Janet Woodcock Being Considered to Lead FDA

David Kessler is out of the running for nomination as FDA commissioner, leaving Janet Woodcock and Joshua Sharfstein as front-runners to lead the regulatory agency according to reports from Bloomberg and Biocentury. The latter notes that while the list of candidates had narrowed to Kessler and Sharfstein the delay in naming a candidate for the position could be a sign that other names are being considered. Janet Woodcock, longtime director of the Center for Drug Evaluation and Research (CDER) and a 30-year veteran of the FDA, is expected to be named acting FDA commissioner next week according to sources who spoke on condition of anonymity.
Learn More

Former Merck & Co. Employee Arrested for Stealing Trade Secrets on Cancer Research

A former director of medical and scientific affairs for immune oncology at Merck & Co. has been arrested on charges of stealing and illegally transmitting trade secrets. According to reports, Shafat A. Quadri is alleged to have copied proprietary information pertaining to multiple cancer research projects prior to leaving Merck to join AstraZeneca. Court filings state that the materials allegedly include compound data, strategic plans related to translational and biomarker data, therapeutic program reviews, abstract publications, plans for Congressional presentations, drug monitoring, and compound publication.
Learn More

FDA Sped Progress for Most of 2020’s Novel Drugs

Most novel drugs approved by the US FDA in 2020 made their way through the approvals process using one or more expedited approval pathways, and over half of sponsors received the incentives that accompany orphan drug designation, according to an FDA report detailing the year’s approvals. Novel drug approvals continued at a brisk clip, averaging over one per week in 2020. Despite the pandemic the 53 novel drugs approved in 2020 bested 2019’s 48 approvals but fell short of the 59 approved in 2018. In a report on the FDA’s novel drug approvals for 2020, FDA noted that 40%, or 21 of 53 approved drugs, are considered first-in-class. Rare diseases were addressed by 31 of the novel drugs, or 58%.
Learn More

FDA Sped Progress for Most of 2020’s Novel Drugs

Most novel drugs approved by the US FDA in 2020 made their way through the approvals process using one or more expedited approval pathways, and over half of sponsors received the incentives that accompany orphan drug designation, according to an FDA report detailing the year’s approvals. Novel drug approvals continued at a brisk clip, averaging over one per week in 2020. Despite the pandemic the 53 novel drugs approved in 2020 bested 2019’s 48 approvals but fell short of the 59 approved in 2018. In a report on the FDA’s novel drug approvals for 2020, FDA noted that 40%, or 21 of 53 approved drugs, are considered first-in-class. Rare diseases were addressed by 31 of the novel drugs, or 58%.
Learn More

Streamline Management of Day-to-Day Perfusion Processing for Improved Operations

In this latest video, part of a series of highly informative videos produced by Cytiva, subject matter experts Andreas Castan and Thomas Falkman discuss process intensification through a perfusion process.
Learn More

A New Fluorescent Probe for Selective Detection of Endogenous Cysteine and Live Cell Imaging

The detection of biothiols has attracted extensive interest owing to their vital importance in maintaining bioprocesses. Here, we reported a fluorescent probe MANK with facile preparation and excellent water solubility, which can effectively distinguish Cys from its two analogues glutathione (GSH) and homocysteine (Hcy) with a large “turn‐on” fluorescent signal of more than 40‐fold enhancement. Importantly, during the selective detection of Cys, the large concentration differences of three biothiols in living cells had been taken into account. The maleyl group in MANK acted both as a recognition site and fluorescence quenching group. And in the presence of Cys, the thiol group of Cys reacted with maleyl group of MANK by nucleophilic addition and the resulting adduct restored fluorescence emission with a high fluorescent quantum yield of 0.40 in phosphate buffered saline (PBS). Finally, it was successfully utilized to map the endogenous Cys in living cells by confocal microscopy.
Learn More

History and Evolution of Modeling in Biotechnology: Modeling & Simulation, Application and Hardware Performance

Biological systems are typically composed of highly interconnected subunits and possess an inherent complexity that make monitoring, control and optimization of a bioprocess a challenging task. Today a toolset of modeling techniques can provide guidance in understanding complexity and in meeting those challenges. Over the last four decades, computational performance increased exponentially. This increase in hardware capacity allowed ever more detailed and computationally intensive models approaching a “one-to-one” representation of the biological reality. In this review, past, present and envisioned future of models in biotechnology are compared and discussed with regard to application in process monitoring, control and optimization.
Learn More

