Wednesday, February 3, 2021 Daily Archives

Silicone Tubing for Biopharmaceutical Applications: Particulates, Endotoxins, and Bioburden Characterization

by

Adoption of single-use systems (SUS) has increased steadily over the past few years driven by an increased focus on manufacturing biologics that require smaller scales than blockbuster drugs. Although SUS provide many benefits, some factors need to be considered when implementing them in biopharmaceutical production. With the regulatory landscape intensifying worldwide, drug manufacturers are expecting more data from suppliers to support the purity claims of supplied products, especially related to the purity of their product-contact surfaces. In this article, we…

February 3, 2021

A Universal Assay Determination Method for Antisense Oligonucleotides: A New Slope Spectroscopy Method

by , , and

Antisense oligonucleotides (ASOs) are short, synthetic, single-stranded oligodeoxynucleotides that can alter RNA and reduce, restore, or modify protein expression through several distinct mechanisms. ASO technology has become an important drug discovery platform for most major pharmaceutical companies. To date, six antisense drugs have been approved by regulatory agencies to treat diseases spanning viral infections, hyperlipidemias, and neurological diseases. More than 50 additional ASO drugs are in clinical trials. For an ASO drug product, an assay of its active pharmaceutical ingredient…

February 3, 2021

Ask the Expert: Enabling Digital Chromatogram Review to Streamline Column Evaluations

by

Chromatogram review enables evaluation of packed-bed chromatography processes. Typically, that method entails paper-based, qualitative comparison of a profile obtained during a run with another from a reference batch. Such a protocol can be time consuming, resource intensive, and susceptible to operator error. Martin D. Jensen (senior engineer at Fujifilm Diosynth Biotechnologies, FDB) delivered an “Ask the Expert†presentation on 20 October 2020 to describe advantages that his company gained by transitioning from paper-based to digital chromatogram review. Jensen’s Presentation Chromatogram…

February 3, 2021

Ask the Expert: Revealing Cell Secrets Using Optical Sensors in Upstream Processing

by

Upstream operations can benefit significantly from real-time, in-line testing of cell-culture conditions. Yet as Jake Boy (senior application scientist at Scientific Bioprocessing Inc., SBI) observed in his 5 November 2020 “Ask the Expert†webcast, traditional electrochemical probe sensors do not perform well in T-flasks, shake flasks, Petri dishes, and microfluidics devices. Boy described how fluorescence-based optical sensors can glean valuable data from small culture devices, assisting with research into cellular growth. SBI’s Presentation Boy began by highlighting successful applications of…

February 3, 2021

Ask the Expert: Derisking INDs with Unrivaled Monoclonality Assurance in Cell-Line Development

by

On 1 December 2020, BPI presented an “Ask the Expert†webinar with Tanner Nevill (vice president of program management at Berkeley Lights). Monoclonality assurance is a central regulatory requirement for all cell lines producing biologic therapies. Well-plate imaging is the “gold standard†for confirming that a cell line originates from a single cell, but it is labor intensive and prone to errors in the form of “ghost cells†and debris that look like cells. Using the Berkeley Lights Beacon system, cells…

February 3, 2021

Therapeutics Innovation in a Pandemic Era

by

Biopharmaceutical companies have demonstrated a rapid and powerful response to the COVID-19 pandemic, with innovators leading the way. A rush of investor money has been pouring into companies with the best odds of making it to the vaccine finish line. But such heavy investments in one sector lead some industry experts to wonder about the financial support of research into cure pathways for other serious diseases such as cancer, multiple sclerosis, and Alzheimer’s disease. When the pandemic abates with vaccines…

February 3, 2021

Merck partners with Artiva to develop off-the-shelf CAR-NK therapies

by

Merck & Co. has paid Artiva Biotherapeutics $30 million to develop up to three off-the-shelf CAR-NK cell therapies. On top of the $30 million Artiva has received for the first two programs, an additional $15 million will be paid by Merck (known as MSD outside of North America) if they decide to opt for a third program. Artiva has the potential to receive up to $612 million per program depending on future development, commercial milestones and global sales of the…

February 3, 2021

Pfizer cites ‘simplicity’ of mRNA production to overcome COVID-19 variants

by

Pfizer says it is relatively simple to rejig the formulation and manufacturing infrastructure for its approved mRNA vaccine in the case of COVID-19 variants. Following a year that saw Pfizer bring to the US and Europe the first vaccine against COVID-19, the firm has raised its production targets for 2021 from 1.3 billion doses to 2 billion doses, and expects to deliver 200 million doses to the US by end of May. “Because of the dire need to vaccinate more…

February 3, 2021

Rentschler, Bayer and GSK on board to ramp up CureVac COVID-19 candidate

by

Rentschler Biopharma is poised to begin large-scale production of CureVac´s candidate COVID-19 vaccine, CVnCoV. Meanwhile Bayer will ramp up production, and GSK is on board to make a further 100 million doses this year. Rentschler, a German contract development and manufacturing organization (CDMO) announced it is gearing up to start commercial production at its Laupheim facility this week. It said it is optimizing the process to increase mRNA yield, adding it expects to produce more than 100 million doses per…

February 3, 2021

Thermo says COVID-19 vaccine and therapy work will generate $1bn in 2021

by

Thermo Fisher Scientific cited COVID-19 as a revenue driver in 2020 and predicted that pandemic-related work will make an even bigger contribution this year. Thermo’s revenues grew 26% in 2020 to $32.2 billion with COVID-19 testing and vaccine and therapy-related development activity generating $6.6 billion. The contribution from Thermo’s pharma and biotechnology business grew 25% in Q4 driven by increased demand for COVID-19 related bioproduction, pharma and bioscience services. Revenue from academic, government and industrial customers also increased as result…

February 3, 2021