This week’s headlines include: Gilead to separate Kite cell therapy unit, posts higher profit, Ocrevus finally available on NHS, As measles returns, U.S. states look to cut vaccine exemptions, FDA Publishes List of Priority Patient Preference Areas for Medical Devices, Pfizer gets U.S. approval for $225,000 a year heart drug, and AstraZeneca-Daiichi breast cancer treatment shows promise in latest study.

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®

BPI Digital Week

BPI Digital Week is a Complimentary Webinar Series that Focuses on the Innovative Science and Technologies Needed to Accelerate Biologics to Market

This free-to-attend webinar series features live scientific technology demonstrations presented by leading scientists and engineers working across the entire spectrum of biopharmaceutical development and production.

Get Your Complimentary Pass

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:

“Gilead to separate Kite cell therapy unit, posts higher profit,” Reuters

“Gilead Sciences Inc, which hired Roche veteran Daniel O’Day to be its new chief executive, on Thursday said Kite Pharma, the cancer-focused cell therapy company it acquired in 2017, will become a separate business unit…”

“Ocrevus finally available on NHS,” PharmaTimes Online

“After 21,000 people signed a charity petition, the first primary progressive multiple sclerosis (MS) drug has been made available on the NHS. Roche’s Ocrevus (ocrelizumab) is the first and only treatment licensed in Europe for primary progressive MS, but was initially rejected by the National Institute for Health and Care Excellence (NICE) due to being considered too expensive for the benefits it can provide…”

“As measles returns, U.S. states look to cut vaccine exemptions,” Reuters

“Maine could soon prohibit parents from citing religious or personal beliefs to avoid vaccinating their children, making the U.S. state one of a half dozen cracking down during the nations’ largest measles outbreak in 25 years…”

“FDA Publishes List of Priority Patient Preference Areas for Medical Devices,” Regulatory Focus

“The US Food and Drug Administration (FDA) on Thursday published a list of patient preference priority areas that may be useful in developing medical devices and in the agency’s assessment of those devices. “Patients are the experts in living with their disease or condition, the outcomes that are most important to them, and how they weigh benefits and risks. Through our Patient Preference Initiative, we’ve committed to seeking patient input on these types of topics to help inform our regulatory decision making,” said Center for Devices and Radiological Health (CDRH) Director Jeff Shuren.”

“Pfizer gets U.S. approval for $225,000 a year heart drug,” Reuters

“The U.S. Food and Drug Administration on Monday approved Pfizer Inc’s oral drug, tafamidis, to treat a rare and fatal heart disease called transthyretin amyloid cardiomyopathy, the U.S drugmaker said…”

“AstraZeneca-Daiichi breast cancer treatment shows promise in latest study,” Reuters

“An experimental breast cancer drug being developed by British drugmaker AstraZeneca and Japan’s Daiichi Sankyo’s met its main goal in a mid-stage study, bolstering their position in a highly competitive oncology market…”