The Dish’s Weekly Biotechnology News Wrap Up – March 15, 2019

This week’s headlines include: National Cancer Institute chief to serve as acting FDA head, FDA approves first immunotherapy regimen for breast cancer, Recent Developments in Hemophilia: Gene Therapy, Trump seeks big cuts to science funding — again, FDA approves Pfizer’s biosimilar to Roche’s Herceptin, and GE Healthcare Announces Digital Collaboration with Amgen.

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

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Increased CHO Transfection Efficiency and Production in a Straight Forward System

Transient protein production enables quick and efficient production of milligram to gram quantities of recombinant protein, which saves time and cost compared to developing a genetically stable cell line for use in bioproduction. This is particularly important in drug development where preclinical material is needed quickly in order to make informed go/no go decisions. Having access to preclinical material faster can greatly impact the overall drug development timeline. The challenge has been low transfection efficiency and productivity, particularly in CHO cells. CHO cells are typically more difficult to transfect, but are the preferred vehicle of antibody production due to their use in larger scale production of clinical material…

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…


The Down Stream Column

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…


Headlines:

“National Cancer Institute chief to serve as acting FDA head,” Reuters

“U.S. President Donald Trump’s administration has tapped National Cancer Institute Director Norman Sharpless to serve as acting commissioner for the Food and Drug Administration, following the resignation of Scott Gottlieb earlier this month. Sharpless, who has led the National Institutes of Health’s cancer unit since 2017, will take over following Gottlieb’s exit in April, the U.S. Department of Health and Human Services said on Tuesday…”

“FDA approves first immunotherapy regimen for breast cancer,” CNN

“The US Food and Drug Administration has granted its first approval to an immunotherapy regimen for breast cancer, the agency announced Friday. The treatment received accelerated approval for triple-negative breast cancer that is locally advanced or metastatic, that cannot be surgically removed and whose cells include a protein called PD-L1. It comprises a combination of immunotherapy and chemotherapy: Tecentriq and Abraxane, respectively…”

“Recent Developments in Hemophilia: Gene Therapy,” MedPage Today

“Gene therapy for hemophilia is starting to come of age and promises to transform the way patients with this rare blood disease are treated. “The concept of gene therapy has sort of been at the root of where we’ve been heading in the treatment of hemophilia from the very beginning,” Steven Pipe, MD, of the University of Michigan in Ann Arbor, told MedPage Today…”

“Trump seeks big cuts to science funding — again,” Nature

“The White House plan would give the National Institutes of Health (NIH) US$34.4 billion, roughly $5 billion below the current level. The plan would replace the the Agency for Healthcare Research and Quality (AHRQ), an independent agency in the Department of Health and Human Services, with a new NIH institute, the National Institute for Research on Safety and Quality…”

“FDA approves Pfizer’s biosimilar to Roche’s Herceptin,” Reuters

“The U.S. Food and Drug Administration said on Monday it approved Pfizer Inc’s biosimilar to Roche AG’s blockbuster breast cancer treatment Herceptin. The approval comes nearly a year after the agency declined to approve the drug, Trazimera, and sought additional technical information…”

“GE Healthcare Announces Digital Collaboration with Amgen,” Pharmaceutical Technology

“In a March 11, 2019 press release, GE Healthcare announced a digital data exchange collaboration program with Amgen, which will include advanced data analytics to increase the understanding of the relationship between raw material variability and process performance during the manufacture of biologic medicines. As a part of this initiative, GE Healthcare and Amgen will be installing a seamless connection for data transfer between GE Healthcare raw material manufacturing sites and Amgen’s process development center in Cambridge, MA…”