Home > News > featured news > Curia Collaborates with Corning to Advance Biopharmaceutical Continuous-Flow Development and Manufacturing Programs

BUSINESS INSIGHTS, PHARMACY MARKET

Curia Collaborates with Corning to Advance Biopharmaceutical Continuous-Flow Development and Manufacturing Programs

Globenewswire | March 24, 2023 | Read time : 02:00 min

Curia Collaborates with Corning

Curia, a leading contract research, development and manufacturing organization, today announced a collaboration with Corning Incorporated to expand and accelerate continuous-flow development and manufacturing programs for the chemical and biopharmaceutical industries globally. The collaboration with Corning’s Advanced-Flow™ Reactor (AFR) team includes the first installation of Corning’s G1 production system, designed for the continuous industrial production of active pharmaceutical ingredients (API).

Continuous flow chemistry is critical for the development and manufacture of pharmaceutical intermediates and APIs, and provides advantages compared with traditional batch processing. It is an inherently safer technology that delivers faster and more robust material production with a higher selectivity of desired products.

“Innovation in drug development and production calls for safety at high speed,” said Christopher Conway, president, Research & Development, Curia. “The implementation of Corning’s G1 Production Reactor at our Albany facility expands our capability to provide scalable solutions that address complex development and manufacturing requirements facing the pharmaceutical industry. Using advanced technology and standardized workflows, Curia offers continuous flow chemistry from targeted development to commercial scale globally.”

The G1 production reactor includes an updated set of dosing lines and controls that enable continuous operations and compliance to cGMP standards.

“Collaborating with an innovation-focused company like Curia will help drive advancements in the chemical-processing industry,” said Alessandra Vizza, business director, Corning Advanced-Flow Reactors. “The implementation of Corning’s G1 production system can deliver a host of benefits. The system is an inherently safer technology that will help Curia reduce time to market with higher-quality chemical and API processing, increased efficiency of chemical and API synthesis, and lower production costs.”

“Additionally, the space-saving, energy-conserving, and waste-reducing benefits of Corning’s AFR Technology may help customers reduce the environmental impact of their manufacturing business – a key attribute as the field continues to gain momentum in the U.S. and around the world,” said Vizza.

Curia’s expertise and global network of facilities, combined with Corning’s continuous flow technology, can help drive business efficiencies and, ultimately, improve patients’ lives.

About Curia

Curia is a leading contract research, development, and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s nearly 4,000 employees at 29 locations across the U.S., Europe, and Asia help its customers advance from curiosity to cure.

Spotlight

ValGenesis e-Logbook

ValGenesis e-Logbook eliminates traditional, error-prone, paper-based logbooks for any GMP log type. Say goodbye to illegible handwritten entries, sticky notes, lost logbooks, and cleanroom contamination concerns. Welcome fully compliant, next-generation efficiency.

More featured news

Spotlight

ValGenesis e-Logbook

ValGenesis e-Logbook eliminates traditional, error-prone, paper-based logbooks for any GMP log type. Say goodbye to illegible handwritten entries, sticky notes, lost logbooks, and cleanroom contamination concerns. Welcome fully compliant, next-generation efficiency.

Related News

BUSINESS INSIGHTS

Eyenovia Announces FDA Approval of Mydcombi™, the First Ophthalmic Spray for Mydriasis, Which Also Leverages the Company’s Proprietary

