AGC Biologics Expands pDNA and mRNA Manufacturing Capacity at Heidelberg Facility

Heidelberg, Germany, Sept. 13, 2021 (GLOBE NEWSWIRE) — AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced expansion plans for the company’s Heidelberg facility to increase manufacturing capacities for plasmid-DNA (pDNA) and messenger RNA (mRNA) projects.

With this expansion, AGC Biologics is boosting its current 100L and 1,000L manufacturing capacities for a variety of different biologics projects by adding an additional GMP manufacturing line. The expansion includes a new GMP cleanroom for mRNA development and manufacturing, a new process development lab for microbial protein and cell and gene therapy (C&GT) projects, and additional warehouse capacity. The expanded capabilities will also allow AGC Biologics to meet the increasing demands of the rapidly growing C&GT market. The facility’s new capabilities will be fully operational in 2023.

“This investment helps strengthen our existing pDNA capabilities and supports our entry into the mRNA space,” says AGC Biologics Chief Executive Officer, Patricio Massera. “With the global pDNA and mRNA markets experiencing record growth, we are focused on ensuring our facilities worldwide offer innovative services that meet the needs of therapeutics developers.”

“These new capacities will help strengthen our Heidelberg facility,” says AGC Biologics Heidelberg Site Head, Dieter Kramer. “We are looking forward to this location having a greater impact on the services AGC Biologics offers to our industry.”

This is the latest in a series of investments AGC Biologics has made this year to expand its offerings and global footprint. The company broke ground on a new multipurpose facility in Copenhagen, Denmark in August that will grow AGC Biologics’ global capacity. The news also comes roughly one month after the company’s successful acquisition of the Longmont, CO. facility, helping the AGC Biologics expand its C&GT capabilities footprint into the United States. Earlier this year, the company expanded its  Cell and Gene Therapy Facility in Milan, Italy as well, adding additional capacity and viral vector suspension capabilities.

About AGC Biologics

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 2,000 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.

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Nick McDonald
AGC Biologics
(425) 419-3555
nmcdonald@agcbio.com

Nyxoah Announces Participation in the Cantor 2021 Virtual Global Healthcare Conference

Nyxoah Announces Participation in the Cantor 2021 Virtual Global Healthcare Conference

Mont-Saint-Guibert (Belgium), September 13, 2021, 10:30 pm CET / 4:30 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that Olivier Taelman, Chief Executive Officer, will participate at the Cantor 2021 Global Healthcare Conference on Tuesday, September 28, 2021, with a virtual presentation at 4:00 pm CET/10:00 am ET.

A live webcast and replay of this event will be available on the Company’s investors relations website at https://investors.nyxoah.com/

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah is seeking for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.

Contacts:
Nyxoah
Fabian Suarez, Chief Financial Officer
fabian.suarez@nyxoah.com
+32 10 22 24 55

Gilmartin Group
Vivian Cervantes
vivian.cervantes@gilmartinir.com

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Minister Pandjaitan outlines three keys for coexistence with pandemic

Coordinating Maritime Affairs and Investment Minister cum Java-Bali PPKM coordinator Luhut Binsar Pandjaitan highlighted three key areas of focus of the government currently for coexistence with the COVID-19 pandemic.

“The first one is the high vaccination coverage, especially for vulnerable groups, such as the elderly,” Pandjaitan stated at an online press conference monitored from here on Monday night.

The second key is the application of Testing, Tracing, Treatment (3T), including optimal handling of centralized isolation places.

“Centralized isolation places are very important. People, who received a black status in the PeduliLindungi application, will be escorted to a centralized isolation. If people looking to enter malls get a black status in the PeduliLindungi application, then they will be taken as well to avoid transmission of the virus,” Pandjaitan stated.

The third important aspect is high adherence to health protocols, including 3M, and the implementation of screening through the PeduliLindungi application, he remarked.

“If the vaccination rate is still low, then the three main strategies will be added with restrictions on community activities, such as implementation of the current PPKM,” Pandjaitan noted.

The deputy chair of the COVID-19 Control and National Economic Recovery Committee (KPC PEN) stated while highlighting President Joko Widodo’s instructions that the objectives and policy directions for handling COVID-19 stayed consistent.

However, strategies and management on the field are adapted to the existing problems and challenges.

“Tightening and easing of community mobility, for instance, must be conducted at the latest every week, with reference to the latest data,” he remarked.

The PPKM tightening and easing measures may often be interpreted as fluctuating or inconsistent policies.

However, that is precisely what is deemed necessary to find the best blend of health and economic interests of the community, he stated.

“This is since the virus is always changing and mutating, for which the handling must also change according to the challenges faced,” the minister noted.

As a former military member, Pandjaitan affirmed that the handling of COVID-19 in Indonesia was no different from military operations.

“Military operations always evolved in an effort to be incognito, to be undetected by our opponent. We read about the nature of this Delta variant, and we also change our strategy to deal with it. That is why we can quickly make improvements in Indonesia,” Pandjaitan added. (INE)

Source: Antara News

Palu lauds Turkish Red Crescent support for school reconstruction

The Palu municipal authority has lauded humanitarian organization Turkish Red Crescent’s assistance in the reconstruction of an elementary school to support the city’s recovery program following the earthquake and tsunami of September 2018.

