BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | April 06, 2023
Societal CDMO, Inc. a contract development and manufacturing organization announced that it has been selected by Longboard Pharmaceuticals, Inc. to provide CDMO services. The agreement spans a range of Societal CDMO’s offerings including technology transfer and analytical method validation activities to support Longboard’s lead asset, LP352, a 5-HT2C receptor superagonist. LP352 is currently being evaluated in the PACIFIC Study, a Phase 1b/2a basket trial, in participants with developmental and epileptic encephalopathies or DEEs, such as Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex, CDKL5 deficiency disorder, SCN2A-related disorders, among others.
“This agreement with Longboard offers an excellent illustration of the strides that Societal CDMO continues to make in establishing itself as a preferred CDMO partner for biopharmaceutical companies developing innovative therapeutic candidates. The scope of work for this project highlights the broad range of services we offer to support drug developers as they advance their innovative candidates through clinical development, spanning tech transfer through to cGMP manufacturing,” said David Enloe, chief executive officer of Societal CDMO. “We are grateful for the trust that Longboard has placed in our team to make a contribution to the development of an important therapeutic that has the potential to meaningfully impact the lives of patients in need. At the end of the day, that is the mission that drives all members of the Societal CDMO team.”
About Societal CDMO
Societal CDMO is a bi-coastal contract development and manufacturing organization with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.
RESEARCH, PHARMA TECH
Biocytogen | March 09, 2023
On March 8, 2023, Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen) announced a non-exclusive license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The deal was facilitated by Johnson & Johnson Innovation LLC.
Under the agreement, Janssen and its affiliates have been granted a global, non-exclusive license to utilize Biocytogen's RenLite® platform and its underlying intellectual property to research, discover, develop, manufacture and commercialize fully human antibody therapeutics, as well as other biological therapeutics, for unlimited drug targets and indications.
RenLite® is a part of Biocytogen's RenMiceTM family of completely human antibodies. RenLite® mice can produce fully human antibody candidates with high affinity, specificity, variety, and druggability, as well as a common light chain for further assembly of multispecific and bispecific antibodies with minimal mismatch and high success rate. In addition, the multispecific and bispecific antibodies assembled following the discovery of RenLite® feature a conventional antibody structure and good physiochemical characteristics that are beneficial for downstream CMC development.
Biocytogen is a leading biotech company that offers comprehensive solutions to the global biomedical community for developing next-generation antibody drugs. It has created a streamlined platform for efficient antibody drug discovery and validation using advanced gene editing technology and modern animal facilities. This includes animal model creation, therapeutic antibody discovery through their RenMab™ mice, and preclinical validation studies in vivo and in vitro. Biocytogen partners with over 70% of the leading biotech and pharmaceutical companies worldwide to develop innovative medicines for a healthier world. The company is a leading figure in the field of biomedical research, pushing the boundaries of what is possible in this critical area of study.
Businesswire | June 02, 2023
REALM IDx announced the launch of REALM Pharma Services, an end-to-end discovery, translational research, and clinical trial service for biotechnology and pharmaceutical partners. Through a strategic integration, REALM Pharma Services brings together the research arms of subsidiaries, Ambry Genetics and Invicro, to offer cutting-edge genomics, traditional and molecular pathology, and advanced imaging and spatial biology. Combined with machine learning and artificial intelligence (AI) from REALM’s informatics organization, the company believes this end-to-end service can help reveal new insights and develop multi-dimensional models for drug discovery and validation.
“We are excited to offer a comprehensive multiomic and multimodal program that has been tailored to support the needs of our biopharma partners,” said Aaron Elliott, PhD, CEO of REALM IDx. “We believe the integrated approach offered through REALM Pharma Services is a transformative shift in research and will bring new, data-driven insights to precision medicine.”
Use of advanced omics, including single-cell omics, is increasingly being incorporated by biopharma into discovery and research efforts, particularly in the field of cancer. This approach can support improved understanding of biological complexity in immuno-oncology and a system-wide path to drug efficacy. However, a significant challenge has been the lack of a consolidated infrastructure to not only support analytical testing and data collection, but also computational analysis of unique data sets to find novel associations for translational insights.
“In supporting our biopharma partners, we see ourselves as a powerful connecting force,” said Jonathan Usuaka, PhD, Chief Strategy and Informatics Officer for REALM IDx. “Along with world-class genomics, pathology, spatial imaging and analysis services, we support real-world data and advanced analytics to inform drug development at every stage.”
The company will introduce REALM Pharma Services while exhibiting at the upcoming American Society of Clinical Oncology annual conference in Chicago, June 3 – 5. While at the conference, the company will also share details of a new comprehensive genomic profiling test (CGP) for cancer developed in collaboration with its partners in Japan and set to launch this summer. Additional information about REALM Pharma Services may be found on REALM’s website.
About REALM IDx
REALM IDx, Inc. is a health care company pioneering in the field of Integrated Diagnostics (IDx), an advanced field of clinical science that brings together laboratory medicine, radiology, pathology and sophisticated artificial intelligence to derive actionable insights to predict, diagnose and treat disease. Powered by proprietary software platforms, industry-leading genomics technology from Ambry Genetics Corporation and radiology and pathology services from Invicro, LLC, the company is equipped to collect, analyze and report on multi-modal precision diagnostic data sets.