This week’s headlines include: Widespread Testing Begins on Malaria Vaccine That Is Only Partly Effective, AbbVie’s Skyrizi drug to treat psoriasis wins U.S. approval, Lilly, Avidity to Partner on Immunology Drugs in Up-to-$440M Collaboration, and Mustang flying high as ‘bubble boy’ gene therapy aces small study.

Podcasts:

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In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

Next Generation Cell Viability Analyzer Vi-CELL BLU Cell Simplifies and Speeds Workflow

Beckman Coulter Life Sciences just launched its next generation cell viability analyzer, Vi-CELL BLU. As part of the launch, Lena Lee, Global Product Manager for Vi-CELL was interviewed about improvements over the legacy analyzer. The Vi-CELL has been helping researchers for over 20 years to monitor the health of their cells by providing total cell concentration, percent cell viability, and cell size (another indicator of cell health)…

Minimize Cell Culture Contamination and Batch Failure by Creating a Closed System for Cell Culture Expansion

Batch failure due to cell culture contamination is a serious consideration for biomanufacturing. A recent BioPlan Associates Survey examined the frequency, cost and leading causes of batch failure. They found that on average a failure occurs every 9.4 months and costs companies $1 to $2 million. The leading causes of batch failure were contamination and operator error. It is logical that anytime the cell culture system is open, for instance when opening flasks during cell expansion, there is an opportunity for contamination…

End-to-End Integrated Manufacturing Solutions Enable Gene Therapy Commercialization

The past decade has seen a surge in the development of gene therapies. Currently there are over 1,000 cell and gene therapy clinical trials underway worldwide.¹ While the majority of current trials are still in Phase I or Phase II, there are more than 90 trials in Phase III. In fact, at last year’s BIO International Convention, Scott Gottlieb, Commissioner of the US Food and Drug Administration (FDA) stated that he expects the FDA to approve 40 gene therapies by 2022.²…

Biologic Products DNA to IND Timeline in 9 Months – Yes it can be done!

The ability to rapidly develop biologic products from conception to human clinical trials is an increasingly important aspect of controlling drug development costs and in expediting the drug’s pathway to one day provide critical treatments. Hence, there has been an increased focus on ways to shorten the timeline through product development. These expedited timelines are especially important when dealing with infectious disease control…

Using cell culture models of endocrine resistance to improve triple positive breast cancer treatment options

Gibco Cell Culture Hero, Dr. Hillary Stires discusses her work researching better treatment options for triple positive breast cancer patients. She explains how the use of cell culture modeling helps drive her research. She also talks about her experience as a cell culture hero and her passion for the scicomm movement on social media platforms…

Cool Tool – Innovative sorbents enable a robust and streamlined protein purification process

Monoclonal antibodies have long been purified using a platform approach. This platform mainly consists of three chromatography steps. These include a Protein A based affinity chromatography step followed by polishing steps. The purpose of the affinity chromatography is to capture the mAb, while the polishing steps remove any remaining impurities, such as residual DNA, host cell proteins, viruses and aggregates. There are options in the selected polishing steps, but often they involve cation exchange or hydrophobic interaction. Increasingly membrane chromatography is being used as a polishing step to remove any remaining contaminants…

Optimizing mAb Purification with Highly Selective Mixed-mode Cation Exchange Sorbent

In today’s market, mAbs are produced for several therapeutic applications, yet they are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability to aggregate; the contaminant HCP content is also process-dependent. As drug manufacturers seek to produce mAbs for various application, they are also looking to streamline processes for efficiency and quality…

Scalable Protein A Chromatography for High-Throughput Process Development

Process development is a critical part of biomanufacturing, but it can be very time and resource intensive. With recent industry initiatives around speed to market, process development is an area that could really benefit from high throughput solutions. One high-throughput process development tool for chromatography is the use of 96-well plates. These plate platforms permit automated screening of large numbers of conditions very efficiently and use only a small amount of material for testing. This platform is great for screening but requires bridging experiments to translate results to process scale. In addition, automating the 96-well process requires investment in liquid handling equipment in order to reach the full potential of the platform…

Utilizing High-Throughput Process Development Tools to Create a Purification Process for a Biosimilar Molecule

Biosimilar molecules have some unique manufacturing requirements that must be taken into account when planning process development. The requirements for process development typically require a good deal of selectivity, cost-efficiency and the need to meet aggressive timelines. These lend themselves to a process development approach that incorporates high throughput…

Designing a Viral Clearance Study – A Step by Step Tutorial

Viral clearance testing is a regulatory requirement and critical part of the overall approval process for all biologics. Viral clearance testing is performed at two points in biologics development. Before Phase I clinical trials, viral clearance studies are conducted to demonstrate the capability of a downstream purification process to eliminate potential viral contaminants…

Webinar:

The Challenges of Automating a Continuous Downstream Biotechnology Process

“The Challenges of Automating a Continuous Downstream Biotechnology Process,” which will examine the steps required to implement a continuous downstream platform and also the main challenges. This webinar will present a case study example highlighting a collaboration between Pall and CPI. Both parties will present, giving both supplier and end user perspectives on the implementation process.

This webcast is being offered twice:

Monday, April 29, 2019 at 08:00 AM  PDT / 11:00 AM  EDT / 04:00 PM BST / 05:00 PM CET

Thursday, May 2, 2019 08:00 AM BST / 09:00 AM CEST / 01:30 PM IST /     05:00 PM JST

Duration: 1 hour

Professional Training:

Continuous Downstream Processing

Biofactory Competence Center, Fribourg, Switzerland, May 21-23, 2019

This 3-day training course will provide an introduction to continuous down-stream processing with hands-on practical and theory in process development and bio-manufacturing. It will give an introduction to different available technologies for continuous cell-separation, ultrafiltration, diafiltration and chromatography. The principles on process-integration, quality-by-design, scale-up and economic considerations for continuous processing will be discussed.

Headlines:

“Widespread Testing Begins on Malaria Vaccine That Is Only Partly Effective,” The New York Times

“With malaria deaths rebounding worldwide, a pilot program testing a new and fiercely debated malaria vaccine began on Tuesday in Malawi. Dr. Katherine O’Brien, the World Health Organization’s director of immunization, called the rollout “a historic moment in the fight against malaria,” and said the testing will soon expand to malarious regions of Ghana and Kenya…”

“AbbVie’s Skyrizi drug to treat psoriasis wins U.S. approval,” Reuters

“AbbVie Inc said on Tuesday that the U.S. Food and Drug Administration approved its Skyrizi drug as a treatment for plaque psoriasis at a time when its blockbuster psoriasis drug, Humira, faces patent pressures. Plaque psoriasis is the most common form of psoriasis, a chronic skin condition…”

“Lilly, Avidity to Partner on Immunology Drugs in Up-to-$440M Collaboration,” Genetic Engineering News

“Eli Lilly will use the platform of Avidity Biosciences to develop new treatments in immunology—the pharma giant’s third immunology collaboration announced in the past four months—and other unspecified “select indications,” through a partnership that could generate up to $440 million-plus for the six-year-old startup, the companies said today…”

“Mustang flying high as ‘bubble boy’ gene therapy aces small study,” FierceBiotech

“They’re using the “c” word. Mustang Bio’s stock leapt more than 400% in after-hours trading Wednesday on the news that a gene therapy it licensed from St. Jude Children’s Research Hospital cured eight infants with X-linked severe combined immunodeficiency (X-SCID)—also known as “bubble boy” syndrome…”