The Dish’s Weekly Biotechnology News Wrap Up – June 9, 2017

By on June 9, 2017

This week’s headlines include: Novartis, IBM Watson Health team up for breast cancer project, Drug Prices Become Target for FDA as Chief Expands Purview, F-star, Merck Agree Up to €1B Deal to Develop Five Bispecific Anticancer Antibodies, User fee Reauthorization Bill Advances in the House, NICE backs Keytruda for first and second-line use, and Cancer Drug Proves to Be Effective Against Multiple Tumors.

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

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We’re Heading to ISSCR 2017 Next Week – Are you? Don’t miss these great talks and activities

ISSCR’s Annual Meeting begins June 13th in Boston. The ISSCR Annual Meeting is “a place where breakthrough science, global collaboration, and researchers across the breath of the field come together. The ISSCR Annual Meeting offers the best opportunity to collaborate with leaders and peers from around the world to fully realize the promise of our field in therapies, treatments, and clinical advances.” Cell Culture Dish will be attending and blogging from the event. Please don’t miss our ISSCR related blogs over the upcoming months. If you are attending, don’t miss these exciting talks and activities!…

Cool Tool – A single cell dispensing unit for cell line development – taking the benefits of Limiting Dilution and combining with high seeding efficiencies

One of the most popular traditional cloning techniques is limiting dilution. The technique is cost-effective and has received regulatory acceptance for several years. In limiting dilution cloning, a mixed population of cells is diluted in liquid media and is dispersed into 96-well plates or other culture vessels. The goal of this method is to isolate individual cells into single wells or vessels. In order to accomplish this, the wells are seeded at an average density of less than one cell per well. While low seeding density increases the chance of isolating single cells into single wells, it also means that there will be more empty wells. Empty wells represent a waste of personnel time, consumables and lab space. Nonetheless, no matter how low the seeding density, some wells will still contain multiple cells or doublets. While the limited dilution method is still very popular, it is time consuming and labor intensive. With advancements in cell line development and successful alternatives available, many groups are looking to replace limiting dilution with more advanced and robust technologies…

Cool Tool – Find the resources you need to get started with organoids at the Organoid Information Hub

The development of organoid culture systems has provided researchers with a highly physiologically relevant system for studying stem cell biology, organ development, tissue homeostasis, and disease pathology. By mimicking the structures found in the organ, as well as maintaining multiple organotypic cell types, organoids have become valuable tools in modeling in vivo biology….

Cool Tool – Shape Matters – An Innovative Design for Single-use Bioreactors

For many years cylindrical stainless steel tanks have been used in biopharmaceutical production. The primary reason for the cylindrical shape was that it provided the mechanical stability required for high-pressure steam sterilization…


The Down Stream Column

Subvisible Particle Characterization: Why Simply Counting Shadows Leaves You in the Dark

Significant advances in analytical technology over the past few years have improved the quantification and characterization capabilities for subvisible ( 1 – 100 µm) and submicron particles (≤1 µm). As the technology continues to improve so do the expectations of regulatory agencies for sponsors to characterize particles in these size ranges. However, multiple orthogonal methods are required to span the entire range and accurately characterize the particle profile. Each instrument has its own limitations based on detection method and properties of therapeutic protein products that must be well understood to generate high quality data. KBI Biopharma has extensive experience with particle detection methods, as well as, in-depth particle data analysis. KBI’s Particle Characterization Core team can help choose appropriate orthogonal particle to combine in order to accurately quantify, characterize and identify particles in specific therapeutic protein products for all size ranges based on clients’ needs

Optimize Changeover Workflows with ÄKTA readyflux – An Automated, Single-use Crossflow Filtration System

Multiple buffers in a wide range of formulations are required to produce a single biopharmaceutical. Because of the large volumes required, buffer preparation can easily become a bottleneck in production. Traditionally, buffers are prepared manually in the volume needed according to specific recipes. Due to the large quantities used, buffer management requires careful planning and considerable floor space is required for the preparation and storage of such large buffer quantities. In addition to high labor and facility space cost, there is a risk of human error and variability associated with such a time-intensive manual activity. Buffer variability can affect both quantity and quality of the final product…

Cool Tools – Pre-activated Resins for Ligand Immobilization to facilitate the Creation of Customized Affinity Purification Media

In the development of biopharmaceuticals there are times when an off the shelf affinity chromatography medium is unavailable or isn’t highly selective for the target molecule being purified. It is possible then to design a custom chromatography solution by coupling a specific ligand to a pre-activated resin…

Cost and impact of a bioburden incident

Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks. Making monoclonal antibody (mAb) drugs? Safety first. In releasing a biomedicine, the last thing a biopharma company wants is for people to be harmed. This makes the risk of bioburden, and how it can be prevented, a major issue for drug safety…

Webinars:

Continuous Bioprocessing Technology and Regulatory Considerations

Wednesday, June 14, 2017, 01:00 PM EDT

SUMMARY

Many industries have adopted a one-piece flow approach (continuous manufacturing) to leverage the core reductions in inventory, increased operational flexibility, and greater product consistency and quality that it delivers. However, biopharmaceutical manufacturers have been slow to put continuous processing theory into practice due to the highly-regulated nature of the industry.

