Top Hemgenix Manufacturers Revolutionizing Gene Therapy

Are you struggling to find the best Hemgenix manufacturer for your needs? With so many options out there, it can feel overwhelming to sift through the choices. The right supplier can make all the difference in quality and efficiency, ensuring you get the best product for your investment. Imagine the peace of mind that comes from partnering with a top-tier factory—one that meets rigorous standards and delivers consistently.

The benefits of choosing the right manufacturer are immense: superior quality, faster turnaround times, and reliable support. Ready to discover the top 30 Hemgenix manufacturers that can elevate your project? Dive into our comprehensive guide and unlock the insights you need to make an informed decision!

Top 21 Hemgenix Manufacturer Manufacturers

Hemgenix – Gene Therapy for Hemophilia B

Domain: hemgenix.com

Registered: 2019 ( 6 years )

Introduction: Hemgenix is a gene therapy product designed for the treatment of Hemophilia B, a genetic disorder that affects blood clotting.

CSL Behring – Hemophilia Treatment Solutions

Domain: medicalaffairs.cslbehring.com

Registered: 2006 ( 19 years )

Introduction: HEMGENIX® is a product offered by CSL Behring for the treatment of hemophilia.

Uniqure – Gene Therapy for Hemophilia B

Domain: uniqure.com

Registered: 2011 ( 14 years )

Introduction: HEMGENIX (etranacogene dezaparvovec) is the world’s first gene therapy for hemophilia B, approved by the FDA in November 2022 and received conditional marketing authorization from the European Commission in February 2023.

Hemoalliance – Hemgenix Gene Therapy for Hemophilia B

Domain: hemoalliance.org

Registered: 2004 ( 21 years )

Introduction: Hemgenix is a gene therapy product designed for the treatment of hemophilia B.

Newsroom – Gene Therapy for Hemophilia B

Domain: newsroom.csl.com

Registered: 1997 ( 28 years )

Introduction: HEMGENIX® (etranacogene dezaparvovec-drlb) is the first and only one-time gene therapy approved for adults with hemophilia B, enabling the body to produce factor IX and reducing the need for prophylactic therapy.

Icer – Gene Therapies for Hemophilia

Domain: icer.org

Registered: 1999 ( 26 years )

Introduction: Gene therapies for hemophilia A and B, specifically Roctavian (valoctocogene roxaparvovec) for hemophilia A and Hemgenix (etranacogene dezaparvovec) for hemophilia B.

Clinical Therapeutics – Gene Therapy for Hemophilia

Domain: clinicaltherapeutics.com

Registered: 2000 ( 25 years )

Introduction: Information not available.

Empr – Gene Therapy Solutions

Domain: empr.com

Registered: 1999 ( 26 years )

Introduction: Hemgenix is an adeno-associated virus vector-based gene therapy designed to deliver a copy of a gene encoding the Padua variant of human coagulation Factor IX.

CSL Behring – Gene Therapy for Hemophilia B

Domain: cslbehring.de

Registration year: Not available

Introduction: CSL Behring has launched a gene therapy for Hemophilia B, aimed at providing innovative treatment options for patients with this hereditary bleeding disorder.

Prnewswire – Gene Therapy Solutions

Domain: prnewswire.com

Registered: 1995 ( 30 years )

Introduction: Hemgenix (etranacogene dezaparvovec-drlb) is an FDA-approved gene therapy for hemophilia B.

Biologics HQ – Gene Therapy for Hemophilia B

Domain: biologicshq.com

Registered: 2015 ( 10 years )

Introduction: Hemgenix® (etranacogene dezaparvovec-drlb) is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with Hemophilia B (congenital Factor IX deficiency).

340Breport – Hemophilia B Gene Therapy Solutions

Domain: 340breport.com

Registered: 2019 ( 6 years )

Introduction: Hemgenix is the first gene therapy approved by the FDA for the treatment of adults with hemophilia B, enabling patients to produce their own factor IX.

Buyandbill – Gene Therapy Solutions

Domain: buyandbill.com

Registered: 2011 ( 14 years )

Introduction: Hemgenix is a gene therapy product indicated for the treatment of certain hematological conditions, administered via intravenous injection.

Fierce Pharma – AAV Vector Gene Therapy Services

Domain: fiercepharma.com

Registered: 2007 ( 18 years )

Introduction: Gene therapy manufacturing services, specifically focusing on the production of adeno-associated virus (AAV) vectors.

CSL – Plasma Therapies and Vaccines

Domain: csl.com

Registered: 1997 ( 28 years )

Introduction: CSL Behring offers a broad range of quality plasma-derived and recombinant therapies, while CSL Seqirus is one of the world’s largest providers of influenza vaccines.

Everyday Health – Gene Therapy for Hemophilia B

Domain: everydayhealth.com

Registered: 2004 ( 21 years )

Introduction: Hemgenix (etranacogene dezaparvovec) is a gene therapy approved for the treatment of adults with hemophilia B, specifically targeting those who currently use factor 9 prophylaxis therapy or have a history of life-threatening bleeding episodes.

Hemob – Gene Therapy for Hemophilia B

Domain: hemob.org

Registered: 2016 ( 9 years )

Introduction: HEMGENIX® (etranacogene dezaparvovec-drlb) is the first and only one-time gene therapy approved for adults with hemophilia B, enabling the body to produce factor IX and reducing the need for prophylactic therapy.

