In recent years, exponential growth in medical innovation and scientific advancement has been seen. Current medical practices are being revolutionized by biomedicines and advanced therapy medicinal products (ATMPs), made up of gene and cell therapies and tissue engineered products. These are speeding up our ability to treat previously incurable and untreatable diseases and medical conditions.
Need for Appropriate Regulatory Guidance
Current regulatory frameworks are not fully equipped to enable standardized review of such novel and complex medicines, due to their unprecedented speed of development. Therefore, the regulatory agencies are learning in line with product development, and constructing knowledge bases via interactions with ATMP applicants to produce the appropriate regulatory guidance.
ATMP Manufacturers’ Concerns
The diversity within the field of advanced therapies makes the lack of understanding and clarity on how to regulate such products extremely problematic. Lack of control over CMC aspects is a major concern for ATMP developers; this includes the ability to create these complex products in a way that adheres to traditional CMC expectations suited to small molecule chemical entities.
ATMP manufacturers cannot typically exhibit a historically accepted level of product quality and control during manufacture, unlike manufacturers of the latter. Although this may be completely justified because of the small-scale development of ATMPs or the intricate and novel techniques and/or environment needed for their manufacture and development, there is still a major concern as to how to regulate these products appropriately.
Utilizing raw materials and excipients (both functional and non-functional) which possess a level of quality, efficacy and safety wherever possible is one way to mitigate against some of the CMC concerns during ATMP development.
This can help to ease regulators’ concerns by exhibiting that the final product, although complex and novel, is partially made of components which possess a proven safety profile, are produced in GMP environments or are well-established, further showing the developer’s commitment to quality.
Albumedix’s Recombinant Albumins
Albumedix’ recombinant albumin products can provide a solution to developers who are looking to source GMP compliant raw materials and/or excipients which have been utilized for a number of years with known safety and efficacy profiles.
Image credit: Albumedix
This product portfolio possesses well-known safety profiles with extensive supporting clinical and non-clinical data (Recombumin® Prime, Recombumin® Elite has supporting non-clinical data only). Furthermore, comprehensive regulatory support is available, which could help to alleviate the regulatory burden of product development.
Recombumin® Prime has a large volume of supporting regulatory documentation which has been recognized in its own right by a number of world-leading authorities including Health Canada, FDA (US), TGA (Australia), and Medsafe (New Zealand), in addition to being thoroughly scrutinized as part of their clients’ overall BLA, MAA, IND, CTA, and NDA applications over a worldwide platform. Recombumin® Elite also has a comprehensive regulatory package, recognized by the FDA (US).
Albumedix’ fully eCTD compliant regulatory documentation has been examined at numerous stages of clients’ development programs from early phase, through to final product applications.
Assuring the product quality further, Recombumin® Prime also has a USP-NF compendial status. So, there is a regulatory precedence for Albumedix’ albumins because of their well-established quality standards and regulatory relationships.
Regulatory authorities are familiar with the products and consequently may be more comfortable in the utilization of these as part of ATMP development, especially when implemented further down-stream closer to the patient.
Regulatory Experts at Albumedix
Albumedix has a team of dedicated regulatory experts who can support ATMP developers throughout their program, assisting with regulatory strategy in addition to the routine provision of regulatory documentation to support the utilization of their products.
Furthermore, they provide support throughout agency reviews, including the generation of responses to questions on their albumins, attendance at regulatory agency meetings plus supplying specific albumin product advice as needed.
Albumedix manufactures recombinant albumin products developed specifically for use in medicinal products. Thus, these are controlled by stringent standards and rigorous processes to create the highest quality recombinant albumins available.
They have compared the critical quality attributes of their products with other commercial human albumins and have proven that they are more consistent, purer, and of superior product quality overall. These findings are supported by continued internal data generation, their GMP-grade manufacturing environment, and a comprehensive, robust, supporting regulatory package of information. This is in addition to external validation of these claims, ranging from regulatory authorities1 to collaboration customers and partners.
Benefits of Albumedix Recombinant Albumins
Manufacturing issues are regularly being reported as challenges for developers of gene and cell therapy products, recognizing issues like product variability and control over the manufacturing process as significant hurdles to overcome. Albumedix’ albumins possess a consistent profile with extremely low variability, so incorporating these within the final product manufacture will also decrease variability issues.
In addition, sales expectations will grow exponentially as acceptance for advanced therapies grows; meaning that manufacturers will be required to scale-up processes accordingly and manufacture in commercial-grade environments. Since Albumedix already manufactures commercial grade material at their UK GMP facility, incorporating their formulations into the final drug products may facilitate scale-up problems.
Keeping Up Quality Standards
Albumedix’ manufacturing facility is regularly inspected by the UK Regulatory Authority, MHRA, in addition to clients’ external, and their own internal audits, in order to keep up quality standards. Product quality is key, which is shown throughout their regulatory documentation. Albumedix’ albumins exhibit proven product quality and consistency, minimizing the risk of inter-batch variability.
This is vital for ATMP development as the slightest alteration in overall product could lead to a considerable impact to the end-user. Therefore, utilization of Recombumin® products removes the variability concerns related to the employment of more heterogeneous HSA or other non-recombinant albumin products. Utilization of Albumedix’ albumins is also in compliance with the EU guidelines on the plasma-derived albumin guideline.
Reducing Risk
Employing a product with well-established regulatory support and acceptance from the authorities could help to streamline the overall application review and approval processes by decreasing the risk of significant specific albumin-use related questions.
Lastly, all Albumedix’ albumins are free of animal- and human-derived materials entirely, with supporting TSE/BSE certification, removing the risk of variability and contamination in addition to concerns over safety for human/animal-derived products.
Using animal and human free products is also beneficial for wider target audiences, with growing concerns over the utilization of animal products and an increase in religious and dietary needs demanding the removal of animal-derived products from medicines.
1Frahm GE, Smith DG, Kane A, et al. Determination of supplier-to-supplier and lot-to-lot variability in glycation of recombinant human serum albumin expressed in Oryza sativa. PLoS One. 2014;9(10):e109893
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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