Globenewswire | May 09, 2023

Eyenovia, Inc. an ophthalmic technology company developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, announced that the U.S. Food and Drug Administration (FDA) has approved Mydcombi 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia’s proprietary Optejet device to be approved by any regulatory authority. Mydcombi is designed to improve the efficiency of the estimated 106 million office-based comprehensive eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. The product is contraindicated and should not be used in patients with known hypersensitivity to any component of the formulation. “The approval of Mydcombi, our first FDA approved product, represents the culmination of years of tireless effort by the entire Eyenovia team, and I would like to express my sincere gratitude to the associates and technical experts who helped advance this important program through this transformational milestone,” stated Michael Rowe, chief executive officer of Eyenovia. “We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities on-line for 2024.” “Perhaps more importantly, FDA approval of Mydcombi provides critical validation of the Optejet as it is the first product approved using the Optejet platform, which is core not only to our internal development programs, including MicroLine for presbyopia, but our partnered programs as well. We see opportunities to unlock significant opportunities in the future treatment of other ophthalmic conditions including glaucoma and dry eye. I am confident in our ability to maintain our current momentum.” “I am proud of our team for this significant achievement – which represents many ‘firsts’ for eye care,” stated Dr. Sean Ianchulev, Founder and Chairman of Eyenovia’s Board of Directors. “The use of eye dropper bottles has presented challenges for dosing in ophthalmologic settings in millions of patients. We can do better now using sophisticated micro-array print delivery with physiologic dosing that is similar to the natural tear film volume.” Eyenovia management will provide additional updates on Mydcombi as well as its ongoing development programs and partnerships during its regularly scheduled first quarter 2023 update conference call and webcast on May 11th, 2023. About Eyenovia, Inc. Eyenovia, Inc. is a commercial stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the commercialization of Mydcombi for mydriasis, as well as the ongoing late-stage development of medications in the Optejet device for presbyopia and myopia progression.

Read More

BUSINESS INSIGHTS, PHARMA TECH

Hovione and Ripple Enter Strategic Partnership to Expand Epidel® Platform into Non-Ophthalmic Space

Hovione | March 21, 2023

Hovione, the specialist integrated CDMO, leader in spray drying and particle engineering, and Ripple Therapeutics, a leading ophthalmic sustained drug delivery company, have entered a strategic partnership to expand the use of Ripple's Epidel® platform beyond ophthalmic applications. The core feature of Ripple's Epidel® technology is the ability to deliver sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. This enables higher drug loading, smaller size implants, defined and predictable biocompatible degradation products with straightforward and scalable manufacturing processes. Surface erosion-based drug release provides a highly effective way to control dose and duration. By incorporating Ripple's Epidel® platform into its toolbox, Hovione can expand its portfolio of novel drug delivery solutions to the pharmaceutical industry. "The combination of technology synergy, innovative vision and cultural fit makes collaborating with Hovione an exciting next step in the advancement of the Epidel® platform beyond the ophthalmic field," stated Dr. Wendy Naimark, Ripple co-founder and Chief Technology Officer. "Hovione's expertise in controlled, sustained drug delivery, along with their experience in chemical synthesis and pharmaceutical manufacturing, makes for a great partnership." "We are thrilled to partner with Ripple, who developed a state-of-the-art platform for sustained release," says Dr. Jean-Luc Herbeaux, Hovione's CEO. " Our shared goal is to accelerate and broaden the access to this highly innovative and enabling technology for the benefit of our pharmaceutical customers and their patients worldwide." By extending the use of the Epidel® platform beyond ocular applications, this partnership will enable the development of a diverse range of new products with optimal sustained release profiles. About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione's culture is based on innovation, quality and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About Ripple Therapeutics Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple's Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. Ripple's novel therapeutics provide for better outcomes for patients, easier management of care for physicians and lower costs for payors. Ripple has a full product pipeline in development.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

Enanta Pharmaceuticals Receives FDA Fast Track Designation for EDP-323, its Oral, L-Protein Inhibitor in Development

