The Dish’s Weekly Biotechnology News Wrap Up – March 1, 2019

This week’s headlines include: Roche to pay $4.3bn for Spark in gene therapy move, Merck to Acquire Immune Design for $300M, Boosting Immunotherapy Vaccine Pipeline, Pfizer switches RA patients to lower dose of fast-growing Xeljanz as safety issues arise in postmarketing study, This San Diego Ebola drug is heading to the Congo. Can it be tested during civil war? and Pluristem’s cell therapies head for orbit with NASA deal.

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

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Keys to successful single-use bioreactor scale up – from small scale to pilot scale

Successful monoclonal antibody (mAb) manufacturing relies on good process development and reliable bioreactor scale up. Initial process development work is typically conducted at small scale, then moved to bench scale and lastly to pilot scale before moving into manufacturing. One of the biggest challenges is scaling up an optimized process from process development to manufacturing scale. Just a small change in the size of the bioreactor can have a cascade effect on many other culture conditions…

Cool Tool – New chemical modification of L-Tyrosine and L-Cysteine increase solubility and stability and permit single feed strategies

A long-standing challenge in the use of amino acids as part of a feed strategy has been the insolubility of tyrosine and the oxidation of cysteine at neutral pH. This has required the use of alkaline feeds to allow solubility and stability. The need for alkaline feeds complicates operations by forcing a multiple feed strategy as all components can’t be fed together…

Enzymes for Cellular Lysis or Protoplast Formation: Bacteria, Yeasts, and Plant

Digesting cell walls using enzymes is a critical component of many scientific approaches such as cellular lysis, proto/spheroplast formation, and numerous other approaches. The use of enzymes has advantages over physical or chemical methods because of its specificity, the use of milder conditions and lower shear stress. Since cell walls differ in composition between types of cells, it is important to use an enzyme with the correct specificity and activity for the application. Other consideration in choosing an enzyme include the purity and need for other reagents or additional procedures related to the use of that particular enzyme…

Integrating bioprocessing steps to improve efficiency and reduce cost

In this podcast, we interviewed Dr. Rick Morris, Senior Vice President, R&D, Biotech, Pall Life Sciences, about integrating bioprocessing steps to improve efficiency, reduce cost and address current challenges in the industry.  Specifically we looked at how upstream and downstream can be more integrated and how to increase integration in existing facilities…

Cool Tool – Advanced Bioprocess Controller Puts Cell Culture on Autopilot

Bioprocess controllers are an important part of a bioprocess lab. In many bioprocess labs several experiments are running simultaneously sometimes using multiple cell types with different modes and at varying scale. A bioprocess controller can help to simplify these demands, provided that the controller isn’t overly complex or challenging to operate. The goal is finding a bioprocess controller that permits maximum flexibility while still being straightforward and simple to use…


The Down Stream Column

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…

High Throughput Process Development in Biomanufacturing – Current Challenges and Benefits

Process development is and has always been a key component in successful scale-up of bioprocesses to commercial manufacture scale. At the Fourth High Throughput Process Development Conference in Toledo, Spain, several methods for high throughput process development were discussed for both upstream and downstream applications. Challenges and benefits were described along with ideas on where the industry can go from here. The proceedings were collected in a recently published report, “HTPD – High Throughput Process Development,” and include extended abstracts of talks presented at the conference. The report is very informative and I have summarized some key areas of focus in this article. We were also fortunate to be able to interview one of the conference chairs, Mats Gruvegard, GE Healthcare Life Sciences about what he saw as key takeaways from the conference and where he sees the future of high throughput process development heading…


Webinars:

Streamline Your Protein Purification Platform

In this webinar, the benefits of Pall’s chromatography process, which features KANEKA KanCapA, Mustang® Q and CMM HyperCel™ sorbents will be presented with a focus on the specificity of CMM HyperCel sorbent versus traditional cation exchangers or other mixed mode resins. This three-step process can be operated without any need for diafiltration or dilution between the chromatography steps.

Tuesday, March 5th 2019 at 8:00am PST /11:00 am EST / 4:00 pm GMT / 5:00 pm CET

Tuesday, March 12th 2019 at 8:00am GMT /9:00 am CET / 1:30 pm IST / 5:00 pm JST

Register Here


Conferences:

Americas Antibody Congress 2019

March 3March 5
Grand Hyatt San Diego, 1 Market Place
San Diego,CA 92101United States
+ Google Map
Americas Antibody Congress 2019

In the 14 years that the European Antibody Congress has run in Basel, Switzerland, there have been countless breakthroughs, advancements and achievements that not only were showcased for the first time at the European Antibody Congress but were also born out of collaborations and partnerships that were catalysed by, or initiated, at the European Antibody Congress. This is why we are launching the Americas Antibody Congress in San Diego this March to bring the amazing antibody work we’ve been showcasing…

Find out more »

BioProcess International West

March 11-14, 2019
Santa Clara Convention Center, Santa Clara, California, USA

BioProcess International US West

Overcome Your Upstream and Downstream Challenges at BPI US West 2019

Meet the global CMOs, CROs, suppliers and technology leaders who can accelerate your biological products to market by getting your 2-day exhibit hall pass to BioProcess International US West, held March 11-12, 2019 at the Santa Clara Convention Center in California.  Passes start at $399, but readers of Cell Culture Dish can save 50% on an exhibit hall pass when you register with VIP Code DISH50 by March 1, 2019 (new registrations only).  For full details and to register, visit https://lifesciences.knect365.com/bpi-west/exhibit-hall-pass?vip_code=DISH50&utm_source=cell-culture-dish&utm_medium=website


Headlines:

“Roche to pay $4.3bn for Spark in gene therapy move,” PharmaTimes Online

“Roche has announced plans to enter into a definitive merger agreement to acquire Spark Therapeutics, a leader in discovering, developing and delivering gene therapies with one commercial asset and four programmes currently in clinical trials…”

“Merck to Acquire Immune Design for $300M, Boosting Immunotherapy Vaccine Pipeline,” Genetic Engineering News

“Merck & Co. said today it has agreed to acquire Immune Design for approximately $300 million, in a deal designed to boost the buyer’s vaccine pipeline and tech capabilities through a company that eliminated 18% of its workforce and named a new lead candidate late last year after its previous lead failed a clinical trial…”

“Pfizer switches RA patients to lower dose of fast-growing Xeljanz as safety issues arise in postmarketing study,” FiercePharma

“Pfizer has been battling it out against rivals in arthritis and ulcerative colitis with its Xeljanz, and its drug has been posting big sales gains. But in a surprise disclosure, the company outlined safety concerns for a higher dose of the drug noticed by an independent board in a postmarketing study…”

 

“This San Diego Ebola drug is heading to the Congo. Can it be tested during civil war?” San Diego Union Tribune

“As the fast-moving Ebola virus sweeps through eastern Congo, scientists are braving into war zones hoping to test new medicines — including one designed in San Diego — in sick patients there. Despite civil unrest in the region, Doctors Without Borders has set up testing sites in the cities of Butembo and Beni, the latest hotspots of the current Ebola outbreak in the Democratic Republic of the Congo. But researchers have plans to chase the virus as it moves throughout the region, which it does at a rather rapid pace…”

“Pluristem’s cell therapies head for orbit with NASA deal,” FierceBiotech

“Pluristem has just reached a stellar deal with NASA that will see its cell therapies tested against the health problems caused by spending time in space. The Israeli biotech is teaming up with NASA’s Ames Research Center for the project, which will focus on using its PLX placenta-derived cell therapies to try to prevent or treat medical conditions that can occur during and after space missions, including conditions that affect the blood, bone, muscle, brain and heart…”