This week’s headlines include: Pfizer-Valneva’s Lyme disease vaccine performs even better in children, Quarter of US COVID-19 deaths could have been prevented by vaccination: analysis, Editas, VBL and Pharming Score Regulatory Wins On Development Journey, FDA finalizes guidance for drugs and biologics containing nanomaterials, U.S. FDA approves Gilead’s COVID-19 drug for young children, Fauci says vaccine approval for those under 5 likely not until June, and Biden admin to promote availability of COVID antiviral pill.

Podcasts:

Check out our podcast channel. We have over 50 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:

The cQrex^® GQ effect: Boosting viral vector yield and quality in HEK-based AAV-production

Adeno-associated virus (AAV) vectors are a platform technology for gene therapies. Prominent examples authorized for marketing in Europe and the U.S. include Luxturna^® and Zolgensma^® which are based on AAV2 and AAV9 respectively. For AAV alone, over 260 clinical trials are ongoing. As biopharmaceutical development progresses from clinical to commercial phases, there is an increasing need to improve the productivity of viral vector production processes…

Visualize Upstream and Downstream Process Intensification Strategies with New Process Intensifier App

Process intensification is an integral part of process design in biomanufacturing . This heightened awareness is due to the increased diversity and complexity of biomolecules and growing pressure to increase the productivity, flexibility and throughput of bioprocessing workflows while simultaneously reducing the cost of goods (COGS) and facility footprints. Process intensification as a holistic approach strives to achieve sustainable, highly productive, and cost-efficient processes by incorporating both upstream and downstream changes…

Understanding FBS Alternatives – Frequently Asked Questions

The ability to culture mammalian cells in vitro has been a vital scientific tool for decades and is used for a range of life sciences applications, from fundamental research to translational medicine. Fetal bovine serum (FBS) is the most widely used cell culture media supplement and has been an effective, broad-spectrum additive to support the growth of a range of cell types since the 1950s. FBS is a complex mixture of components, such as serum albumin, hormones, vitamins, trace elements, growth factors and other undefined constituents that support cell attachment, proliferation, and maintenance for many different cell types. FBS can also protect cells from large pH shifts by increasing the buffering capacity of the media and mitigates the physical cellular damage from shear forces during culture agitation…

Sophisticated multi-omics and bioinformatics-based CHO medium and feed enable a streamlined, highly productive mAb workflow

Chinese hamster ovary (CHO) cells are one of the preferred expression systems used by manufacturers to produce recombinant therapeutic proteins and monoclonal antibodies (mAbs). CHO cells have several advantages over other expression systems for biopharmaceutical manufacturing, including their favorable safety profiles, similarities in post-translational modifications to human cells (i.e., glycosylation), and their ability to grow in suspension cultures at high density. Three widely used CHO cell lines for bioproduction include CHO-K1, CHOS, and CHO-DG44…

Accelerating the Development and Manufacture of Therapeutics

The discovery, development, and commercial manufacturing of viral vectors, vaccines and other biotherapeutics can be a costly and lengthy endeavor. To shorten development timelines and bring novel therapies to market faster, rapid analytical tools are needed to support characterization, testing, and optimization activities necessary to achieve robust and cost-effective manufacturing. Sartorius offers the Octet® BLI platform based on biolayer interferometry (BLI) technology providing an alternative to conventional analytical techniques to support a wide range of bioprocessing-based applications. BLI technology can overcome the limitations in throughput, performance, and cost associated with traditional analytical platforms like UV spectroscopy, enzyme-linked immunosorbent assays (ELISAs), and high-performance liquid chromatography (HPLC)…

Agilitech Single-Use Tangential Flow Filtration (TFF) System for Biologics Manufacturing – A Case Study

Manufacturers in the biopharmaceutical industry are facing ever-expanding pipelines and the pressures to increase productivity and long-term sustainability while also rising to meet the challenges of new products with specialized processing requirements. This has led to increasing adoption of single use equipment into manufacturing workflows over traditional stainless-steel systems. While single use technology (SUT) designs have advanced for processes in both upstream and downstream unit operations, there are limitations to how tailored these units can be to fit the needs of a specific production process. Manufacturers are often required to adapt their process to what is commercially available resulting in technology solutions that may be suboptimal or unsustainable to meet future product demand. Those seeking more customization to a find ‘better fit’ are faced with piecemealing different components from different vendors into a contiguous system to achieve their production goals. Better engineering solutions are needed to create fit-for-purpose systems from the beginning that are cost-effective and scalable rather than the industry practice of reconfiguring standard systems. Addressing these gaps in process design requires thorough understanding of bioprocess requirements and equipment capabilities to build efficient processes to meet current production needs and ensure readiness to support future product growth…

Achieving Peak Flexibility – A single-use filtration skid with multiple application capability

