BioNet

BioNet‑Asia กับภารกิจพาวัคซีนสัญชาติไทยสู่การยอมรับระดับสากล

เคยมีช่วงเวลาที่การพัฒนา “วัคซีน” ในประเทศไทยถูกมองว่าเป็นเรื่องไกลเกินเอื้อม ไม่ใช่เพราะคนไทยไม่เก่ง แต่เพราะระบบและทรัพยากรไม่เอื้ออำนวย แต่ BioNet‑Asia คือหนึ่งในองค์กรที่พิสูจน์ว่า ความเชื่อ + ความมุ่งมั่น + วิทยาศาสตร์ สามารถเปลี่ยนข้อจำกัดให้กลายเป็นโอกาสได้จริง

จุดเปลี่ยนสำคัญของอุตสาหกรรมวัคซีนไทย BioNet‑Asia เป็นผู้พัฒนาและผลิตวัคซีนด้วยเทคโนโลยีขั้นสูง ตั้งแต่ต้นน้ำถึงปลายน้ำในประเทศไทย ประสบความสำเร็จในการสร้างวัคซีนสัญชาติไทยที่ได้รับการยอมรับในระดับโลก ลดการพึ่งพาการนำเข้า และยกระดับความมั่นคงทางสุขภาพของประเทศ

จาก Local Solution สู่ Global Impact สิ่งที่ BioNet‑Asia ทำ ไม่ได้หยุดแค่ “การผลิตวัคซีน” แต่คือการสร้างระบบนิเวศนวัตกรรมที่เชื่อมโยงนักวิทยาศาสตร์ภาคการแพทย์ และมาตรฐานสากลเข้าด้วยกัน นี่คือบทเรียนสำคัญว่านวัตกรรมระดับโลก สามารถเริ่มต้นได้จากประเทศไทย หากมีวิสัยทัศน์และความเชื่อที่ชัดเจน

เรื่องราวของ BioNet‑Asia จึงไม่ใช่แค่ความสำเร็จของบริษัทหนึ่ง แต่คือแรงบันดาลใจของนวัตกรรมไทยบนเวทีโลก

อ่านเรื่องเต็มได้ที่ THE STANDARD

ถอดบทเรียน BioNet-Asia ผู้ทลายขีดจำกัด สู่ วัคซีนไทย ตัวแรกที่โลกยอมรับ ถอดกลยุทธ์ความสำเร็จของ BioNet-Asia ในงาน National Thai FDA Forum 2026 โดย วิฑูรย์ วงศ์หาญกุล กับการพัฒนาวัคซีนไอกรนชนิดไร้เซลล์

New Pertussis Vaccine Set for Implementation

The Committee for Medicinal Products for Human Use (CHMP), a part of the European Medicines Agency (EMA), recently recommended approval of a pertussis vaccine for teenagers, adults and newborns.

According to the agency, VacPertagen could serve as an effective pertussis booster vaccine for kids aged 12 and above, helping prevent diagnoses of whooping cough. It could also offer passive protection to infants when administered to pregnant women in their 2nd or 3rd trimesters.

This is because the vaccine uses a blend of two refined pertussis antigens - recombinant pertussis toxin (PTgen) and filamentous haemagglutinin (FHA).

Currently available as prefilled syringes, this vaccine can trigger pertussis antibody responses in individuals with a single intramuscular injection.

The EMA has greenlighted the use of this vaccine following the success of its clinical trials.

The studies showed that VacPertagen could trigger an antibody response within 28 days of administration. This period remained the same even when the vaccine was administered to pregnant women in their second and third trimesters, after which they were transferred through the placenta to the newborns.

They also highlighted that the vaccine provided antibody persistence for up to 3 years in adults and 5 years in adolescents.

No serious safety concerns were identified in the trials. Reported side effects were mild and consistent with common vaccine reactions, such as injection-site pain, headache, nausea and fatigue.

With the CHMP’s positive opinion, the vaccine now awaits formal marketing authorisation. Rollout decisions will follow regional regulatory approvals and vaccination guidelines.

Source: https://www.hdfcergo.com/news/health-insurance/new-pertussis-vaccine-set-for-implementation

BioNet Achieves EU-GMP Certification for its Pertussis Vaccine Manufacturing

Lyon, France – October 29, 2025, BioNet today announced it has received European Union Good Manufacturing Practice (EU-GMP) certification, an internationally recognized benchmark of pharmaceutical quality and compliance, to produce its acellular pertussis vaccine.

“This milestone underscores BioNet’s resolute dedication to world-class manufacturing standards and marks a key step in the ongoing centralized regulatory review of its recombinant acellular pertussis vaccine candidate, VacPertagen, by the European Medicines Agency (EMA).” said Philippe Guillot-Chêne, CEO, BioNet in Europe.

The EU-GMP certification confirms that BioNet’s facilities, quality systems and quality controls meet the highest international criteria.