Businesswire | April 10, 2023

Enanta Pharmaceuticals, Inc. a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDP-323, Enanta’s L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV). "Receiving Fast Track designation from the FDA underscores EDP-323’s potential as a once-daily, oral therapeutic for the treatment of this deadly virus and reflects the pressing need for a highly potent, direct antiviral to treat RSV, particularly for high-risk populations,” said Scott T. Rottinghaus, M.D., Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals. “Given that EDP-323 has shown sub-nanomolar potency against several RSV-A and RSV-B strains in vitro and is not expected to have cross-resistance to other classes of inhibitors, we believe it could be used as a monotherapy or in combination with other RSV mechanisms to potentially broaden the addressable RSV patient populations or the treatment window. We believe this designation will be a valuable component of our clinical and regulatory strategy as we progress EDP-323 in development.” The Fast Track program is designed to accelerate the development and review of products such as EDP-323, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation enables more frequent communication with the FDA and eligibility for FDA programs such as priority review and rolling review, if relevant criteria are met. EDP-323 is being evaluated in a Phase 1 double-blind, placebo-controlled study designed to assess its safety, tolerability, and pharmacokinetics (PK). Enanta plans to present new preclinical PK data at the European Congress of Clinical Microbiology and Infectious Diseases in April and expects to report topline data from the Phase 1 study this quarter. EDP-323 is supported by in vitro data demonstrating a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B, with consistent potency across a range of RSV clinical isolates in various cell types. In a mouse model of RSV infection, EDP-323 treatment was associated with dose-dependent decreases in viral load in the lung, reduced lung immunopathology and decreases in pro-inflammatory cytokines, including IFNγ, TNFα, and IL1β. Additionally, EDP-323 has favorable oral bioavailability with good plasma exposures across preclinical species and pharmacokinetic properties supporting once-daily, oral dosing in humans. These data indicate that EDP-323 is a potent inhibitor of RSV replication and has the potential to be a best-in-class, once daily, oral antiviral treatment for RSV. About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections. Enanta’s research and development programs include clinical candidates for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 and hepatitis B virus. Enanta is also conducting research on a single agent targeting both RSV and human metapneumovirus.

Read More

BUSINESS INSIGHTS

Eyenovia Announces FDA Approval of Mydcombi™, the First Ophthalmic Spray for Mydriasis, Which Also Leverages the Company’s Proprietary

Globenewswire | May 09, 2023

Eyenovia, Inc. an ophthalmic technology company developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, announced that the U.S. Food and Drug Administration (FDA) has approved Mydcombi 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia’s proprietary Optejet device to be approved by any regulatory authority. Mydcombi is designed to improve the efficiency of the estimated 106 million office-based comprehensive eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. The product is contraindicated and should not be used in patients with known hypersensitivity to any component of the formulation. “The approval of Mydcombi, our first FDA approved product, represents the culmination of years of tireless effort by the entire Eyenovia team, and I would like to express my sincere gratitude to the associates and technical experts who helped advance this important program through this transformational milestone,” stated Michael Rowe, chief executive officer of Eyenovia. “We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities on-line for 2024.” “Perhaps more importantly, FDA approval of Mydcombi provides critical validation of the Optejet as it is the first product approved using the Optejet platform, which is core not only to our internal development programs, including MicroLine for presbyopia, but our partnered programs as well. We see opportunities to unlock significant opportunities in the future treatment of other ophthalmic conditions including glaucoma and dry eye. I am confident in our ability to maintain our current momentum.” “I am proud of our team for this significant achievement – which represents many ‘firsts’ for eye care,” stated Dr. Sean Ianchulev, Founder and Chairman of Eyenovia’s Board of Directors. “The use of eye dropper bottles has presented challenges for dosing in ophthalmologic settings in millions of patients. We can do better now using sophisticated micro-array print delivery with physiologic dosing that is similar to the natural tear film volume.” Eyenovia management will provide additional updates on Mydcombi as well as its ongoing development programs and partnerships during its regularly scheduled first quarter 2023 update conference call and webcast on May 11th, 2023. About Eyenovia, Inc. Eyenovia, Inc. is a commercial stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the commercialization of Mydcombi for mydriasis, as well as the ongoing late-stage development of medications in the Optejet device for presbyopia and myopia progression.