Current expectations for biomanufacturing require downstream systems be responsive and flexible to meet ever changing demands and requirements. A common goal is to create processes that can adapt and evolve over time to meet new needs. To address this need, Agilitech has created a multipurpose filtration system that enables a new level of flexibility. Their compact, single-use multipurpose filtration can be adapted to virtually any commercially available external filtration system and the skid design allows customers to use one skid for multiple applications – sterile filtration, depth filtration, and virus filtration. To provide for future-proof systems, Agilitech encourages customers to partner and co-design solutions that are truly fit for purpose with designs that adapt to evolving needs…

Rapid Qualification Strategy of a Real-Time PCR Mycoplasma Detection Kit for an MSC-based Cell Therapy

Advanced therapies encompass a diversity of cell- and gene-based therapeutic platforms that are intended for human use. The exceptional promise of many cell and gene therapies to change the standard of patient care across a variety of disease indications has driven significant financial investment in the field and many products are now progressing through the clinical pipeline towards market approval. While approved products have already had a profound impact on patients, new scientific progress, clinical advances targeting large indications, and an evolving and supportive regulatory environment provide greater opportunity for these therapies in the future. Despite the forward progress, a stumbling point for cell and gene therapies has been that the condensed clinical development timelines, complex manufacturing processes, short shelf-life of the products, and supply chain challenges make it difficult for developers to ensure timely testing of quality and safety attributes…

Recombinant Human Serum Albumin Excipient – Regulatory Filing and Approval for Use in Vaccine Manufacturing

During the Excipient World Conference & Expo, supported by IPEC-Americas, Kara Quinn, the Associate Director of Engineering for Merck & Co, presented a webinar detailing the first-hand account of the complex process of regulatory agency filing that led to the regulatory approval, by both the FDA and EMA, for the use of a novel excipient, Exbumin™, in the manufacture of their first-in-class Ebola vaccine ERVEBO®…

DAC ERGO takes column changeover from unwieldy to manageable

Chromatography columns are an integral part of many biologic purification processes. As such there has been an increase in the use of large-scale columns, including popular stainless-steel Dynamic Axial Compression (DAC) columns. These columns are flexible as they allow packing of any required bed height to enable a variety of different media types and sizes. In addition, their design allows for a quick, easy and homogenous packed bed as well as an even distribution for plug flow of liquid to achieve better peak resolution…

Headlines:

“Pfizer-Valneva’s Lyme disease vaccine performs even better in children,” Fierce Biotech

Pfizer and Valneva’s Lyme disease vaccine worked even better in children than adults, leading the partners to add this population to a late-stage test slated to begin in the third quarter.In February, Pfizer and Valneva reported that VLA15 was immunogenic in adults after a three-dose series in the phase 2 study called VLA15-221, which built on evidence from earlier studies. The third dose helped add on another layer of protection by increasing the level of antibodies against an outer surface protein…

“Quarter of US COVID-19 deaths could have been prevented by vaccination: analysis,” The Hill

A new analysis finds that approximately 234,000 U.S. deaths from COVID-19 since June 2021 could have been prevented if people had been vaccinated. The analysis from the Peterson Center on Healthcare and the Kaiser Family Foundation underscores the importance of vaccination, and indicates a significant portion of the heavy toll from the virus could have been prevented…

“Editas, VBL and Pharming Score Regulatory Wins On Development Journey,” BioSpace

Editas Medicine snagged Rare Pediatric Disease designation for its experimental beta thalassemia gene therapy EDIT-301. The designation, awarded by the U.S.Food and Drug Administration, comes ahead of the initiation of a Phase I/II study later this year. The designation for beta thalassemia follows a previous Rare Pediatric Disease designation for EDIT-301 for the treatment of sickle cell disease. EDIT-301 is designed to edit the HBG1/2 promoter to disrupt the binding site of BCL11a and ameliorate disease symptoms…

“FDA finalizes guidance for drugs and biologics containing nanomaterials,” Regulatory Focus

The US Food and Drug Administration (FDA) has released its final guidance for industry on human drug and biological products that contain nanomaterials. Initial draft guidance for industry, released in December 2017, noted that FDA doesn’t distinguish between whether a drug or biologic with nanomaterials are benign or harmful, but products containing nanomaterials “may merit particular examination” regarding intrinsic and extrinsic factors to assess risks and benefits…

“U.S. FDA approves Gilead’s COVID-19 drug for young children,” Reuters

The U.S. drug regulator on Monday granted the first full approval for treating COVID-19 in children aged 28 days and older to Gilead Sciences Inc’s (GILD.O) drug remdesivir. The move comes months after the agency expanded the drug’s emergency use authorization to also include children below 12 years of age weighing at least 3.5 kilograms…

“Fauci says vaccine approval for those under 5 likely not until June,” The Hill

A COVID-19 vaccine for children under five might not be approved for emergency use until June, Anthony Fauci said on Thursday. Fauci, the chief medical adviser for President Biden, told CNN’s Kasie Hunt that health regulators were concerned because vaccine makers Moderna and Pfizer were creating slightly different products, which required additional scrutiny…