“Representing Palu authority and residents, I expressed our gratitude for humanitarian assistance from Turkey and other parties involved in our reconstruction effort following the September 28, 2018 earthquake and tsunami disaster,” Deputy Mayor of Palu, Reny A Lamadjido, stated during the handing over ceremony of the Poboya Public Elementary School building in Palu, Central Sulawesi on Tuesday.

She said the completion of the school building would help revive the quality of education and kickstart school activities in the region, which was devastated by the earthquake and tsunami three years ago.

“The Palu authority welcomes all humanitarian organizations who want to participate in the recovery effort for the best interest of the survivors,” Lamadjido said. She said she hoped the Turkish Red Crescent would continue to contribute to other reconstruction and rehabilitation efforts in the city.

She also deemed the organization’s role in recovery efforts as evidence of Indonesian-Turkish friendship.

“The Turkish humanitarian organization did not only participate in school reconstruction, but also provided medical support during the disaster response period after the earthquake,” Lamadjido noted.

Meanwhile, a representative from the Turkish Red Crescent, Teyfik Cem Binatli, said the organization had spent around Rp6.8 billion (around US$476 thousand) on the reconstruction of the Poboya Public Elementary School. Work on the school commenced in 2020.

The facilities at the two-storied school include classrooms, a teachers office, sports facilities, and a prayer room, Binatli said adding, the school building design follows the Turkish architecture style.

“We are glad to see the completion of the building, and we hope the school would provide a safe learning environment for the students,” Binatli remarked.

The Turkish Red Crescent was one of the first responders to assist the Indonesian Red Cross in disaster recovery efforts in Palu, he said. The organization dispatched personnel from its Bangladesh office and provided assistance via two military cargo aircraft, which arrived at the city’s airport on October 9, 2018.

Source: Antara News

West Sumatra holds mass vaccination campaign for 250 thousand students

The West Sumatra provincial government held a mass vaccination campaign to target 250 thousand students of high schools, vocational schools, and education facilities in the area to accelerate the achievement of youth vaccinations.

“The mass vaccination for students aims to accelerate the achievement of youth vaccinations, which are still low in West Sumatra, as well as to make face-to-face learning possible,” West Sumatra Deputy Governor Audy Joinaldy stated at the launch of the program at the State High School 6 Padang on Tuesday.

Currently, the first dose of vaccination for adolescents in West Sumatra reached only around 4.5 percent, while the second dose is even lower, capped at around two percent, he stated.

The provincial and district governments are required to make efforts and offer encouragement in order to accelerate achievement of the youth vaccination rate. One example of this effort is apparent from the vaccination campaign conducted by the West Sumatra provincial government.

After being launched offline at the State High School 6 Padang, all districts and cities in West Sumatra will commence the vaccination program in accordance with the region’s technical readiness.

Joinaldy emphasized that the current vaccine stocks in West Sumatra still sufficed to meet the vaccination requirements, so district and city governments need not harbor concerns, as they can host as many vaccination programs as possible.

“If the stocks in the district or city are falling short, please contact the West Sumatra Health Office directly. We will immediately send it according to the needs,” he clarified.

Joinaldy also compelled vaccinated students to invite their friends to get inoculated too. Thus, face-to-face learning can be recommenced at the earliest.

In fact, he also appealed to parents or guardians of students to participate in vaccination programs with their children in the mass vaccination program.

“Please, parents, who want to be vaccinated, may come along with their children to school to get vaccinated. All will be served by the available officers. If later it turns out that the vaccine is lacking, we will supply it again from the province,” he noted.

Joinaldy expects this step to boost vaccination in Padang, so that the level of community activities restriction would decrease from level 4 and enable students to return to study, albeit with some limitations.

Chairman of Committee V of the West Sumatra Regional House of Representatives Mukhlis Yusuf Abit lauded the West Sumatra provincial government for hosting the vaccination event for these students.

Abit deemed the vaccination as being the most logical effort to control the COVID-19 pandemic, thus calling for it to be supported by various parties.

“The Regional House of Representatives fully supports this program and hopes that the vaccination rate in West Sumatra would increase significantly,” he remarked.

However, he reminded the vaccinated participants to continue to follow health protocols daily to prevent transmission of the virus.

Head of the West Sumatra Education Office Adib Alfikri remarked that all those studying in high school, vocational, and special schools in the province partook in the vaccination for students.

“The implementation of vaccination also requires permission from the parents of the students. We hope that no one refuses, so that the vaccination rate would be achieved as soon as possible, and face-to-face schooling can also be started,” he remarked.

Source: Antara News

Schools in PPKM 1-3 regions urged to commence offline activities

Education, Culture, Research, and Technology Minister Nadiem Makarim urged schools in regions with the activities restrictions enforcement (PPKM) status at levels 1-3 to not hesitate to hold face-to-face offline school activities.

