INDUSTRIAL IMPACT, DIAGNOSTICS
Globenewswire | April 10, 2023
Avid Bioservices, Inc. a dedicated biologics contract development and manufacturing organization working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, announced the completion of two expansions within the company’s mammalian cell facilities. The company expects that the first customer for the newly expanded CGMP mammalian cell suites will begin manufacture this month. To celebrate the launch of the newly expanded facilities, Avid is hosting an open house and tour for existing and prospective clients.
“We are proud to unveil our completed expansions and excited to kick off the first customer project within our latest, state-of-the-art mammalian cell manufacturing suites. These build-outs involved great complexity and required exemplary efforts from our entire team. I would like to acknowledge the tremendous work from everyone who played a role in completing these significant projects on schedule,” said Nick Green, president and chief executive officer of Avid Bioservices. “This launch could not be timed any better based on the significant demand we continue to see for our mammalian cell services, highlighted by significant new business wins and the largest backlog in the history of the company.”
The newly expanded manufacturing capacity includes both upstream and downstream CGMP manufacturing suites and serves as complement to Avid’s existing Myford facility, providing increased capacity to address the needs of both existing and future mammalian cell business customers. The addition of the capacity provided by the new manufacturing suites within the Myford facility has the potential to generate approximately an additional $100 million in annual revenue.
In addition to the launch of the newly expanded Myford facility, Avid also announced the completion of its mammalian cell process development expansion, which has doubled the company’s total process development capacity. Now operational, these new capabilities have the potential to support up to an additional $25 million in annual process development revenue.
With the completion of these mammalian cell capacity expansion projects, Avid’s sole ongoing expansion effort involves the build-out of its new cell and gene therapy facility which will support early-stage development through commercial manufacturing. The company has already launched analytical and process development capabilities at this viral vector facility and remains on track to launch the CGMP manufacturing suites by the end of the third quarter of calendar 2023.
Upon completion of the CGT Facility, we estimate that our combined facilities will have the potential to bring our total revenue generating capacity to up to approximately $400 million annually.
About Avid Bioservices, Inc.
Avid Bioservices an S&P SmallCap 600 company, is a dedicated contract development and manufacturing organization focused on development and CGMP manufacturing of biologics. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 30 years of experience producing monoclonal antibodies and recombinant proteins, Avid's services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs the company provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization. The scope of our services ranges from standalone process development projects to full development and manufacturing programs through commercialization.
PRNewswire | June 06, 2023
PhenomeX Inc. the functional cell biology company, announced the launch of the Beacon Quest™ optofluidic system, with Opto® T Cell Profiling workflows for immunotherapy translational research and a platform price under $1 million USD, less than half of the higher-throughput Beacon system, enabling broader accessibility to the cutting-edge technology critical for next-generation precision medicine.
The Opto T Cell Profiling workflows have enabled scientists to comprehensively profile single T cells to correlate polyfunctionality with cytotoxicity and recover those same cells for downstream analysis such as transcriptome and genome sequencing, revealing functional connections of phenotype with molecular mechanism. This depth of understanding of biology and response to therapeutics is not available on any other platform. Combined with the value-matched Beacon Quest system, more academic, non-profit, and government customers can now access the power of optofluidic and NanoPen® chamber technology and propriety single T Cell Profiling applications along with the optimum level of features to meet their research and budgetary needs.
"At PhenomeX, we are excited to launch the Beacon Quest, as it supports our objective of offering scientists and researchers globally the ability to affordably access the main applications of the Beacon system, including antibody discovery, cell line development and single-cell functional multiomic T-cell profiling," said Siddhartha Kadia, Ph.D., chief executive officer of PhenomeX. "We look forward to partnering with and providing significant value in the academic research segments, particularly in immuno-oncology translational cancer centers and innovative cell and gene therapy development centers."
Beacon Quest for T Cell Profiling Workflow Features
Opto T Cell Profiling workflows on the Beacon Quest system enable multi-functional characterization of single T cells, including for development of efficacious immunotherapies and cell-based cancer therapeutics, that are ideally suited for academic, non-profit, and government customers.
The Beacon Quest system enables a variety of assays to profile single T cells including detection of cytokine secretion, cytotoxicity, cell surface markers, transcriptome profiling and TCRSeq, with the potential to study growth characteristics and cell motility. The resulting analysis is used to identify cells with phenotypes of interest and guide recovery of the same cells for downstream assays, enabling researchers to gain a deeper understanding of the underlying biology by
Investigating molecular mechanisms associated with polyfunctional T cells;
Identifying desirable phenomes by correlating polyfunctionality with cytotoxicity; and
Linking desirable phenotypes to T cell receptor sequences of the same cells.
In addition to supporting the Opto T Cell Profiling workflows, Beacon Quest will enable customers to access the Opto B Discovery workflows and Opto Cell Line Development workflows. To further increase customer accessibility and affordability, PhenomeX will also offer reduced priced OptoSelect® chips (OptoSelect® Research chips) for Beacon Quest, helping academic customers accelerate the pace of scientific discovery for clinical research use applications.
About PhenomeX Inc.
PhenomeX is empowering scientists to leverage the full potential of each cell and drive the next era of functional cell biology that will advance human health. We enable scientists to reveal the most complete insights on cell function and obtain a full view of the behavior of each cell. Our unique suite of proven high-throughput tools and services offer unparalleled resolution and speed, accelerating the insights that are key to advancing discoveries that can profoundly improve the prevention and treatment of disease. Our award-winning platforms are used by researchers across the globe, including those at the top 15 global pharmaceutical companies and approximately 85% of leading U.S. comprehensive cancer centers.
CELL AND GENE THERAPY, INDUSTRY OUTLOOK
Globenewswire | May 10, 2023
Adaptive Biotechnologies Corporation a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to detect and treat disease, announced that the U.S. Food and Drug Administration has accepted an investigational new drug (IND) application submitted by its collaborator, Genentech, a member of the Roche Group, for a T-cell receptor (TCR) based T-Cell Therapy. This is the first TCR-based therapeutic product candidate to advance into clinical development based on Adaptive’s collaboration with Genentech in oncology.
“This IND acceptance reaffirms the value of our immune medicine platform and Adaptive’s ability to identify and characterize clinical grade, therapeutic T-cell receptors, which is the cornerstone of our drug discovery capabilities,” said Chad Robins, chief executive officer and co-founder, Adaptive Biotechnologies. “We look forward to supporting Genentech’s world-class team of scientists and drug developers to advance this potentially life-saving therapy into the clinic for patients with solid tumors.”
Under the terms of Adaptive and Genentech’s collaboration agreement, Genentech has responsibility for clinical, regulatory and commercialization efforts for any T-Cell Therapy product candidate. Adaptive reiterates its full year revenue guidance in the range of $205 to $215 million.
About Adaptive Biotechnologies
Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.