Whitepapers

Discover how ReciBioPharm’s strategic approach helped to support the rapid delivery of an innovative oncolytic adenovirus therapy for advanced cancer to clinic.

Leveraging digital transformation and preparing for the lab of the future, LabVantage Solutions has devised a five-step process to successfully implement AI in the lab.

Discover how high-resolution biomarker assays such as Meso Scale Discovery (MSD) and advanced Mass Spectrometry (MS) go beyond the limitations of traditional ELISA assays, and how they overcome central challenges in biomarker assessment and ligand binding assays (LBAs).

This article explores process modeling and compares process economics between a conventional upstream process and three perfused seed train alternatives

This white paper provides an overview on an enabling cell retention solution resulting in greater cell-mass to achieve significantly higher titers.

In this white paper, we discuss seed train intensification strategies to leverage productivity increases and drive down costs.

Discover the benefits of using next generation processes and options to consider towards your path to upstream success.

We explore seed train intensification approaches which deliver significant upstream process improvements in speed, flexibility and reliability.

Learn about the approaches used in upstream intensification to shorten the seed train workflow, improve reproducibility, and reduce the risk of contamination.

Achieve greater upstream productivity with intensified processing via a perfused seed train.

Earlier assessment of molecules provides valuable insights into the manufacturing developability of molecules, reducing the need for unnecessary experimentation. The Intabio ZT system has the potential to make in-depth characterization of biopharmaceutical product charge variants quicker and more efficient to meet demanding timelines during early-phase clinical development.

This article describes how to achieve optimal separation of oligonucleotides and related impurities by utilizing a dedicated method development software package based on AQbD.

Learn about advanced fluid management technologies that increase safety and process efficiency at all volumes, such as ATMP aliquoting, bulk media and buffer addition, seed train intensification, high-volume bacterial fermentation, and more.

Prefabricated modular construction has gained momentum in many industries around the globe. However, traditionalists continue to have concern and resist adoption of this approach.

Our single-use technologies and sterile consumables come with the flexibility required for fast turnaround times in advanced therapeutic approaches & the handling of small volumes down to 1mL. This includes the areas of aliquotation & filtration, controlled freezing & thawing and all required logistic steps.

Fluid and cold chain management for cell-based therapies can be complex. Process steps are often performed manual and therefore prone to inefficiencies and increased product loss. And poor freezing technologies reduce cell viability. Advanced process solutions for cell culture freezing, cell banking and cell therapy help you get the best cells possible.

The manufacturing and logistics processes for small volumes of ATMPs are complex, and there are still weaknesses, particularly in the areas of inter-site transportation, aseptic aliquotation and cryopreservation. All process steps in fluid and cold chain management require robustness, ease of use, sterility and fast handling.

Want to increase the probability success for your discovery mRNA program? Partner with TriLink BioTechnologies®. Since 2012, we’ve been the industry leader in custom mRNA synthesis for research and clinical applications. Read on to see how TriLink® is determined to deliver you success.

Robust, scalable manufacturing of novel therapeutics requires partnering with a CDMO equipped to adapt to changes in the market and knowledgeable on the latest technologies used to support cell line development.

Waters is introducing new SPE sample preparation kits for oligonucleotide bioanalysis that demonstrate improved recovery and reproducibility using a standardized detergent-free protocol that minimizes method development, is automation friendly and works across a diverse range of oligonucleotide therapeutics. The webinar covers the challenges when establishing an oligonucleotide quantitation workflow and how they are addressed using this new SPE kit-based approach.

This app note reviews the development of the OligoWorks SPE Microplate Kit and detergent-free protocol for oligonucleotide bioanalysis and demonstrates performance across a broad range of chemically diverse oligonucleotides, including GalNAc and lipid-conjugated species. The analytical testing and screening work to optimize the protocol for high recovery and low matrix effects is discussed in detail and LC-MS data is presented for spiked plasma and urine samples showing excellent inter and intra-kit, day-to-day and user-to-user reproducibility (RSDs ≤15%).

This app note demonstrates automation of the OligoWorks SPE Microplate Kit and protocol using the Andrew + pipetting robot and presents quantitative LC-MS data across a diverse set of oligonucleotide therapeutics spiked into plasma. Quantitative LC-MS results from the automated detergent-free workflow are compared to results from manual processing demonstrating equivalent performance as well as excellent reproducibility, underscoring the benefits of automating the OligoWorks SPE Microplate Kit: a streamlined sample extraction workflow, reduced errors, reproducible analytical method performance and enhanced lab productivity.

In this eBook, Symbiosis explores the necessity to offer chemistry, non-sterile microbiology and sterile microbiology testing and the requirements for parenteral preparations.

A two-step mAb purification process was developed, tested, and intensified. Increased process productivity, while exhibiting robust impurity clearance and high yield, was achieved.