performance in platform USP and DSP conditions, adding manufacturability data to lead selection. The material produced can also be used to drive key development activities, moving these off the critical path and reducing timelines to IND.

The sample pre-purification processes of centrifugation, filtration and concentration of cell culture supernatants and/or lysates coupled with the post-purification concentration of purified protein eluates represent the most costly and labor-intensive components of a typical protein purification workflow. We describe a novel technology to eliminate these steps through target capture directly in live cell culture or lysates using magnetic beads.

The COVID-19 pandemic put many scientific communities in the race to develop an effective vaccine. We generated recombinant protein antigens derived from the receptor binding domain (RBD) of SARS-CoV-2 spike protein and developed a vaccine. Here we present the purification method developed to produce highly pure RBD protein from the fermentation culture of P. pastoris. Furthermore, we optimized the purification process to support fully scalable production at a low cost.

Although tags can enable the rapid purification of proteins for research, their potential immunogenicity precludes their use for clinical material. Consequently, research and clinical production groups have been separated by the different approaches needed to fulfill their customer needs. Here we report our commercially available self-removing affinity tag technology, with the potential to bridge high-throughput research with large-scale clinical production under a single, uniquely optimized purification platform.

Protein production is more complex than just the act of expressing the protein. This presentation reviews the end-to-end protein production workflow process including establishing a roadmap for the short-and-long-range planning and outfitting of a protein expression laboratory, determining what expression systems will be critical components of your expression toolbox that can adequately and efficiently support your protein production needs, the complexity of the total protein production workflow (Cloning, Expression, Purification, and Analytics) and how to identify opportunities to increase its efficiency and productivity in a recombinant protein expression facility.

Drug Discovery landscape is ever evolving and constantly demands revolutionary advancements in protein production core laboratories. This presentation will focus on the evolution of our end-to-end automated high-throughput protein expression and purification workflows. It will emphasize the importance of automation and bioinformatics tools that are integrated to provide efficient solutions. This customizable “one for all” approach significantly alleviates some of the bottlenecks in protein production and accelerates the provision of key protein reagents to ambitious projects particularly for challenging and undruggable targets.

In an industry facing increasingly challenging deliverables, the ability to rapidly build synthetic DNA, mRNA, and protein is critical. Imagine a development pipeline where it was possible to build biology overnight. Join us to learn about how the BioXp^TM System, the world’s only fully automated benchtop instrument enables numerous synthetic biology workflows by providing a turn-key, end-to-end solution for generating synthetic DNA and mRNA starting from DNA sequence.