Read More

BUSINESS INSIGHTS, PHARMA TECH

Hovione and Ripple Enter Strategic Partnership to Expand Epidel® Platform into Non-Ophthalmic Space

Hovione | March 21, 2023

Hovione, the specialist integrated CDMO, leader in spray drying and particle engineering, and Ripple Therapeutics, a leading ophthalmic sustained drug delivery company, have entered a strategic partnership to expand the use of Ripple's Epidel® platform beyond ophthalmic applications. The core feature of Ripple's Epidel® technology is the ability to deliver sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. This enables higher drug loading, smaller size implants, defined and predictable biocompatible degradation products with straightforward and scalable manufacturing processes. Surface erosion-based drug release provides a highly effective way to control dose and duration. By incorporating Ripple's Epidel® platform into its toolbox, Hovione can expand its portfolio of novel drug delivery solutions to the pharmaceutical industry. "The combination of technology synergy, innovative vision and cultural fit makes collaborating with Hovione an exciting next step in the advancement of the Epidel® platform beyond the ophthalmic field," stated Dr. Wendy Naimark, Ripple co-founder and Chief Technology Officer. "Hovione's expertise in controlled, sustained drug delivery, along with their experience in chemical synthesis and pharmaceutical manufacturing, makes for a great partnership." "We are thrilled to partner with Ripple, who developed a state-of-the-art platform for sustained release," says Dr. Jean-Luc Herbeaux, Hovione's CEO. " Our shared goal is to accelerate and broaden the access to this highly innovative and enabling technology for the benefit of our pharmaceutical customers and their patients worldwide." By extending the use of the Epidel® platform beyond ocular applications, this partnership will enable the development of a diverse range of new products with optimal sustained release profiles. About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione's culture is based on innovation, quality and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About Ripple Therapeutics Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple's Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. Ripple's novel therapeutics provide for better outcomes for patients, easier management of care for physicians and lower costs for payors. Ripple has a full product pipeline in development.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

Enanta Pharmaceuticals Receives FDA Fast Track Designation for EDP-323, its Oral, L-Protein Inhibitor in Development

Businesswire | April 10, 2023

Enanta Pharmaceuticals, Inc. a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDP-323, Enanta’s L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV). "Receiving Fast Track designation from the FDA underscores EDP-323’s potential as a once-daily, oral therapeutic for the treatment of this deadly virus and reflects the pressing need for a highly potent, direct antiviral to treat RSV, particularly for high-risk populations,” said Scott T. Rottinghaus, M.D., Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals. “Given that EDP-323 has shown sub-nanomolar potency against several RSV-A and RSV-B strains in vitro and is not expected to have cross-resistance to other classes of inhibitors, we believe it could be used as a monotherapy or in combination with other RSV mechanisms to potentially broaden the addressable RSV patient populations or the treatment window. We believe this designation will be a valuable component of our clinical and regulatory strategy as we progress EDP-323 in development.” The Fast Track program is designed to accelerate the development and review of products such as EDP-323, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation enables more frequent communication with the FDA and eligibility for FDA programs such as priority review and rolling review, if relevant criteria are met. EDP-323 is being evaluated in a Phase 1 double-blind, placebo-controlled study designed to assess its safety, tolerability, and pharmacokinetics (PK). Enanta plans to present new preclinical PK data at the European Congress of Clinical Microbiology and Infectious Diseases in April and expects to report topline data from the Phase 1 study this quarter. EDP-323 is supported by in vitro data demonstrating a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B, with consistent potency across a range of RSV clinical isolates in various cell types. In a mouse model of RSV infection, EDP-323 treatment was associated with dose-dependent decreases in viral load in the lung, reduced lung immunopathology and decreases in pro-inflammatory cytokines, including IFNγ, TNFα, and IL1β. Additionally, EDP-323 has favorable oral bioavailability with good plasma exposures across preclinical species and pharmacokinetic properties supporting once-daily, oral dosing in humans. These data indicate that EDP-323 is a potent inhibitor of RSV replication and has the potential to be a best-in-class, once daily, oral antiviral treatment for RSV. About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections. Enanta’s research and development programs include clinical candidates for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 and hepatitis B virus. Enanta is also conducting research on a single agent targeting both RSV and human metapneumovirus.

Read More

More featured news