Supporting Development of mRNA-Based Therapies by Addressing Large Scale Purification Challenges

Tuesday, February 9th, 2021

Kelly Flook, PhD, Senior Product Manager, Purification, Bioproduction Division, Thermo Fisher Scientific

Affinity chromatography, a highly scalable method, has earned its credits in the development of biologics such as the use of Protein A for the purification of therapeutic antibodies and more recently, anti-AAV resins in gene therapy workflows. An effective affinity purification step can help to simplify biomolecule downstream processing, reduce the number of purification steps, and reduce the overall cost of goods in bio-therapeutic manufacturing. To support the development of mRNA-based therapies, we have developed a new affinity resin for the purification and isolation of mRNA from in vitro transcription (IVT) manufacturing processes. This webinar will provide an overview on how this resin can help to maximize efficiency and simplify the mRNA purification process.
Learn More

Toadlet Peptide Transforms into a Deadly Weapon Against Bacteria

Researchers have discovered remarkable molecular properties of an antimicrobial peptide from the skin of the Australian toadlet. The discovery could inspire the development of novel synthetic drugs to combat bacterial infections. The researchers solved the 3D molecular structure of an antibacterial peptide named uperin 3.5, which is secreted on the skin of the Australian toadlet (Uperoleia mjobergii) as part of its immune system. They found that the peptide self-assembles into a unique fibrous structure, which via a sophisticated structural adaptation mechanism can change its form in the presence of bacteria to protect the toadlet from infections.
Learn More

Heatseal Sampling

A U.S. Patent for "Heatseal Sampling" was awarded to Global Life Sciences Solutions on December 8th, 2020. The present invention is a device for taking a sample from a liquid cell culture in a bioreactor wherein said device comprises: (i) a hollow body comprising outer walls that define a fluid path therethrough wherein said outer walls are at least partly comprised of a sealable material, wherein said fluid path begins at an upstream end of said hollow body, through said hollow body, and ends at a downstream end of said hollow body, and wherein said upstream and downstream ends are adapted to fluidly connect said fluid path with an interior of said bioreactor, wherein the liquid cell culture flows from the interior of said bioreactor into the fluid path via the upstream end and flows back to the interior of said bioreactor...
Learn More

1929 – Martin Luther King Jr. was Born in Atlanta, Georga

On January 15, 1929, Martin Luther King, Jr. was born in Atlanta, Georgia. King received a doctorate degree in theology and in 1955 helped organize the first major protest of the African American civil rights movement. The peaceful protests he led throughout the American South were often met with violence, but King and his followers persisted, and the movement gained momentum. A powerful orator, King appealed to Christian and American ideals.
Learn More

Do you think of yourself as more of a “cat person” or a “dog person”?

Cat person
Dog person

Click Here to Participate

I Have a Dream…

On August 28, 1963, Dr. Martin Luther King, Jr. delivered a speech to hundreds of thousands of Americans at what is known as the March on Washington. This now-famous speech was both an apex and catalyst for the Civil Rights Movement in the US. Rediscover the richness of this speech and the significance of Dr. King's four words, "I have a dream."
Learn More

Fujifilm Investing $2 Billion to Build Large Scale Biologics Manufacturing Site in U.S.

Fujifilm Corporation is investing more than $2 billion to establish a new large-scale cell culture production site in the U.S. This new facility will offer large-scale cell culture manufacturing of bulk drug substance with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add a further 24 x 20,000L bioreactors based on market demand. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. The new site will be built within the vicinity of an existing Fujifilm site, and is scheduled to begin operations in the spring of 2025. Fujifilm Diosynth Biotechnologies will operate the new facility.
Learn More

An Intelligent and Gifted Student, King Entered College at the Age of 15

King was such a gifted student that he skipped grades nine and 12 before enrolling in 1944 at Morehouse College, the alma mater of his father and maternal grandfather. Although he was the son, grandson and great-grandson of Baptist ministers, King did not intend to follow the family vocation until Morehouse president Benjamin E. Mays, a noted theologian, convinced him otherwise. King was ordained before graduating college with a degree in sociology.
Learn More