Whitepapers

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.

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.

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.

Sterile filtration is essential within many steps of a bioprocessing operation, both upstream and downstream, ensuring the biopharmaceutical product’s proper performance, safety, and quality. When seeking to maximize filtration efficiency, it helps to understand how sterile filtration and single-use systems work together, as well as how optimizing the filter design for specific applications can enhance performance.

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.

Conventional freezer technology may take hours to days to recover to a -80°C set point after a door opening, leaving valuable drug product/drug substance at risk and compromising sample integrity. Watch as the FARRAR ULC Series recovers from a 30-second door opening back to -80°C in under 20 minutes.

The need for -60°C through -80°C assets to help future-proof manufacturing facilities has increased significantly over the past decade - clinical research investments have expanded while commercial-scale needs continue to transform the landscape. Cold wall remains the gold standard due to a lack of alternative solutions. Several factors, however, have placed stress on cold-wall technologies to perform in applications for which they were not designed or intended.

Grand River Aseptic Manufacturing (“GRAM”) needed commercial-scale, ultra-low temperature capacity units at -50°C delivered immediately to store forthcoming raw materials. A typical timeline for these solutions can run months, which did not meet GRAM’s needs. Working with FARRAR and creating cross-company project team enabled a typically long delivery cycle to be completed quickly and safely, with storage beginning 18 business days after the initial call (including a national holiday). Matthew Van Gessel, Senior Manager of Capital Projects and Expansion at GRAM, stated, “In a matter of weeks, the FARRAR and GRAM teams went from placing the order to installation, qualification, release, and use of the -50°C freezers. The strength in partnership and culmination of responsive communication and coordination between the two teams resulted in the expedited outcome.

The biotechnology industry is both vast and complex, with sectors varying from agricultural to pharmaceutical. Regardless of the sector, the goal remains the same – benefiting society through the creation of pharmaceutical, diagnostic, agricultural, environmental, and other products that utilize living cells and cellular materials. These products demand the development of innovative bioprocessing techniques as well as advanced equipment that can support each stage in the flow. Check out this technical article to learn more about ultra-low temperature considerations for bioprocessing.

The significant growth of the biologic drug market, bolstered by the COVID-19 pandemic and the development of relevant vaccines, along with the growing complexity and fragility of biologic drugs, has led to a need for improved freezing and thawing methods. While biologic drugs are becoming more mainstream as the pharmaceutical industry focuses on their development, maintaining high yields becomes critical to enabling timely introduction to the market and ensuring sufficient supplies. New technology exists that can help ensure higher yields and help meet demand timelines. Check out this white paper to learn more.

To help customers leverage digital transformation and prepare for the lab of the future, LabVantage Solutions has devised a five-step process for successfully implementing and profiting from AI in the lab and across the enterprise.