This week’s headlines include: Trump signs executive order to improve flu vaccines, FDA Compiles List of NDAs Transitioning to BLAs Next March, Nucleus Biologics launches Concierge™ Media Manufacturing Services, bringing transparency to cell culture media, JSR, PeptiDream Partner on Development Program for Affinity Chromatography, and FDA approves Bavarian Nordic’s monkeypox vaccine.

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:

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…

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…

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…

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.

La Jolla, CA – Wednesday, October 16, 2019 – Click here for information on the La Jolla workshop

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

Conferences:

World ADC San Diego

October 8 – October 11

Grand Hyatt San Diego, 1 Market Place
San Diego,CA92101United States+ Google Map

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…

Find out more »

Headlines:

“Trump signs executive order to improve flu vaccines,” CIDRAP

“President Donald Trump yesterday issued an executive order directing the US Department of Health and Human Services (HHS) to overhaul seasonal flu vaccine production and urge more Americans to be vaccinated. The executive order, titled “Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health,” promotes new vaccine manufacturing technologies to support more robust vaccines and advances the development of vaccines that provide longer lasting coverage against a broad range of flu viruses…”

“FDA Compiles List of NDAs Transitioning to BLAs Next March,” Regulatory Focus

“The US Food and Drug Administration (FDA) on Tuesday released a preliminary list of the new drug applications (NDAs) that will be converted to biologics license applications (BLAs) on 23 March 2020. The shift is caused by the Biologics Price Competition and Innovation Act of 2009, which clarified the statutory authority under which certain protein products will be regulated by amending the definition of a “biological product” to include a “protein (except any chemically synthesized polypeptide).”

“Nucleus Biologics launches Concierge™ Media Manufacturing Services, bringing transparency to cell culture media,” PR Newswire

“Nucleus Biologics, a leader in precision cell culture, has announced the broader launch of Concierge™ Media Manufacturing Services. This offering fits Nucleus Biologics’ mission “to speed the time from discovery to cure” by offering customization and optimization of cell culture media while providing transparency with the list of components in each media formulation. Nucleus Biologics believes that the historical model for delivering cell culture media to scientists is broken. The industry norm of marketing proprietary, sole source cell culture media formulations and other raw materials are hindering cell therapy research and the scaled commercialization environment. According to David Sheehan, Founder, President and CEO of Nucleus Biologics, “How can a researcher improve a cell therapy when half the ecosystem is unknown? We operate in accordance with, what we call, the Scientist Bill of Rights on Media. Scientists should: know what is in your media, be able to customize it, and have a second source.  This service addresses those needs while providing cost effective, cGMP media.”

“JSR, PeptiDream Partner on Development Program for Affinity Chromatography,” BioPharm International

“JSR, a technology-focused materials supplier in Tokyo, Japan, announced that its JSR Life Sciences division is beginning a joint development program with PeptiDream, a Tokyo-based biopharmaceutical company, to identify peptides applicable to the affinity chromatography process used in the purification of biopharmaceuticals…”

“FDA approves Bavarian Nordic’s monkeypox vaccine,” Reuters

“The U.S. Food and Administration on Tuesday approved Danish drugmaker Bavarian Nordic’s Jynneos, making it the first approved vaccine for preventing monkeypox disease. Monkeypox is a rare viral infection that does not spread easily from person to person. Infections have until recently been limited to central and western regions of Africa, but cases have been reported in Britain last year and in Singapore earlier this year…”