Firmenich | October 01, 2020
Firmenich, the world's largest privately-owned Perfume and Taste company, is proud to announce the opening of its new biotechnology and naturals pilot plant and laboratory in Geneva. Benefiting from the latest digital technology, the facility opens a new era for the development of ingredients and clean label solutions by providing faster speed-to-market and greater flexibility for customer collaboration. Integrated into the Group's flagship ingredients production site at La Plaine, Geneva, the facility operates to the highest safety and environmental standards, reducing waste and energy consumption. "With our new biotechnology pilot plant closely connected with the ingredients production site, Firmenich provides integrated biotech development all the way down to the finished product, without any gaps," said Genevieve Berger, Chief Research Officer, Firmenich. "Opening a new era in ingredients creation, our pilot plant and laboratory harnesses new technologies to improve clean label solutions, while the latest digital innovation maximizes efficiency." "Our new pilot plant provides greater flexibility to respond to customer needs in product development," said Sarah Reisinger, Senior Vice President Research Operations, Firmenich. "Capable of handling multiple projects simultaneously, it also enables small scale production of trial batches for formulation or testing and regulatory validation." Operational this month, the pilot plant at La Plaine is a cornerstone for new ingredients for both perfumery and flavors, enabling the development of the most efficient and high-quality production processes through biotechnology or natural extraction. Harnessing digital technology for increased automation, the pilot plant is able to move from single to continuous batch process, increasing efficiency, speed and reducing the use of raw materials.
Micreos | September 22, 2020
Dutch biotech company Micreos Human Health has enrolled the first patients in a Phase I/IIa, randomized, double-blind, placebo-controlled, parallel treated dose-ranging study to assess the safety and efficacy of XZ.700 in patients with mild to moderate atopic dermatitis. The study marks the world's first evaluation of a pharmaceutical endolysin for topical use in humans. Endolysins are highly specific enzymes that cut the bacterial cell wall, rapidly killing only the target bacteria, regardless of antibiotic resistance, while preserving the skin microbiome. XZ.700 specifically targets Staphylococcus aureus (S. aureus), a bacterium that is considered to be a causative and aggravating trigger for atopic dermatitis, and viewed as an independent cause of itch, irritation and infection. "The targeted removal of one particular bacterial species, S. aureus, from the skin microbiome, while preserving the beneficial ones is a fundamental new way to treat atopic dermatitis," says dermatologist Dr. Peter Lio, Scientific Advisor for Micreos and Scientific Advisory Board member for the National Eczema Association. XZ.700 is one of several endolysins Micreos has in its portfolio. A structurally similar endolysin, SA.100, is used in the company's over the counter (OTC) products for inflammatory skin disorders (e.g. acne and rosacea), found in the Gladskin range, which have been on the market since 2013. Data obtained in earlier Gladskin studies and feedback from doctors and thousands of customers support the pharmaceutical development program: "I am very encouraged by my experience with Gladskin and I am awaiting the findings with great anticipation." In this study, conducted in The Netherlands, XZ.700 will be tested for its safety as well as pharmacodynamics and efficacy in 48 patients with atopic dermatitis. They will be treated for 14 days with a cream containing XZ.700 at three different concentrations or placebo. Micreos expects to finish the study and report the results towards the end of 2021.
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).