“All schools in regions with the PPKM status at level 1-3 can start offline school activities immediately,” Minister Makarim stated after a meeting with Yogyakarta Governor Hamengku Buwono X in Yogyakarta, Tuesday.

Makarim emphasized that schools should not delay offline learning activities, pending completion of vaccination of teachers and students, as the national vaccination coverage for teachers has reached around 60 percent.

The minister reiterated that vaccination coverage was not considered as an eligibility criterion for schools to commence offline activities. He instead urged schools with vaccinated teachers to start face-to-face offline school activities at the earliest. Despite urging schools to commence offline activities, Minister Makarim reminded that the pupils’ parents had the final say on allowing their children to attend offline activities at school.

“The final decision rests with the parents, and they should not be coerced (to allow their children to attend offline school activities). School should facilitate distance learning if parents are not consenting to send their children to attend offline school,” Makarim stated.

The education minister explained that the joint decision of four ministers on learning activities during the COVID-19 pandemic offered flexibility for the regional authority to plan and implement face-to-face offline school activities in the region.

The joint decision only sets a maximum attendance of 18 pupils in one classroom and a maximum of five pupils per classroom for pre-school level and instructs strict health protocol enforcement, school canteen closure, and restricts extra-curricular activities.

“The joint decision does not restrict or elucidate the school days or hours permitted for offline school activities,” he stated.

Makarim informed that the school is free to utilize the government-provided school operational funding for offline school activities.

“We allowed schools to utilize the fund for preparations to hold offline school activities. We also expect the regional education office heads to consider assisting private schools heavily affected by the pandemic,” Minister Makarim affirmed.

Source: Antara News

Police probing seven Tangerang prison officials over fire

The Jakarta Metropolitan Police are investigating seven officials from the Tangerang Class I Correctional Institution in connection with a fire at the facility last week that left 48 inmates dead.

“We have interviewed the chief warden and head of administration of the correctional institution,” said head of public relations for Jakarta Metropolitan Police, Senior Police Commissioner Yusri Yunus, in Jakarta on Tuesday.

Meanwhile, five other officials are scheduled to be examined by police — the head of the prison’s correctional security unit (KPLP), head of the administration division, head of the legal sub-section, head of the security section, and head of the treatment section, he informed.

Yunus said investigators are currently awaiting the arrival of the five prison officials.

“These are the five that we are still waiting for, there is still time. We hope that there will be five more,” he added.

Head of the Tangerang Class I Prison, Victor Teguh Prihartono, arrived at the General Criminal Investigation Directorate (Ditreskrimum) building of the Jakarta Metro Police around 10:42 a.m. on Tuesday, but he did not speak to reporters and went straight to the investigator’s room.

The Jakarta Metro police had previously sought information from 25 witnesses in connection with the prison fire that broke out on the morning of September 8, 2021 after the status of the case was raised from an examination to an investigation.

Police investigators examined the 25 witnesses at the Jakarta and Tangerang police stations, Yunus informed.

“There were 12 people questioned by the Jakarta Metro Police, including prison employees who were on duty that night. We examined them and the BAP (minutes of investigation), then there were three witnesses from the electricity company PLN,” he said.

The witnesses examined at the Tangerang City Metro Police comprised three firefighters who were in charge of extinguishing the fire and seven inmates, he added.

Source: Antara News

APEC to hold forum on women’s empowerment on Sep 24

Ministers and senior leaders from APEC (Asia-Pacific Economic Cooperation) member countries are scheduled to meet on September 24, 2021 to discuss and advance gender equality and women’s economic empowerment across the APEC region.

This year’s Women and the Economy Forum will take place against the unique and devastating backdrop of COVID-19, according to an APEC release.

A more inclusive post-COVID world is the goal of the 21 APEC ministers and senior leaders who will meet at the forum, it said.

A recent report has shown that women have been hit the hardest by the economic impacts of the COVID-19 pandemic, it added.

According to a report by McKinsey & Company, women made up 39 percent of global employment, and yet, they accounted for 54 percent of overall job losses due to the COVID-19 pandemic.

The disproportionate impact of the pandemic has made it clear that APEC economies are currently not resilient or inclusive enough, according to the press release.

Therefore, this year’s forum will present a unique opportunity to ensure that APEC members rebuild economies to be more inclusive, locking in the work APEC has set out to achieve in the La Serena Roadmap, it said.

The La Serena Roadmap was developed in 2019 to provide concrete direction and to catalyze policy actions across APEC to drive “greater inclusive economic development and participation of women in the Asia-Pacific”, it added.

At the APEC Women and the Economy Forum, ministers and senior leaders will re-visit the La Serena Roadmap, it said.

The roadmap runs till 2030 and contains defined action areas and targets ranging from laws and policies to prohibit discrimination on the basis of sex to improving the region’s gender balance in leadership positions.

The Women and the Economy Forum will culminate in a ministerial statement, which will underscore the need to accelerate efforts towards women’s economic empowerment to aid recovery and highlight important steps being taken across the region to achieve this end, the press release informed.

Source: Antara News