The Dish’s Weekly Biotechnology News – June 21, 2019

This week’s headlines include: Uganda clears three experimental Ebola treatments, watches for spread, Bluebird Bio Sets $1.8M Price on Gene Therapy for Rare Blood Disease, Amgen unveils five-year survival data for Blincyto, French drugmaker Sanofi, Google to use data tech for innovations, and Thermo Fisher’s Brammer Bio Completing $100M in Expansion Projects.

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

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Advanced CHO Transient Expression System Provides Increased Productivity and Efficiency

Transient transfection has been used for years to quickly and cost-effectively manufacture recombinant protein. The advantage of using transient transfection is that it takes significantly less time to produce proteins when compared with the alternative of developing a genetically stable cell line. Today’s need for protein early in drug development necessitates short turnaround times for production, resulting in demands for improved efficiency and productivity…

Innovative vaccine manufacturing enables the delivery of vaccines to the developing world

In this podcast and accompanying article, we interviewed Dr. Alex Chatel, Product Manager, Viral Applications, Univercells about the biggest challenges facing vaccine manufacturing today, why it is so difficult to manufacture and deliver vaccines to the developing world and how a novel technology with the support of the Gates Foundation is poised to address these challenges…

Innovative Chemicals for Process Intensification in Cell Culture Media

L-Tyrosine is a key amino acid for both cellular metabolism and protein synthesis and its depletion in fed-batch processes has been correlated with a drop in specific productivity1 and with protein sequence variants.2 This critical amino acid presents an extremely low solubility, especially at neutral pH.3,4 The use of tyrosine di-sodium salt concentrations above 1 g/L in feeds induces precipitation and increases the risk of media instability, mainly through co-precipitation of other amino acids. This may lead to sub-optimal performance due to insufficient supply of nutrients and finally to low performing processes…

Optimising outgrowth of clones following single cell cloning ensures more predictable and effective cell line development

Successful cell line development is critical to effective CHO cell based biomanufacturing. To accomplish this, companies must identify cell lines that have good manufacturing potential via clone selection. Clones that warrant further investigation are those that are stable, good producers, demonstrating specific attributes based on the product specifications. In order to select the best cell lines, companies must generate a good number of clones for screening…

Novel Acoustic Platform Provides Gentler, More Efficient Solution for Cell Processing

Cell and gene therapies are in need of evolving manufacturing technologies to move products from research, through development and into, commercial manufacturing. As more cell and gene therapy products achieve clinical success, more investments are being made in creating manufacturing technologies to support the industry. There are several advancements in this area including the closing and automating of many manufacturing processes and increasing efficiencies with the creation of fit for purpose equipment and consumables. There are still, however, many needed improvements to further increase productivity and reduce cost…


The Down Stream Column

Bioburden Control Strategies for Continuous Downstream Processing

Implementing continuous bioprocessing for biomanufacturing has been increasing in interest. As a result, questions have arisen about the implementation of this strategy for downstream processes. Of particular interest is maintaining a high degree of bioburden control in continuous downstream process. While bioburden control strategies for continuous processing focus on prevention, not unlike batch processing, many want to know if there are specific strategies that should be implemented with continuous bioprocessing that are different than those used in batch processing…

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…


Conferences:

Driving Value Through Intensified Bioprocessing

June 26June 28
Lady Margaret Hall, University of Oxford, Norham Gardens,
Oxford,unitedOX2 6QAUnited Kingdom
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Driving Value Through Intensified Bioprocessing

Attendees will benefit from learning about the current state-of-the-art advancements in continuous manufacturing and also learn about the successful organizations that are developing these methods in-house through the industrial case studies and workshops. Together we will drive change, innovate growth and pioneer smarter technologies to ensure they reach their full potential.

Find out more »

World ADC San Diego

October 8October 11
Grand Hyatt San Diego, 1 Market Place
San Diego,CA92101United States
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World ADC San Diego

With the next ADC approval in touching distance, the ADC field is on the edge of their seats to hear when the next exciting announcement will be. With new collaborations and important results constantly being shared, it’s safe to say the field is ever-evolving. However, despite the excitement we continue to face roadblocks with off-target toxicity, ensuring a robust supply chain and maximizing the clinical therapeutic window of an ADCs. Designed with Pfizer, Seattle Genetics, Genentech and ImmunoGen this leading…

Find out more »

Headlines:

“Uganda clears three experimental Ebola treatments, watches for spread,” Reuters

“Health workers have got the all-clear to use three experimental Ebola treatments in Uganda, a week after the deadly disease spread over the border from Democratic Republic of Congo, authorities said on Tuesday. Two people who had travelled from Congo died in Uganda last week, the World Health Organization said. A three-year-old boy who was sent back to Congo after testing positive for the disease died at the weekend, Congo’s health ministry said…”

“Bluebird Bio Sets $1.8M Price on Gene Therapy for Rare Blood Disease,” Xconomy

“The latest price tag for a gene therapy, a treatment meant to provide a long-lasting effect with a single dose, is now set. The treatment, Zynteglo, developed for the rare blood disease beta thalassemia, will cost roughly $1.8 million…”

“Amgen unveils five-year survival data for Blincyto,” PharmaTimes

“Amgen has revealed “compelling” long-term survival data for its acute lymphoblastic leukemia (ALL) drug Blincyto (blinatumomab). The five-year overall survival (OS) analysis – based on data from the Phase II BLAST study, which included patients with minimal residual disease (MRD)-positive ALL – found the median OS for Blincyto-treated patients to be 36.5 months at a median follow-up of 59.8 months…”

“French drugmaker Sanofi, Google to use data tech for innovations,” Reuters

“French healthcare company Sanofi has teamed up with Google to work on innovations, aimed at using emerging data technologies to change how medicines and health services will be delivered in future. Sanofi and Google will use data sets to improve their understanding of key diseases and extract patients’ insights and feedback, the companies said in a joint statement…”

“Thermo Fisher’s Brammer Bio Completing $100M in Expansion Projects,” Genetic Engineering News

“Thermo Fisher Scientific says its recently-acquired Brammer Bio is completing $100 million in capital expansion projects, as the viral vector contract development and manufacturing organization (CDMO) looks to satisfy growing demand for gene therapies for clinical and commercial use. In Alachua, FL, Brammer has added new quality control laboratories, and later this year will bring on an additional process development laboratory and expanded warehouse capacity…”