Benchling | September 17, 2021
Benchling , innovator of the research and development (R&D) cloud for the biotechnology industry, today announced its entry into the early development market. The company brings new solutions to market that enable scientists for the first time to work seamlessly from research to development in a single system. By expanding the range of services, the Benchling R&D cloud is designed to offer both the flexibility and speed required for research efficiency as well as the control and conformity required for compliance with regulations.
The market and society are putting unprecedented pressure on R&D companies to develop new products and get them to market faster. Vaccines typically take years to develop. But in developing COVID-19 vaccines and therapies, researchers have been able to get them ready for clinical trials in a matter of months. Faster time to market for innovative biotech products can mean that patients can receive new treatments for life-changing diseases faster, such as the COVID-19 vaccines. It can also mean producing more food with less energy, enriching consumer lives with ethically sourced products, and making businesses more climate-friendly.
The development of such complex, important products requires modern technologies. Different individual solutions for electronic laboratory notebooks (ELN), laboratory information management systems (LIMS) and laboratory execution systems (LES) form silos that exacerbate the challenges of complex collaboration. They force scientists to spend time comparing data between different systems instead of gaining important insights that accelerate product development.
With more than 600 customers spanning a wide range of company sizes, industries and scientific use cases, Benchling relies on customer partnerships to expand its product range. Here are examples of benchling customers who have improved their development speed, scientific knowledge and collaboration within their R&D organizations:
Syngenta is one of the world's largest producers of novel seeds. Worldwide, 35 percent of food is rendered unusable by pests and diseases. New biological solutions and better built-in defense mechanisms not only protect against food waste, but also reduce the need for harmful chemicals that pollute the environment.
Syngenta's work relies on scaling, as our researchers: internally test hundreds of thousands of seeds in a variety of growing environments. When we discover viable varieties that meet the needs of farmers, we need to replenish our seed stocks quickly for testing in laboratories, greenhouses and field trials around the world,“Thanks to benchling, we said goodbye to paper. Our global seed R&D teams can efficiently work together on a single platform to standardize the development of seed varieties from the laboratory to the test field. This has enabled us to restructure much of our work and accelerate the time-to-market for new seed products.
- Charlie Baxter, Head of Traits, Regulatory and Product Safety at Syngenta.
New workflows: Benchling has expanded the workflows application to support collaboration between specialized R&D teams. Users can now coordinate tasks and processes across teams with full traceability, including methods, samples and inventory. Project managers gain insight into ongoing processes in order to reduce bottlenecks and increase productivity. Workflows help teams from research to development to work together more efficiently and to reach important milestones more quickly.
Structured Templates: With Benchling's new, more structured templates, product development teams can easily create common, standardized processes for repeatable experiments, analytical tests, QC protocols and more. These procedures can be regulated in a targeted manner in order to meet compliance requirements.
Validated cloud: At the beginning of 2021, Benchling switched to a validated cloud in order to be able to provide the platform for customers in a GxP environment.
Benchling is the pioneer for the R&D cloud, software that supports the biotechnology industry. Globally, more than 200,000 scientists in over 600 companies and 7,000 research institutions use Benchling's R&D cloud to make groundbreaking discoveries and bring the next generation of drugs, food and materials to market faster than ever before. The R&D cloud is helping these companies modernize their scientific processes and accelerate collaboration so they can transform the complexities of biology into world-changing results.
Xylyx Bio | September 30, 2020
Xylyx Bio, a leader in advanced disease models for drug discovery, today announced the launch of specialized contract R&D services that support improved assessment of antifibrotic drug candidate efficacy. Despite ongoing advances, the current drug discovery paradigm is highly inefficient. Approximately 40% of development costs are associated with preclinical studies, yet 80% of drug candidates fail before reaching Phase I trials, largely due to lack of translatability of efficacy data to humans. Commonly used assays have limited ability to predict how a drug candidate will act when introduced into patients, costing biopharma companies billions in the quest to determine which drugs will be most effective. To address this, Xylyx Bio now offers specialized contract R&D services based on its highly predictive IN MATRICO™ platform. Xylyx Bio's custom assays incorporate human disease-specific extracellular matrix (ECM) substrates combined with clinically relevant informatics to better represent human biology and reliably de-risk drug discovery through early efficacy signals that simultaneously reduce costs and development time.
Enteris BioPharma | May 04, 2021
Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies and a wholly-owned subsidiary of SWK Holdings Corporation, announced today the expansion of its Boonton, NJ manufacturing facility and the launch of its CDMO business segment, which provides custom solutions for the formulation, growth, and manufacturing of pharmaceuticals. Enteris also offers bench to market facilities, such as the development, manufacturing, monitoring, and release of Phase 1 to Phase 3 clinical trial supplies, as well as commercial products.
The 32,000-square-foot expanded facility includes 6,000 square feet of cleanroom space, with approximately 2,500 square feet devoted to the containment and processing of high potency API (HPAPI).
"This is a huge achievement for Enteris and will play an important role in our future growth plans," said Rajiv Khosla, Ph.D., Chief Executive Officer of Enteris. "Our purpose-built manufacturing facility will now manufacture CTM up to Phase 3, as well as product for commercial launch. These enhanced capabilities place Enteris to take advantage of a range of growth opportunities, and we plan to fully utilize this opportunity. Enteris will now seek deeper development and manufacturing collaborations with partners by offering custom solutions from bench to market."
The HPAPI containment area at the manufacturing plant is planned to safely accommodate highly potent APIs. Depending on the physical properties of the solid oral dosage unit, batch sizes can range from a few hundred to hundreds of thousands of dosage units. The facility also features 1,700 square feet of flexible suite space that can be customized to meet the development and manufacturing needs of a partner.
"Delivering on a construction timetable during the COVD-19 pandemic was no easy task, and the Enteris team is to be applauded for fulfilling the challenge," said Paul Shields, Ph.D., Enteris' Chief Operating Officer. "We look forward to using the enhanced manufacturing capabilities to deepen existing manufacturing relationships and strengthen our ability to secure new high-value relationships with companies seeking CDMO capabilities in the United States, regardless of whether the product is a solid oral formulation using our proprietary oral formulation technologies, Peptelligence® or ProPermaTM, or other tablet technology."
About Enteris BioPharma
Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation that provides complete integrated contract development and manufacturing (CDMO) services, including creative formulation methods that use its patented drug delivery technologies, Peptelligence® and ProPermaTM. Numerous feasibility trials and successful research projects have been conducted on the technologies, with many of them now in late-stage clinical development. Furthermore, Enteris BioPharma is developing an internal product pipeline of oral tablet reformulations of drug products that target significant treatment opportunities that do not have an oral delivery option.Ovarest® (oral leuprolide tablet), Enteris BioPharma's most advanced internal product candidate, is an oral peptide being developed for the treatment of endocrine disorders. Enteris BioPharma is also developing TobrateTM (oral tobramycin tablet) for the treatment of uncomplicated urinary tract infection (uUTI).