Whitepapers

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.

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.

When developing a new drug product, quality, safety and timing are critical. A Contract Development and Manufacturing Organization (CDMO) can be a valuable partner to help mitigate risks, avoid missteps and control costs in the process. But the success of the partnership revolves around a key step: the technology transfer.

Cell and gene therapies offer new opportunities for the development of potentially life-saving treatments for previously incurable diseases. This eBook informs on bioprocess solutions to support novel drug development.

This note demonstrates identification of Infliximab charge variants from intact mass analysis enabled by two-dimensional liquid chromatography

Vetting contract fill finish manufacturers is about more than their capacity. Jubilant HollisterStier advises on what to look for in a sterile fill finish partner.

Is software critical to your success with Multiple-Attribute Methods? Hear from experts across the industry in volume 5 of our Expert Discussion Series. Learn about their perspectives on informatics requirements for MAM.

Hear from experts across the industry in volume 1 of our Expert Discussion Series on Multi Attribute Methods. Learn about their perspectives on the opportunities and challenges of implementing MAM in their lab.

How confident are you deploying LC-MS systems for Multi-Attribute Methods in routine labs? Hear from experts across the industry in volume 6 of our Expert Discussion Series on Multi-Attribute Methods. Learn about their perspectives on system requirements for MAM.

Download this eBook for fresh perspectives on the capabilities and adoption of MAM workflows within the biopharmaceutical industry.

How to handle new peak detection with Multi-Attribute Methods? Hear from experts across the industry in volume 3 of our Expert Discussion Series. Learn about their perspectives on the considerations of new peak detection

Download this application notebook illustrating key attribute monitoring workflows developed to improve and streamline MAM analysis of biotherapeutic proteins.

Can you really deploy a Multiple-Attribute Method in a routine lab? Hear from experts across the industry in volume 4 of our Expert Discussion Series.

Hear from experts across the industry in volume 2 of our Expert Discussion Series on Multi Attribute Methods. Learn about their perspectives on MAM sample preparation and automation.

Designed for advanced therapy manufacturing, the Marlborough, MA facility is the first new construction at Resilience. The site will produce, rest, and release viral vector drug substance (DS) and drug product (DP), for clinical and commercial use.

When it comes to viral vectors, the complexities related to varying serotypes and different sized payloads continue to impact efficiencies and timelines. Hear from Resilience experts on how innovative platform technologies can overcome these challenges and support scalable manufacturing.

There are many reasons behind the success of a technology transfer. But at the center of this complexity is one critical role: project management in the tech transfer.