This week’s headlines include: FDA authorizes Pfizer Covid-19 booster shots for children ages 5 to 11, As U.S. COVID-19 cases rise, so does demand for antivirals, US ‘vulnerable’ to COVID without new shots, FDA Launches Accelerated Rare Disease Cures Program, Kriya cashes in $270M series C to further finance all-in-one gene therapy biz, and With Promising Data, AVROBIO Plans Next Trial for Cystinosis Gene Therapy.

Upcoming Conferences:

World Biopharm Forum 2022 – University of Oxford, UK – June 22-24, 2022

World Biopharm Forum 2022 is preparing for their upcoming conference Value Through Intensified Process II to be held at Lady Margaret Hall, University of Oxford, UK on June 22nd – 24th, 2022.  It will provide introductions, reviews, and a few case studies of exciting advances in the materials, equipment, technology and processes supporting bioprocess intensification.
https://www.subramanian.org.uk/conferences/

Save the Date! 2022 Virtual 3D Cell Culture Summit on June 30, 2022

3D cell culture is exploding. To capture the energy and excitement of this moment in research, Corning is bringing together industry leaders and innovators for a global virtual 3D Cell Culture Summit to share ideas and information, and to discuss the future of 3D applications, including spheroid, organoid and tissue models. Join industry leaders and key influencers for this can’t miss life sciences event.

This is a free event hosted by Corning Life Sciences. To register, please visit: https://cvent.me/58Wa1L

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:

Increasing Single-Use Technology Operator Competency with New Training Methods

SUT training are cited as one of the top reasons for cGMP compliance inspection failures by drug manufacturers. Therefore, a concerted effort is needed in the biopharmaceutical industry to boost training competency across SUT operators. Recognizing the training gap, Pall Corporation and Lonza, embarked on a partnership to develop a standardized and comprehensive SUT training platform that combined the expertise of supplier and end-user. The program leverages a blend of digital media, virtual reality (VR) and in-person training tools to accommodate different learning styles. This variety of training tools helped to overcome the physical constraints of some types of single-use equipment to support the rapid and robust transfer of knowledge and skills required for consistent, strong performance…

Implementing Quality by Design for AAV Products

In this podcast, we talked with Parth Trivedi, Business Development Manager, Pall Corporation, about the importance of implementing a Quality by Design strategy for AAV product manufacturing and specific key steps for successful assessment…

Enhance Your Cell Culture Performance with Chemically Defined Peptides

Animal cell culture is a central process for successful bioproduction of therapeutic proteins, viral vectors (for vaccines and gene therapies) and therapeutic cells (for cell-based therapies), which help prevent, treat and cure human disease. Optimized cellular nutrition is the key to unlocking cost-effective, highly efficient bioprocesses. Amino acids are essential nutrients and critical ingredients in cell culture media required for in vitro cell survival and proliferation because of their role as building blocks for proteins. Standard practice in biopharma is to add free amino acids to media formulations based on the nutritional requirements of the cell type of interest. However, the stability and solubility of certain free amino acids have quickly become limiting factors to higher productivity requirements as part of industrialized biomanufacturing (i.e., fed-batch or perfusion culture). Optimal media composition with the best ingredients at the right concentration helps drive productivity gains, streamline workflows, and reduce operating costs…

Addressing the need for flexible large-scale virus production with an intensified, integrated platform

The biopharmaceutical industry has experienced unprecedented growth in recent years due to approvals for novel genomic medicines and increased need for agile, scalable vaccine production capacity to respond to emerging infectious diseases. This growth has placed tremendous pressure on virus manufacturers to increase and intensify virus production and provide industry stakeholders with superior solutions. Process intensification and integrated end-to-end continuous manufacturing are key to ensuring robust virus production with improved process economics…

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…

Increasing Liquid Chromatography Efficiency with Fully-controlled Binary Blending

In this podcast, we spoke with Cory Hinz, Engineering Manager at Asahi Kasei Bioprocess about the different methods that are available for liquid chromatography mobile phase solutions and the benefits of inline blending. Cory also describes how to implement binary blending feeding of a liquid chromatography process using inline blending…

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®…

Headlines:

“FDA authorizes Pfizer Covid-19 booster shots for children ages 5 to 11,” CNN