“The certificate was received following the inspection of BioNet production site by the Ireland Health Products Regulatory Authority (HPRA).” added Dario Cresci, Director Quality. “This achievement reflects BioNet’s long-standing culture of excellence and commitment to provide public health authorities with innovative solutions to the global pertussis resurgence.”

About BioNet
BioNet is a pioneering biotechnology group that specialises in the development of next-generation vaccines. Leveraging its expertise in translational research and its GMP production facilities, BioNet is today the leading global manufacturer of recombinant pertussis vaccines. For 25 years, BioNet has fostered multiple partnerships to accelerate access to technology and to increase and expand global vaccine capability.

BioNet’s pertussis vaccine is licensed under Pertagen® tradename in Asia and has been submitted under VacPertagen name to EMA centralized procedure by BioNet in France.

Contact
Mr Philippe Guillot-Chêne, BioNet, France.
Tel: +33 4 81 49 46 00
[email protected]
www.bionet.one

Press Release: BioNet and Bio Farma Sign Strategic MoU to Expand TdaP Vaccine Access in ASEAN

Jakarta, May 28, 2025 — BioNet, a Franco-Thai vaccine biotech group, and PT Bio Farma (Persero), Indonesia’s state-owned vaccine manufacturer, have signed a Memorandum of Understanding (MoU) to collaborate on the development and regional distribution of a combined TdaP vaccine (tetanus, diphtheria, and acellular recombinant pertussis).

Signed during the State Visit of French President Emmanuel Macron to Indonesia, the agreement underscores a shared commitment to accelerating access to innovative vaccines across Southeast Asia. The partnership combines BioNet’s proprietary recombinant pertussis technology and global clinical development experience with Bio Farma’s large-scale manufacturing capabilities and public health reach to address critical immunization needs in ASEAN.

“This agreement reflects our shared vision to make next-generation vaccines more accessible where they are most needed,” said Philippe Guillot-Chêne, CEO of BioNet Europe. “By aligning our strengths, BioNet and Bio Farma are helping to build a stronger regional health ecosystem and reinforce ASEAN’s capacity to respond to both current and emerging infectious disease threats.”

The MoU outlines cooperation in clinical development, regulatory alignment, and market access strategies. Bio Farma will conduct clinical trials and manage regulatory submissions in Indonesia, while BioNet will do so in other ASEAN countries.

The collaboration aims to accelerate vaccine availability by reducing the time gap in introducing innovative vaccines to the region—from 10–15 years down to less than five.

“Through this collaboration, we are reinforcing Indonesia’s commitment to regional vaccine self-sufficiency and innovation,” said Yuliana Indriati, Director of Business Development at Bio Farma. “With BioNet’s advanced recombinant pertussis technology and our production capacity, we aim to ensure timely access to TdaP vaccines for Indonesian adolescents, pregnant women, and the elderly. We hope this product will soon be part of our national immunization program.”

The TdaP vaccine developed under this partnership will leverage antigens contributed by both parties—Td from Bio Farma and aP from BioNet. The combined product is targeted for use across ASEAN, with a potential market of 10–15 million doses annually, valued at around USD 200 million.

This collaboration is expected to help strengthen regional pandemic preparedness, build resilient vaccine supply chains, and promote equitable health access across Southeast Asia.
This step is in line with President Prabowo Subianto’s Asta Cita, particularly the goals of realizing national self-reliance in the fields of economy, food, and energy, as well as improving the quality of life of the people and expanding access to affordable and high-quality healthcare services.

About BioNet
BioNet is a French-Thai vaccine organization developing and manufacturing genetically designed vaccines with a global footprint. The group includes:
• BioNet Europe, a fast-growing French biotech company which has recently submitted an EU-GMP certified recombinant pertussis vaccine application to the European Medicines Agency (EMA) for centralized approval.
• BioNet Asia, a leading vaccine company based in Thailand, producing and marketing a range of vaccines that include the world’s only recombinant pertussis standalone vaccine.
BioNet has also developed a clinically-proven, end-to-end mRNA production process, enabling multiple collaborations with leading organizations and academic institutions worldwide to promote technology transfer, regional manufacturing, and pandemic preparedness.

About Bio Farma
PT Bio Farma (Persero) is Indonesia’s largest state-owned pharmaceutical holding company, operating in the healthcare sector with integrated end-to-end services — ranging from pharmaceutical research and development, manufacturing, and distribution to retail pharmacy operations, clinics, and clinical laboratories.To support its business operations, Bio Farma operates a head office and manufacturing facility in Bandung, West Java, which includes office buildings and production facilities. The company also maintains a representative office in Jakarta. With an annual production capacity of over 3.2 billion doses of vaccine, Bio Farma exports its products to more than 150 countries worldwide. It serves as the parent company of two publicly listed pharmaceutical companies on the Indonesia Stock Exchange (IDX): PT Kimia Farma Tbk (KAEF) and PT Indofarma Tbk (INAF). For more information, please visit: www.biofarma.co.id.

https://bionet.one/bionet-and-bio-farma-sign-strategic-mou-to-expand-tdap-vaccine-access-in-asean/