Whitepapers

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 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.

A subscription-based LIMS, hosted in the cloud and delivered via internet, is a proven secure, scalable, and cost-effective alternative to traditional software licensing, installation, maintenance, validation, and management. Learn all the benefits of a SaaS delivery model for modern lab informatics solutions.

In this white paper, learn how to drive growth by establishing integrated, AI-fueled lab systems and a data-driven corporate culture that’s ready and resilient, no matter what business challenges emerge tomorrow.

Digital transformation is about more than moving from paper to glass. It’s about the way that enterprises use technology and data to build a business ecosystem, thereby reducing risk, accelerating innovation, and driving growth.

Non-infectious mock virus particles that mimic the physicochemical properties of live infectious viruses can be used as spiking agents during viral clearance testing.

Intensified continuous chromatography, a type of Multi-Column Chromatography (MCC), has emerged as a valuable technique in downstream bioprocessing that enables increases in productivity. In this podcast, MCC Product Specialist, Jennifer Knister, will discuss how adopting MCC can reduce costs, decrease suite time, and lead to higher resin utilization, along with why these benefits are particularly worthwhile in multi-product facilities.

This research outlines recent changes in the monoclonal antibody market, the great potential for pathogen-focused mAb treatments and important industry factors impacting how to antibody products can navigate through clinical stages.

Biopharma Resilience is declining. The 2023 Global Biopharma Resilience Index from Cytiva offers insights into the current state of the industry, shining a light on both areas of strength and opportunities for collaborative growth. By working together, biopharma leaders, academia, and policymakers can create lasting improvements. Join Ludovic Brellier, President of Biotechnology Integrated Solutions and Business Operations Leader at Cytiva, as he delves into this year’s Index findings. Specifically, he’ll highlight where the industry should turn their focus to ensure that patients are continuing to get the essential life-changing therapies they need.

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.

In this work we discuss an automatable sample preparation protocol for peptide mapping used in QC, bioprocess, analytical development, and research environments to deliver comprehensive information about the primary structure of biotherapeutic proteins.

As more biologics move through research and development, the demand for specialized aseptic fill/finish services has steadily climbed. Aseptic processing with the highest degree of sterility assurance, filling accuracy and quality is critical for high-value, small-batch therapies. Anything less impacts regulatory compliance, project timelines and—most importantly—patient safety. This white paper explores the specialized equipment, expertise, and services needed for efficient biologics fill/finish manufacturing.

In this work we discuss an automated high-throughput sample preparation method and fast LC-MS peptide mapping for Critical Quality Attribute (CQA) peptide measurement that was developed for low volume and low concentration microbioreactor samples.

In this work we discuss how to achieve complete and clean trypsin digestion with an enzyme that provides a balance of missed cleavage, non-specific cleavage, and trypsin autolysis.

This SGS Health Science whitepaper uncovers the changing regulatory environment, and the challenges posed by the detection of nitrosamine impurities in drug products.

Bioprocessing for protein production is a time-consuming process, typically lasting about two weeks. It is increasingly desirable to routinely monitor critical process and product attributes such as changes in nutrient profiles and high level glycoform information for the drug substance. Read our latest application note to learn how the newly launched bioprocess walk-up solutions enable bioprocess engineers to collect attributes easily and rapidly for process related monitoring and optimization using the Andrew+ Pipetting Robot, Waters OneLab Software and the BioAccord LC-MS System.

Waters bioprocess walk-up solutions unlock access to high quality process and product data with just a few clicks, even for users with little knowledge of mass spectrometry. Providing streamlined integration of automated sample preparation and LC-MS analytics simplifies, accelerates and advances your bioprocess development.

This report explores rapid vaccine development during the pandemic and how process changes with the help of advanced manufacturing could aid the development of medicines.

Cell culture media is a foundational component of any biotherapeutic manufacturing workflow, crucial for maintaining cellular health and viability, maximizing titers, and supporting high product quality. As such, building a biotherapeutic manufacturing process with an optimized basal medium and feed system is vital to achieving optimal results and accelerating the speed-to-market of your product. However, the process of finding the most suitable basal medium and supplementation strategy can be challenging, as it requires balancing many key cell culture process variables to achieve specific technical goals within budget and time constraints. This guide will provide an insight into each development stage and offer best practices to help you achieve your project goals on time and within budget.