Recombumin® is the highest quality animal and human-free recombinant human albumin (rAlb) commercially available. Recombumin is manufactured using Albumedix’ proprietary Saccharomyces yeast strains, in a dedicated, purpose-built cGMP certified facility in the UK and maintains 25+ years of ICH Q7 GMP compliance.
With over 25 years production experience and 30 years working with albumin, Albumedix’ facilities are certified by MHRA (UK) and are subject to routine external audits to maintain the highest possible quality standards. We are still as passionate about albumin and albumin-enabled therapies today as we were 30 years ago.
What is GMP compliance?
GMP stands for 'Good Manufacturing Practice'. For a manufacturer to be certified as a GMP producer, they have to have demonstrated a robust compliance system, traceable and reproduceable manufacturing procedures underpinned by a comprehensive quality management system and a demonstrated commitment to international GMP standards.
These practices are required to conform to internationally recognised standards and recommended guidelines and are enforced by agencies that have the ability to control the licensing and authorization of the sale and manufacture of pharmaceuticals and medical devices.
These practices underline the recommended requirements to ensure that products are effective, pure and safe, as well as limiting the instances of errors and contamination. Manufacturers should be seen to take a proactive approach to implementing these guidelines at all stages of manufacture.
There are varying rules that apply to different industries; however, they all have a common theme of protecting the end user from harm. Many of the common GMP include having robust quality assurance checks, ensuring staff are appropriately trained, and a well-documented manufacturing process.
What is the ICH Q7 Guideline?
The ICH Q7 guideline is specifically designed for the good manufacturing practice of active pharmaceutical ingredients. This international agreement aims to standardize the manufacturing and quality assurance of pharmaceutical ingredients to ensure the requirements of purity and quality are met.
ICH Q7 is applicable to all operations related to the manufacturing and production of any product with active pharmaceutical ingredients, including the receipt of raw materials and the manufacture, quality control, packaging, labelling, storage and release of final product.
With decades of manufacturing capability and experience, Albumedix has produced an optimized process to produce a very pure and highly consistent albumin product, while adhering to GMP and ICH Q7 standards.
Benefits to the customer include:
Pharmaceutical manufacturers know what they are adding to their active pharmaceutical ingredients every time due to high batch-to-batch consistency.
With a recombinantly produced product, manufactured at Albumedix’ own manufacturing site in Nottingham UK to ICH Q7 GMP standards, security of supply, batch-to-batch consistency and quality is much stronger than Human Serum Albumin (HSA) which is reliant on consistent blood donations and availability after clinical requirements.
- ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients: https://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.html
About Albumedix Ltd.
Too many people battle with diseases that keep them from living a full life. Healthcare professionals work hard every day to provide these people with better therapies. Together with partners, Albumedix utilize its albumin-based drug enhancing products and technologies to enable the development of more effective treatments.
With more than 30 years of experience, we are proud to be recognized as the world leader in recombinant human albumin products and technologies.
As the highest quality recombinant human albumin products ever developed, Albumedix enables the effective formulation of otherwise hard-to-stabilize drugs, cell therapies, and vaccines.
Our albumin-based technologies offer new ways of optimizing drug dosing and enhancing therapeutic performance by increasing the half-life, payload capacity, and tissue specific delivery of active pharmaceutical agents. This results in simpler treatment regimens, better performance, and, ultimately, improved patient outcomes.
Albumedix is headquartered in Nottingham, UK, with both research and large-scale manufacturing facilities. We are all committed to improving patient quality of life and are just as passionate about albumin and albumin-enabled therapies today as we were when we started 30 years ago.
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