The Dish’s Weekly Biotechnology News Wrap Up – September 20, 2019

This week’s headlines include: Speaker Nancy Pelosi Unveils Plan To Lower Prescription Drug Costs, Merck’s Ebola vaccine tees up FDA date, aiming for first status, FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development, Aimmune’s Peanut Allergy Drug Wins Broad FDA Panel Backing, and Microbiome Affected by Babies’ Delivery Method, but Long-Term Effects Remain Unknown.

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

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New Flexible Bispecific Antibody Format Demonstrates Improved Therapeutic Properties and Manufacturability

This year’s Next Generation Protein Therapeutics & Bioconjugates™ Summit held in San Francisco provided an in-depth look at the latest developments in next-generation protein therapeutic discovery and manufacturing. One talk that I found of particular interest was, “WuXiBody,™ an Innovative and Versatile Bispecific Antibody Format, Opens a New Era For Therapeutic Antibody Development,” presented by George Wang, Ph.D., MBA, Vice President of Biologics Discovery, WuXi Biologics. The talk provided an excellent overview of the promise of bispecific antibodies as well as the associated challenges. Dr. Wang also shared an innovative bispecific antibody platform designed to address many current platform shortcomings…

Using transposases to generate clones with high, predictable expression and stability

Standard cell line development workflows include transfection followed by the screening of hundreds to thousands of clones, in an effort to find high producing clonal colonies that are stable and demonstrate specific attributes based on the product specifications. Some approaches at the clone isolation stage utilize in-situ fluorescence detection to try and pull out up front the best protein secretors. I am pleased to share the following guest blog that presents an alternative solution to ensure isolation of the high producing clones – transposases. I was fortunate enough to be able to interview the author about his article and have provided the transcript of our conversation following the guest blog…

Cool Tool – Vivaflow Crossflow Cassettes provide plug and play target molecule concentration systems that are scalable for a wide range of sample volumes

Ultrafiltration is an important function in many labs. While there are many ways to conduct concentration and filtration, it is critical that you select the appropriate method for target recovery and sample volume, while still considering speed and efficiency. Sartorius has launched its Vivaflow Crossflow Cassettes with these requirements in mind. With three products specifically designed to meet different customer requirements, they provide a simple to use, plug and play system for concentrating a wide range of sample types, over volumes from 0.1 liter to 5 liters, with high reliability and consistency of results…

Improved Protein yields in CHO and HEK293 cells using a dedicated transfection reagent: FectoPRO®

Transient gene expression (TGE) is commonly used for medium scale production of recombinant proteins and antibodies. This approach allows generation of sufficient protein amounts without an investment in production of stable cell lines prior to “proof of concept” studies or tools validation. The speed and flexibility of the process has enabled TGE to be widely adopted in bioproduction for early discovery, research applications and process development…

Antibody Drug Conjugate (ADC) Development and Manufacturing Challenges and Solutions

In this podcast, we interviewed Dr. J.J. Luo, Executive Director and Dr. Lily Yin, Head of Biologics Conjugation Development, at WuXi Biologics about the state of the ADC marketplace and the challenges in developing antibody drug conjugates. We then dove into reasons behind why they built a dedicated manufacturing facility for ADCs and other bioconjugates and how a single-source development platform can benefit bioconjugate drug development efforts…


The Down Stream Column

Supplier Qualification and Material Selection – A Case Study of Biopharmaceutical Resin Manufacture

To ensure a safe and continuous supply of life-saving biopharmaceuticals, raw materials for biomanufacturing must be selected carefully and suppliers evaluated with much scrutiny. Several instances of drug shortages as the result of either a raw material shortage or contamination reinforce the need for thorough evaluation. Ensuring a reliable supply and the quality of the materials selected is of paramount importance…

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…


Conferences:

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…

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Headlines:

“Speaker Nancy Pelosi Unveils Plan To Lower Prescription Drug Costs,” National Public Radio

“House Speaker Nancy Pelosi, D-Calif., unveiled her long-anticipated plan to lower the cost of prescription drugs on Thursday. It is a priority shared by President Trump, fueling a glimmer of hope that there is a deal to be had on the issue ahead of the 2020 elections…”

“Merck’s Ebola vaccine tees up FDA date, aiming for first status,” Fierce Biotech

“The FDA has accepted an application for approval of Merck’s Ebola vaccine V920. Merck will learn whether the FDA will approve V920 by mid-March, giving it a shot at becoming the first company to receive clearance to sell a vaccine against the virus in the U.S…”

“FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development,” Regulatory Focus

“The US Food and Drug Administration (FDA) on Monday released 53 product-specific guidance documents to aid generic drug development, including 34 new guidance documents, 26 guidances for treatments that lack generic competition and 16 for complex products…”

“Aimmune’s Peanut Allergy Drug Wins Broad FDA Panel Backing,” Bloomberg

“An advisory panel to the U.S. Food and Drug Administration voted in favor of Aimmune Therapeutics Inc.’s Palforzia to treat kids with peanut allergies. Seven of the nine panelists voted that Palforzia is an effective therapy that warrants U.S. approval, while eight of them agreed that it’s safe enough for patients to use…”

“Microbiome Affected by Babies’ Delivery Method, but Long-Term Effects Remain Unknown,” Genetic Engineering News

“The role of delivery method on the acquisition of a newborn’s gut microbiome has been an ongoing, controversial topic. Although vaginal and cesarean section deliveries have been previously shown to result in differences, the significance between the two in infancy, into childhood and beyond, has not been established…”