This week’s headlines include: FDA Promises Flexibility for Stem Cell Trials, Thermo Fisher to acquire Brammer Bio in $1.7 billion deal, How Will The Failure Of Biogen’s Alzheimer’s Drug, Aducanumab, Impact R&D? Amid Acquisition Drama, Celgene Resubmits MS Drug for FDA Approval, and Bayer to team up with patient compliance start-up Pilloxa.

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

Assay Automation – A guide to understanding the key drivers and considerations

Assay automation can improve a lab’s efficiency, throughput, data quality and permit scientists more time for non-routine tasks. The level of automation for an assay workflow can be flexible with some companies choosing to automate the entire process from sample handling to analysis. In other cases, only certain steps of the workflow may be selected for automation. Often people have the perception that complex assays benefit the most from automation, however there are good reasons to automate basic, routine assay formats as well. In this article, we will look at the benefits of automating assay workflows and also the key considerations important to deciding whether automation is right for your process…

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…

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…

Ask the Expert Session:

Join our Ask the Expert session, “ELISA-like Assay Formats and the Benefits of Assay Automation.”

Bringing automation on any scale into your lab can be an intimidating prospect, especially for new users. There can be significant benefits to automating a method or process, but there are also many factors to consider and even more potential pitfalls. It is a common misconception that automation or integrated platforms have to be big, expensive and complex. There is also a common misconception that less complex assay formats don’t benefit from automation. Implementing automation can be as complex as large, walk-away high-throughput screening platforms or as simple as a plate reader and stacker, or any combination in between. Thoughtful planning and careful implementation are the two factors that determine the overall success of the process. Significant care should be taken in properly defining the scope and scale of any automation project. What do you hope to accomplish? Is it increased throughput? More consistency across assay runs? Allow scientists to focus on non-routine tasks? Automation can help provide all of these. Automating relatively simple assays that need to be done on a regular basis is a great way to free up time for scientists to focus on non-routine work while maintaining consistency across assays.

If you have questions regarding how to automate your ELISA method(s) or which method is suitable for automation, please join us for a special Ask the Expert session with Philip Gorman. Philip is the senior researcher for the High Throughput Antibody Discovery team at Boehringer Ingelheim Pharmaceuticals Inc.  He obtained his BS in Physiology and Neurobiology from the University of Connecticut and an MS degree in Biology from Southern Connecticut State University.  He has held many roles within the Pharmaceutical and Biotechnology industries with focus on application development and support for research in genetics, immunotoxicology and immunology. Within the last 17 years, Philip has gained knowledge and experience in assay development, automation and automation integration. Since 2011, he has been expanding the use of automation for antibody discovery within BI, focusing on ELISA, AlphaLISA and MSD assay formats.

Headlines:

“FDA Promises Flexibility for Stem Cell Trials,” FDA News

“Regulators are promising “flexibility” in clinical trial design for stem cell therapies for rare diseases. In a final guidance, the FDA says it “recognizes that, for regenerative medicine therapies for rare diseases, certain aspects of drug development that are feasible for common diseases may not be feasible, and that development challenges can be greater with increasing rarity of the disease.”

“Thermo Fisher to acquire Brammer Bio in $1.7 billion deal,” Reuters

“Thermo Fisher Scientific Inc, the world’s largest maker of scientific instruments, said on Sunday it has agreed to buy Brammer Bio in a roughly $1.7 billion cash deal. Brammer Bio, a viral vector manufacturer for gene and cell therapies, is expected to post $250 million in revenue for 2019, Thermo Fisher said in a statement…”

“How Will The Failure Of Biogen’s Alzheimer’s Drug, Aducanumab, Impact R&D?” Forbes

“The landscape of experimental Alzheimer’s disease (AD) drugs is strewn with failures, so much so that it has been referred to as “an unrelenting disaster zone”. Recognizing the greatly increasing number of patients with this disease, many biopharma companies have invested a lot of resources in attacking this problem, only to be turned away in late stage studies as happened to Merck with its BACE inhibitor, verubecestat, and Lilly with its beta-amyloid antibody, solanezumab…”

“Amid Acquisition Drama, Celgene Resubmits MS Drug for FDA Approval,” Xconomy

“Celgene said Monday it has again sent the FDA an application for approval of ozanimod, an experimental multiple sclerosis drug it added to its pipeline in 2015 as part of its $7.2 billion acquisition of San Diego’s Receptos…”

“Bayer to team up with patient compliance start-up Pilloxa,” PharmaTimes Online

“Swedish start-up Pilloxa has initiated a strategic partnership with Bayer AB for an innovative smart pillbox to tackle the ever-growing problem of patient compliance…”