This week’s headlines include: Sanofi wins U.S. approval to sell dengue vaccine but with major restrictions, Gene Therapy May Help Fight Tough-to-Treat Blood Cancer, StemBioSys Expanding Applications of Platform Technology with Two Federally Funded Grants, Regeneron Licenses Calixar’s Membrane Protein Stabilization Technology, FDA Approves 19th Biosimilar, 2nd for Enbrel, and GSK dumps universal flu vaccine after interim data readout.

Podcasts:

Check out our podcast channel. We have over 25 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:

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…

Conference:

Vaccines Development Day

Thursday, May 16, 2019 from 9:00 AM to 5:00 PM EDT, BWI Aiport Marriott – Baltimore, MD

Cell Culture Technology

Scalability, perfusion and vaccine solutions

Complimentary workshop hosted by Eppendorf to discuss the latest developments in upstream bioprocessing methods.

Presenter topics include:

• Insights on vaccine development and current technology
• Studies illustrating cell culture scale-up including lentiviral vectors and rAAVs
• Various techniques of high density perfusion cell culture
• Techniques for scaling bench to production
• Small-scale perfusion using an ATF cell retention device with parallel bioreactor system
• Advancing viral vector and vaccine process characterization with adherent cells using an integrated perfusion platform presented by Corning
• Simplify and intensify cell culture with XCell™ ATF presented by Repligen®

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.

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:

“Sanofi wins U.S. approval to sell dengue vaccine but with major restrictions,” Reuters

“The U.S. Food and Drug Administration on Wednesday gave Sanofi SA’s dengue vaccine Dengvaxia a very narrow approval as the company continues to suffer from evidence that its vaccine, which took 20 years to develop, can cause severe infections in some people…”

“Gene Therapy May Help Fight Tough-to-Treat Blood Cancer,” Health Day

“A gene therapy that tweaks the immune system might offer hope to people with blood cancer that has resisted standard treatments, a new preliminary trial suggests. The cancer, called multiple myeloma, arises in certain white blood cells. It is currently incurable, but there are treatments that can help people live with the disease for years. However, most people eventually progress, and some fail to respond to the available therapies at all…”

“StemBioSys Expanding Applications of Platform Technology with Two Federally Funded Grants”

“StemBioSys Inc. has announced that they are working on two projects that are being funded from separate successful Small Business Innovative Research (SBIR) grant applications. The first study is a Phase I SBIR grant titled “Expansion of “youthful” mesenchymal stem cells from elderly individuals for autologous cell-based therapies”, and is being funded by the National Institutes of Health (NIH), National Institute On Aging. This work is an extension of graduate dissertation research performed in the laboratory of the Company’s scientific founder, Dr. Xiao-Dong Chen, by Travis Block, Ph.D. (Sr Scientist at StemBioSys). Dr. Block explains that the aims of this project are to further develop methods for selective isolation and expansion of healthy, “youthful” stem cells from a diminished population of stem cells found in elderly individuals and to characterize their potential to treat age-related diseases…”

“Regeneron Licenses Calixar’s Membrane Protein Stabilization Technology,” Genetic Engineering News

“Regeneron Pharmaceuticals has acquired exclusive licensing rights to the native membrane protein stabilization technology of Calixar, the French biotech said today, through a collaboration whose value was not disclosed. The companies plan to conduct research and discovery of antibodies against an undisclosed target in various unspecified therapeutic fields, Calixar said…”

“FDA Approves 19th Biosimilar, 2nd for Enbrel,” Regulatory Focus

“Samsung Bioepis confirmed to Focus via email Friday that the company’s biosimilar to Amgen’s Enbrel (etanercept), to be known as Eticovo (etanercept-ykro), has been approved by the US Food and Drug Administration (FDA). This is the second US approval of an Enbrel biosimilar, with the first coming in August 2016 for Sandoz’s Erelzi (etanercept-szzs), although Erelzi has yet to launch. In the EU, however, both Sandoz and Biogen/Samsung have successfully launched their Enbrel biosimilars (more on the sales below)…”

“GSK dumps universal flu vaccine after interim data readout,” Fierce Biotech

“GlaxoSmithKline has dumped a universal flu vaccine after getting a look at interim phase 1 data. The clinical data and other results persuaded GSK to stop development of the candidate once it finishes the ongoing study. The influenza vaccine, GSK3816302A, combines the Icahn School of Medicine Mount Sinai’s (ISMMS) chimeric hemagglutinin (cHA) technology and GSK’s AS03 adjuvant in a bid to develop a shot that protects against all current and future circulating influenza strains, thereby eliminating the need to develop new jabs and administer them each year…”