This week’s headlines include: Is Crispr the Next Antibiotic?, Danaher Selling Off Some Businesses to Sartorius for $750M, Tying the Deal to GE Biopharma Acquisition, NIH and Gates Foundation launch effort to bring genetic cures for HIV, sickle cell disease to world’s poor, Ex-FDA chief Gottlieb sees investment opportunity in ‘unloved’ antibiotics, and FDA Floats Idea of a Rating System for Drug Manufacturers.

Podcasts:

Check out our podcast channel. We have over 30 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:

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

Live Cell Analysis for Neuroscience Research

In this podcast, we talk with Susana Alcantara, Senior R&D Scientist and Neuroscience Program Leader, BioAnalytics, Sartorius about the ways real-time live cell analysis is enabling neuroscience research. We also discussed how real-time cell analysis can be used in neurological disease model development and in studying disease pathology to enable drug discovery…

Spheroid Culture Advancements – Microplates

While the benefits of 3D spheroids are clear, culturing them can be challenging and can give rise to the need for troubleshooting and questions. For this week’s Ask the Expert session, we are happy to have Hilary Sherman, Senior Scientist and Audrey Bergeron, Applications Scientist both with Corning Life Sciences to answer questions about culturing spheroids and the latest advancements including new plate options…

Ultrafiltration for Protein Concentration – Centrifuge and Crossflow Solutions

We recently finished our Ask the Expert discussion on “Laboratory based therapeutic and diagnostic marker protein concentration through centrifugal and crossflow ultrafiltration”. Ultrafiltration is an important tool in concentrating therapeutic and diagnostic marker proteins. Efficacy of ultrafiltration processes can be very application dependent and thus may raise technical questions in process planning. Two of the primary methods are using centrifugation or crossflow ultrafiltration. When considering the ultrafiltration method that is best for your application, it is critical that you select the appropriate method for target recovery and sample volume, while still considering speed and efficiency. During this Ask the Expert session, we covered topics related to ultrafiltration of large sample volume concentration, sensitive proteins and protein degradation, when to use cassettes vs. centrifuge, viral vector concentration, membrane selection and non-protein concentrations…

Raw Material Quality – Identifying and Mitigating Variation

In this podcast, we interviewed Cory Card, Principal Scientist Life Sciences, GE Healthcare about raw material quality, its impact on cell culture and technologies to identify and mitigate raw material variation…

Ask the Expert – Laboratory based therapeutic and diagnostic marker protein concentration through centrifugal and crossflow ultrafiltration

Efficacy of ultrafiltration processes can be very application dependent and thus may raise technical questions in process planning. To answer these questions, this week we are excited to have Rik McRae, Technical Manager for Operations, Sartorius Stedim Lab, Ltd. as our expert. Rick has over 20 years of experience in product and application research and development, production engineering and technical guidance and is currently a member of the Sartorius lab ultrafiltration team. Rik is a subject matter expert for technical support and application knowledge, with strong expertise in therapeutic protein, drug delivery nanoparticle, and diagnostic marker concentration applications, with centrifugal, pressure driven and lab scale tangential flow filtration systems…

Novel affinity resins enabling the purification of next generation antibody fragments: KANEKA KanCap™ G and KanCap™ L

Ever since the licensing of first monoclonal antibody (mAb) drug, biologics have seen unprecedented growth as drugs to treat a variety of malignancies¹. The modular structure of mAbs have allowed protein engineers to create smaller, nimbler, and multispecific next-generation antibody therapeutics. Some of these modalities can be easily produced using microbial expression systems, offering higher yields and excellent process economy²…

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…

Trainings:

Eppendorf Bioprocess Workshop

Implementation of an Affordable and Scalable Manufacturing Strategy for Gene Therapy
Upstream bioprocess development is an integral part of gene therapy product development. Cell culture bioprocess development is usually carried out at small working volumes. This helps save time and resources, because several experiments can be conducted in parallel, costs for media are kept low, and relatively little laboratory space is required. When more material is needed for characterization, trial runs, and finally for commercialization, biopharmaceutical companies transition the process to bench scale and then up to pilot or production scale. In this presentation, we will present bioprocess solutions for parallel process development at small scale. Furthermore, we will discuss bioreactor scalability and address several scaling approaches.

A Beginner’s Guide to Bioprocess Modes – Batch, Fed-Batch, and Continuous Processing
We will discuss the differences between batch, fed-batch, and continuous fermentation and how these influence culture growth. As an example, we look at E. coli fermentation processes at bench scale. We track the biomass and nutrient concentrations during batch, fed-batch, and continuous fermentation runs. We explain different methods to analyze the process, including determination of biomass, growth rate, productivity, yield, and analysis of process costs. The  comparisons can help bioprocess engineers to select the most appropriate method to meet their needs.  In our examples we studied E. coli fermentation at bench scale. The principles may also apply to bioprocesses using other microbes or mammalian cells, at both smaller and larger scales.

BTEC, NC – Wednesday, November 6, 2019 – Click here for information on North Carolina workshop

Conferences:

Headlines:

“Is Crispr the Next Antibiotic?” The New York Times

“In nature, the gene-editing tool Crispr protects bacteria against viruses. Now it’s being harnessed in the fight against superbugs and the flu…”

“Danaher Selling Off Some Businesses to Sartorius for $750M, Tying the Deal to GE Biopharma Acquisition,” Genetic Engineering News

“Danaher has agreed to sell three of its life sciences tools businesses to Sartorius Stedim Biotech for approximately $750 million cash, the companies said today—a deal that according to Danaher was prompted by its planned $21.4 billion acquisition of GE Life Sciences’ Biopharma business…”