Medicines – Gene Therapy for Haemophilia B

Domain: medicines.org.uk

Registered: 1999 ( 26 years )

Introduction: Hemgenix 1 x 10 13 genome copies/mL concentrate for solution for infusion, containing etranacogene dezaparvovec, used for the treatment of severe and moderately severe Haemophilia B.

Tga – Gene Therapy for Hemophilia B

Domain: tga.gov.au

Registration year: Not available

Introduction: Hemgenix (etranacogene dezaparvovec) is a gene therapy product developed for the treatment of hemophilia B.

Biopharma Dive – Gene Therapy Solutions

Domain: biopharmadive.com

Registered: 2013 ( 12 years )

Introduction: Hemgenix is the first gene therapy approved for hemophilia B, developed by UniQure and marketed by CSL.

Odelletechnology – Hemgenix Gene Therapy Solutions

Domain: odelletechnology.com

Registered: 2012 ( 13 years )

Introduction: Hemgenix gene therapy for hemophilia B treatment.

Category Information

Hemgenix is a groundbreaking gene therapy developed for the treatment of hemophilia B, a genetic disorder that impairs the blood’s ability to clot. The manufacturer of Hemgenix, which is pivotal in this field, focuses on advanced biopharmaceuticals and innovative therapies that leverage genetic engineering to address rare and complex diseases. This category includes companies dedicated to the research, development, and commercialization of therapies that can modify or correct genetic defects.

The significance of Hemgenix’s manufacturing lies in its potential to transform the lives of patients suffering from hemophilia B by providing a long-lasting treatment option rather than the traditional, frequent factor replacement therapies. By delivering a functional copy of the gene responsible for producing the clotting factor, this therapy can significantly reduce bleeding episodes, improve quality of life, and decrease healthcare costs associated with ongoing treatment.

As such, the role of manufacturers in this category is crucial for advancing medical science and improving patient outcomes.

Application Information

Hemgenix, a gene therapy product developed for hemophilia B, has significant applications in the healthcare industry, particularly in the treatment of genetic disorders. One key application area is gene therapy, where Hemgenix provides a long-term solution for patients suffering from hemophilia B by delivering a functional copy of the F9 gene, which is crucial for blood clotting. This innovative approach reduces the frequency of bleeding episodes and decreases the need for regular factor replacement therapy.

Another important area is specialized care for rare diseases, where Hemgenix exemplifies advancements in treating conditions that historically lacked effective therapies. Additionally, it finds relevance in patient management programs, where healthcare providers monitor and support patients receiving gene therapy, ensuring optimal outcomes. Overall, Hemgenix represents a transformative shift in the treatment of hemophilia B, highlighting the growing importance of genetic therapies in modern medicine.

Production Process Information

Hemgenix is a groundbreaking gene therapy used to treat hemophilia B, a genetic disorder that affects blood clotting. The production process for Hemgenix involves several key stages. First, the manufacturing begins with the design of the viral vector, which is a modified virus that carries the therapeutic gene. This step is crucial, as the vector must be safe and effective in delivering the gene to the patient’s cells.

Next, the vector is produced in large quantities using specially engineered cells in bioreactors. Once the vector is produced, it undergoes purification and quality control to ensure it meets safety and efficacy standards. Finally, the prepared therapy is packaged and distributed to healthcare providers, where it can be administered to patients. Throughout this process, strict regulatory oversight ensures that Hemgenix is safe for use.

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Frequently Asked Questions (FAQs)

What should I consider when looking for a Hemgenix manufacturer?
When searching for a Hemgenix manufacturer, it’s important to consider their experience and expertise in biopharmaceutical production, particularly with gene therapies. Look for manufacturers that have a proven track record in handling similar products and comply with regulatory standards like FDA or EMA. Additionally, consider their capacity to scale production according to your needs, their quality control processes, and their ability to provide comprehensive support throughout the manufacturing process.

How can I verify the credibility of a Hemgenix manufacturer?
Verifying the credibility of a Hemgenix manufacturer involves a few key steps. Start by checking their certifications and accreditations, such as Good Manufacturing Practice (GMP) compliance. You can also request references from previous clients and look for case studies or testimonials that highlight their success in similar projects. Furthermore, visiting the facility, if possible, can provide insights into their operations and quality assurance practices.

What are the typical costs associated with manufacturing Hemgenix?
The costs of manufacturing Hemgenix can vary widely based on several factors, including the scale of production, the complexity of the formulation, and the specific services required (like packaging or labeling). It’s essential to obtain detailed quotes from multiple manufacturers, which should break down costs for production, testing, and any additional services. Keep in mind that while it’s tempting to go for the cheapest option, quality and reliability should also be top priorities to avoid future issues.

How important is communication when choosing a Hemgenix manufacturer?
Communication is crucial when selecting a Hemgenix manufacturer. A manufacturer that maintains clear, open lines of communication will help ensure that your project runs smoothly and that any issues are addressed promptly. Look for a partner that is responsive to your inquiries and willing to engage in regular updates throughout the production process. This collaborative approach can lead to better outcomes and a more successful partnership overall.

What role does regulatory compliance play in choosing a Hemgenix manufacturer?
Regulatory compliance is a fundamental aspect of choosing a Hemgenix manufacturer. It ensures that the products are manufactured according to the highest safety and efficacy standards, which is vital in the biopharmaceutical industry. Make sure the manufacturer you choose has a solid understanding of the regulatory landscape and can demonstrate compliance with relevant guidelines. This not only protects patients but also helps in avoiding costly delays in product approval and market entry.

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