On June 14th at 1pm EDT, Peter Levison, PhD will moderate as Mani Krishnan, PhD and Marc Bisschops, PhD examine the evolution of interest in continuous bioprocessing, the advances being made in today’s market, and how the regulatory authorities are responding. Mani will also offer insight into the technological challenges of implementing continuous bioprocesses, and potential regulatory questions surrounding batch definition, bioburden control, virus clearance, scale-up/down, defect perturbation, design space, etc.; he will also propose effective mitigation strategies for a successful transition to continuous bioprocessing.

Registration for the Americas

Registration for Europe/Asia

SUMMARY

Continuous multi-column chromatography (MCC) has been gaining increasing interest as an enabling bioprocessing technique that allows for increases in specific productivity (g/L/hr) and operating binding capacity (g mAb/L sorbent) over traditional batch solutions. With recent advances, users have reported an increase in cost savings stemming from reduced resin volumes, lower buffer consumption, and increased resin usage.

Mark Pagkaliwangan presents on July 18th at 1PM EDT, with David Johnson moderating, as they discuss MCC solution advances with processes utilizing two columns or more. They will explore how the total number of columns used in a process can affect performance, and how titer and flowrate can be optimized with more columns for greater efficiency and productivity.

Registration for the Americas

Registration for Europe/Asia

Cell Culture Events:

Cell Culture & Cell Therapy: Bioprocessing Conference – June 26-27, 2017, Philadelphia

MarketsandMarkets put together a unique platform to establish the reproducible and robust manufacturing processes for the production of stable cell culture and therapeutic cells. At the Cell Culture & Cell Therapy: Bioprocessing Conference scheduled to be held in Philadelphia, USA on 26 – 27 June 2017, leading experts in the industry will be gathered to discuss strategies, technologies and innovations in the area of bioprocessing of cell culture and cell-gene therapies.

Headlines:

“Novartis, IBM Watson Health team up for breast cancer project,” Reuters

“Novartis has agreed to work with IBM Watson Health to explore ways to use patient data and advanced analysis to glean insights on the likely outcomes of breast cancer treatments, the Swiss drugmaker said on Monday…”

“Drug Prices Become Target for FDA as Chief Expands Purview,” Bloomberg

“The head of the U.S. Food and Drug Administration is considering using the agency’s powers to bring more price competition to the market for generic drugs, targeting high-priced products by prioritizing the approval of additional competing treatments…”

“F-star, Merck Agree Up to €1B Deal to Develop Five Bispecific Anticancer Antibodies,” Genetic Engineering News

“U.K.-based F-star and Germany’s Merck established a potentially €1 billion (approximately $1.13 billion) strategic collaboration to develop and commercialize five of F-star’s bispecific immuno-oncology antibodies (mAb2™). The deal includes F-star’s lead preclinical asset FS118, which targets lymphocyte activation gene 3 (LAG-3) and programmed death-ligand 1 (PD-L1), plus four additional bispecific antibodies selected by Merck from F-star’s platform…”

“User fee Reauthorization Bill Advances in the House,” Regulatory Focus

“The House Energy and Commerce Committee on Wednesday voted unanimously (54-0) to advance its bill to reauthorize the US Food and Drug Administration’s (FDA) user fee programs for prescription and generic drugs, biosimilars and medical devices to the full House…”

“NICE backs Keytruda for first and second-line use,” PharmaTimes

“MSD’s Keytruda has now become the first and only immunotherapy to be recommended by the National Institute for Health and Care Excellence as a first and second line treatment for specific populations of patients with lung cancer…”

“Cancer Drug Proves to Be Effective Against Multiple Tumors,” The New York Times

“The 86 cancer patients were a disparate group, with tumors of the pancreas, prostate, uterus or bone. One woman had a cancer so rare there were no tested treatments. She was told to get her affairs in order. Still, these patients had a few things in common. All had advanced disease that had resisted every standard treatment. All carried genetic mutations that disrupted the ability of cells to fix damaged DNA. And all were enrolled in a trial of a drug that helps the immune system attack tumors…”

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