The Dish’s Weekly Biotechnology News Wrap Up – June 14, 2019
This week’s headlines include: Drugmakers Urge Changes to FDA Draft Guidance on Continuous Manufacturing, Measles Outbreak: N.Y. Eliminates Religious Exemptions for Vaccinations, Alzheimer’s Researchers Uncover Potential New Therapeutic Target, Saga Diagnostics raises $4.1M for its ultrasensitive cancer blood tests, and AstraZeneca’s blood cancer drug meets main goal in late-stage trial.
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In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:
Novel Acoustic Platform Provides Gentler, More Efficient Solution for Cell Processing
Cell and gene therapies are in need of evolving manufacturing technologies to move products from research, through development and into, commercial manufacturing. As more cell and gene therapy products achieve clinical success, more investments are being made in creating manufacturing technologies to support the industry. There are several advancements in this area including the closing and automating of many manufacturing processes and increasing efficiencies with the creation of fit for purpose equipment and consumables. There are still, however, many needed improvements to further increase productivity and reduce cost…
Rapid Mycoplasma Testing for Biomanufacturing Applications
Increasingly the quality of raw materials used in cell culture media and supplements is being closely examined for any potential negative impact on cell culture or the final product quality. One area of concern is biomanufacturing contamination. While there are certainly many possible entry points for cell culture contamination, contaminated raw materials is high on the list. Of the possible contaminants, mycoplasma is often a big concern because it is fairly resilient in laboratory environments, resistant to most, if not all antibiotics, and also contamination in culture is not always obvious. Yet, mycoplasma contamination can have a devastating impact on biopharmaceutical development and production. As a result, having adequate mycoplasma monitoring in place is critical for minimizing the risk and ultimately impact of contamination…
Optimizing Fed Batch Culture – Developing New Tools and Methods to Improve Production
The past decade has seen a surge in the development of gene therapies. Currently there are over 1,000 cell and gene therapy clinical trials underway worldwide.1 While the majority of current trials are still in Phase I or Phase II, there are more than 90 trials in Phase III. In fact, at last year’s BIO International Convention, Scott Gottlieb, Commissioner of the US Food and Drug Administration (FDA) stated that he expects the FDA to approve 40 gene therapies by 2022.2…
Transfection Reagent Portfolio Enables Seamless Scalability from R&D to Commercial Therapeutic Viral Vector Manufacturing
One common challenge in viral vector production is transitioning from research-based production to more rigorous quality and safety profiles for clinical and commercial manufacture. In fact, raw materials used in production at research scale are often not cGMP-compliant and therefore fit for clinical or commercial manufacturing. This means that critical raw materials frequently need to be replaced with cGMP grade material sourced from approved suppliers during process scale up. cGMP grade materials are manufactured under strict conditions and must pass rigorous testing. This higher manufacturing standard reduces the risk of introducing adventitious agents into clinical and commercial viral vector manufacturing…
Spheroid Cell Culture – Practical solutions for frequently asked questions
The past decade has seen an increase in publications recognizing the value of culturing cells in three dimensions (3D) and the use of these 3D cell culture models has shown utility in many areas of research from cancer biology to regenerative medicine. One of the most common 3D cell culture types is spheroids. Spheroids more accurately recapitulate the native in vivo microenvironment with respect to cellular function and response to drugs than more traditional two-dimensional (2D) models. That said, working with spheroids is not without its challenges. Many labs working with spheroids have run into technical hurdles incorporating them into existing cell culture workflows. Whether it is issues with handling or optimizing protocols to assaying cells in 3D, these obstacles can be overcome…
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…
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…
Conferences:
June 18-20, 2019
Park Central Hotel,
San Francisco, CA
Driving Value Through Intensified Bioprocessing
Attendees will benefit from learning about the current state-of-the-art advancements in continuous manufacturing and also learn about the successful organizations that are developing these methods in-house through the industrial case studies and workshops. Together we will drive change, innovate growth and pioneer smarter technologies to ensure they reach their full potential.
Headlines:
“Drugmakers Urge Changes to FDA Draft Guidance on Continuous Manufacturing,” FDA News
“Drug manufacturers and trade groups are calling for modifications to the FDA’s draft guidance on continuous manufacturing quality considerations. In comments posted to the docket, some drugmakers and drug associations urged the FDA to think carefully about the draft guidance. GlaxoSmithKline, Europe’s Active Pharmaceutical Ingredients Committee (APIC), and the International Pharmaceutical Excipients Council of the Americans all pointed out, for instance, that the International Council for Harmonization guideline on the same topic—ICH Q13—is pending…”
“Measles Outbreak: N.Y. Eliminates Religious Exemptions for Vaccinations,” The New York Times
“Lawmakers in New York, the epicenter of the nation’s measles outbreak, voted on Thursday to end religious exemptions for immunizations, overcoming opposition by vaccine skeptics and others who said the measure infringed on religious and constitutional rights…”
“Alzheimer’s Researchers Uncover Potential New Therapeutic Target,” Genetic Engineering News
“From a drug perspective, it would not be an exaggeration to say that therapies developed to treat Alzheimer’s disease (AD) have fallen short. Yet thankfully, due to the perseverance of neuroscience researchers, there is no shortage of potential drug targets aimed at slowing the progression or even preventing AD. For instance, apolipoprotein E (apoeE) is a major genetic risk factor for the development of Alzheimer’s disease. However, this protein tends to be understudied as a potential druggable target for the mind-robbing neurodegenerative disease…”
“Saga Diagnostics raises $4.1M for its ultrasensitive cancer blood tests,” Fierce Biotech
“Saga Diagnostics has raised 40 million Swedish kronor, or about $4.1 million, to help develop its ultrasensitive liquid biopsy tests for the monitoring of cancer treatments. A spinout from Lund University in Sweden, Saga aims to quantify aberrations in DNA, RNA and strands of circulating tumor DNA in the bloodstream using massive parallel sequencing and digital PCR…”
“AstraZeneca’s blood cancer drug meets main goal in late-stage trial,” Reuters
“AstraZeneca Plc said on Thursday its blood cancer drug met the main goal of a final stage trial, taking the treatment one step closer to a marketing approval as the drugmaker seeks to bolster its oncology portfolio. In its second late-stage trial success in a month, the drug showed meaningful improvement in patients with chronic lymphocytic leukemia when compared with a chemotherapy-based treatment, the company said…”