How Is Recombinant Albumin Streamlining Gene Therapy?

Highlights

• Introduction
• Growth of the Asia-Pacific albumin industry
• Applicability of albumin in gene therapy
• Recent developments in the industry

Albumin is a water-soluble protein synthesized by the liver and present in blood plasma. Albumin is essential for regulating osmotic pressure and transporting various substances, including hormones, drugs, and nutrients. Its molecular structure allows it to bind with a wide range of molecules. This multifunctional protein helps maintain fluid balance, preventing edema, and supports the distribution of crucial compounds throughout the body. Serum albumin levels are often measured clinically to assess nutritional status and liver function.

The albumin industry is expanding due to increased efforts to promote blood donation awareness. As these awareness campaigns advance, the supply of human plasma, a primary source of albumin, is positively impacted. Additionally, the growing use of albumin in drug development is highlighting its potential. Albumin's versatile properties make it an integral ingredient in pharmaceutical formulations, improving drug stability and delivery. The pharmaceutical industry's emphasis on creating innovative medications further heightens the demand for albumin. 

Expanding Landscape of the Asia-Pacific albumin industry

The rising prevalence of chronic conditions such as liver failure, respiratory distress, and ovarian abnormalities is boosting the demand for albumin in treatments across the Asia-Pacific region. Albumin is an integral component in drug delivery, drug formulation, medical device coatings, vaccines, diagnostics, in vitro fertilization, and culture media and stabilizers.

Moreover, increasing healthcare investments and a growing demand for biopharmaceuticals in emerging economies such as China and India are strengthening the position of the Asia-Pacific region in the albumin industry. Biopharmaceutical companies are leading the development of new therapeutic solutions that utilize albumin, especially recombinant albumin. Their investment in research and development is essential for creating innovative drugs to treat conditions such as hypoalbuminemia and other chronic diseases, which, in turn, drives the demand for albumin products. Among the emerging economies across the Asia-Pacific, China is expected to witness the fastest growth with 7.8% CAGR throughout the forecast timeframe. 

Enhancing therapeutic outcomes with recombinant albumin

Albumin is utilized as a second-line treatment for fluid resuscitation in patients with hypovolemia when there is insufficient response to crystalloids. It is utilized in the treatment of volume expansion, shock, burns, and other medical conditions that require plasma-derived therapy or protein supplementation. The high incidence of burns, along with advancements in burn care enhancing survival rates, drive a consistent demand for albumin.

There is a growing shift toward using recombinant albumin to address safety concerns related to plasma-derived sources. Recombinant technologies offer an improved safety profile for albumin-based products by allowing for a more controlled and scalable production process. Recombinant albumin is essential for creating high-quality cell culture media and for the growth and maintenance of cells used in gene therapy. It ensures a controlled environment that supports cell health and productivity, leading to the generation of high-yield therapeutic products.

Albumin's antioxidant properties help neutralize free radicals, reducing oxidative stress in cell cultures. This feature is valuable in gene therapies, where maintaining cellular integrity is important for achieving successful outcomes.

Bio Products Laboratory announced the launch of ALBUMINEX® 25% and ALBUMINEX® 5%

A leading manufacturer of plasma-derived protein therapies, Bio Products Laboratory (BPL), announced the US launch of ALBUMINEX 25% and ALBUMINEX 5% in May 2020. Both products are human albumin solutions for injections and are now available for supply. ALBUMINEX 5% and ALBUMINEX 25% are indicated for the treatment of cardiopulmonary bypass, ascites, hypovolemia, hypoalbuminemia (including from burns), acute respiratory distress syndrome (ARDS), and acute nephrosis.

Shilpa Biologic got approval to conduct a Phase 1 study on NavAlbumin

Shilpa Medicare, through its subsidiary Shilpa Biologicals, received approval from the Central Drugs Standard Control Organisation (CDSCO) in November 2021 to conduct a Phase I human clinical study on its flagship novel product, recombinant Human Albumin (NavAlbumin). The product, NavAlbumin, is synthetically developed and it has been granted a global patent.  Shilpa Medicare is actively enhancing its patent protection around the product to safeguard it from potential competition.

To conclude, the albumin industry is experiencing significant growth driven by increased blood donation awareness and its expanding use in pharmaceuticals. The Asia-Pacific region is leading this expansion, fueled by rising chronic disease rates and biopharmaceutical investments. Furthermore, innovations such as recombinant albumin and new product developments are estimated to enhance albumin’s therapeutic applications and advance the industry’s scope and effectiveness.

For additional details on the various uses of albumin and driving forces of industry growth, contact our experts today!

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