05.20.21 Making Sense Of Antibody Epitope Claims
A novel drug path to market is complex. Drug developers must navigate the journey, under growing pressure of regulation and competition while managing technical and financial risks. Challenges of gaining regulatory approval and transitioning production add to this complexity. Attend this webinar to understand the challenges when moving a bioconjugate candidate from clinic to market. Click here to learn more.
Featured Editorial
By Benjamin Pelletier, Haynes and Boone
Obtaining certain types of patent rights to antibodies has become increasingly challenging in the U.S. To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent.
Mettler-Toledo Product Inspection announces a new strategic partnership with product cloud platform architect and provider EVRYTHNG.
The partnership provides food manufacturers and brand owners with an end-to-end technology solution to join up their product data at every point in the value chain, for visibility, validation, and real-time intelligence. Having full visibility of all product data will help to identify ingredient and packaging issues early in the manufacturing process thereby reducing product recalls. Plus, if needed, the technology will be able to trace the precise location of substandard product in the marketplace for quick retrieval.
The two companies working collaboratively are positioned to further the digitalization of the food safety space. This is achieved by Mettler-Toledo ProdX, data management software, monitoring and collecting product inspection data in real-time. The software records all inspection activity from Mettler-Toledo’s Product Inspection syste
05.06.21 Why Adjusted Risk Likelihood Should Displace The Risk Priority Number
Catching up to the paradigm shift in optimizing, scaling up, and manufacturing plasmids is crucial for clinical to commercial program success for gene therapies and vaccines. With an increased demand for plasmids for targeted gene therapeutic delivery, partnering with a CDMO equipped with the capacity, expertise, and equipment for plasmid DNA production is critical to ensuring a stable therapeutic supply. Join Aji Bio-Pharma to learn about methodologies to ensure effective production and increase the likelihood of market success.
Featured Editorial
By Mark F. Witcher, Ph.D., Exyte US
While the risk priority number (RPN) primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approa
05.04.21 Top 10 Things To Consider When Installing A New pH Loop White Paper | By Frederick J. Kohlmann and Kareem Key, Endress+Hauser, Inc.
Are you looking to install a new pH loop or redo an existing loop? Whether a novice to the world of pH or a seasoned veteran, these 10 considerations provide a helpful roadmap to a successful journey. White Paper | Thermo Scientific Product Inspection
Physical contaminant prevention is important and therefore is part of every food safety plan; that is not likely to change. But what is continuously changing is the addition of new, innovative food products that require consideration of the most appropriate food safety inspection solutions. One of the fastest growing areas of innovation is plan
04.08.21 Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021
On this episode of the
Business of Biotech, Nevan Charles Elam, J.D., founder of Rezolute Bio, shares the company s rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies and discusses the company s approach to process development and manufacturing. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Philip Chen, Kayleigh McGlynn, and Jenny Shmuel, Fish & Richardson P.C.
This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors revisit the implications of the March 23, 2020, transition date, as well as the FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic.