Alpha Biologics
"Pioneering biologics to advance tomorrow’s therapies"
Facility Design
The Alpha Biologics facility was designed by a team that collectively has been responsible for numerous cGMP compliant facilities, many of which have undergone successful FDA / EMEA audits and are fully approved facilities. This experience also extends to facilities designed with the same principle in mind as the Alpha facility, i.e. the manufacture of biologic drugs for clinical trials.
The Alpha Biologics facility design has been reviewed by the FDA and declared suitable for both clinical trial and early market product manufacture.
The Alpha facility incorporates a process development facility that enables our process development specialists to adapt or modify our clients' processes to cGMP compliant manufacture. It also enables Alpha Biologics to offer services to completely develop your process from early research phase.
The cGMP facility includes three separate Isolation Suites that enable our staff to initiate work with your product / cell line prior to the cell line being confirmed as fully characterised and ready for suitable for the production of clinical grade drug. This includes the development of Master and Manufacturing Working Cell banks and small scale product manufacture for use in pre-clinical studies.
About Us
Alpha Biologics is a Contract Manufacturer of Biologics drugs for use in pre-clinical, Phase1 and 2 clinical trials, anywhere in the World.
The life sciences industry is experiencing spiralling drug development costs that are making it increasingly difficult for biotech and pharma companies to survive, let alone prosper. Alpha Biologics has been established to address this issue by providing our clients with the opportunity to take their biologic drugs through the early clinical trial phases at a cost is easily justified. This avoids the abandonment of potential blockbuster drug programmes based simply on cost before it has been possible to demonstrate safety and early efficacy.
Our goal is to deliver innovations on time for clinical trials at a price that is affordable, thereby enabling our clients to maintain strong development pipelines and realise maximum value from their investments in research and development.
Mammalian Cell Culture
Fed Batch
The Alpha Biologics facility will operate stirred tank vessels, ranging in volume from 10L to 500L, and will operate as a multi-product facility in line with the FDA design review. The range of available vessels will enable Alpha to produce our client's drugs at the most efficient scale, thereby ensuring on-time delivery at the best possible price.
cell culture media
Cell culture media are specially formulated solutions that provide the essential nutrients, growth factors, and energy sources required to support the survival and proliferation of cells in vitro. They serve as the foundation of cell-based research, enabling scientists to mimic the natural cellular environment and study biological processes under controlled conditions. Depending on the application, media can be customized with specific components such as amino acids, vitamins, hormones, or serum to optimize cell growth, differentiation, and productivity. From fundamental research in cell biology to large-scale biomanufacturing of vaccines, antibodies, and therapeutic proteins, cell culture media are indispensable tools that drive innovation in both basic science and applied biotechnology.
Perfusion
Maximum flexibility and increased production capacity will be achieved by combining stirred tank with tried and tested perfusion technology that will realise a minimum of a 20-fold increase in productivity per vessel. This will ensure that Alpha Biologics is able to produce as much mammalian cell secreted protein as needed for any phase of pre-clinical and clinical trials. We will also have the capacity and capability to produce early market material for some products.
Good Manufacturing Practice
The Alpha Biologics facility has been designed to be compliant with both European and US FDA cGMP guidelines. The Alpha staff have many years of experience in designing and operating mammalian cell contract manufacturing and in-house manufacturing facilities in compliance with cGMP's. They are experienced in working with the regulatory authorities in both Europe and the United States to ensure successful facility audits.
The Alpha facility design underwent FDA review prior to construction of the facility to ensure cGMP compliance, with the final design incorporating any FDA recommendations.
Upstream Process Development
Alpha Biologics has an Process Development facility incorporated into the entire facility. It is equipped with identical technologies to the cGMP production suites to ensure seamless transition to the production suites once a process is ready for cGMP manufacture. Upstream Process Development will operate with a dedicated team of experienced staff, who will nevertheless be able to work closely with the cGMP staff to ensure there is a clear understanding of the process requirements and specifications and a smooth transition of the process at the appropriate time. Alpha will be able to work with our clients to either adapt a well developed manufacturing process or develop a new process from early research phase.
Cell Banking
Alpha Biologics will be able to develop stable cell lines and Master and Manufacturing Working Cell Banks prior to cGMP manufacture. We will also provide cell line storage services to ensure that subsequent manufacture of our clients' drugs can occur with minimal delays. In addition, our team applies rigorous testing and characterization of each cell line, including stability, productivity, and genetic integrity assessments, to guarantee long-term reliability.
All cell banking activities are performed under strict regulatory compliance and quality assurance frameworks, ensuring alignment with international guidelines such as ICH and FDA/EMA standards. By integrating development, storage, and quality control, Alpha Biologics provides a seamless transition from research to clinical and commercial manufacturing. This comprehensive support allows our clients to focus on advancing their therapies with confidence, knowing that their critical cell line assets are safeguarded and ready for scale-up at any stage of production.
Hybridoma/CHO Cell Lines
Alpha Biologics will work with most mammalian cell line types to produce monoclonal antibodies and recombinant proteins for clinical trials. The proteins will be produced in compliance with cGMP guidelines to enable our clients to conduct their clinical trials in the most appropriate geographical locations.
Downstream Process Development
As with Upstream Process Development, Alpha Biologics has a Downstream Process Development facility incorporated into the entire facility. It is equipped with identical technologies to the cGMP purification suites to ensure seamless transition to the purification suite(s) once a process is ready for cGMP manufacture. Downstream Process Development will operate with a dedicated team of experienced staff, who will nevertheless be able to work closely with the cGMP staff to ensure there is a clear understanding of the process requirements and specifications and a smooth transition of the process at the appropriate time. Alpha will be able to work with our clients to either adapt a well developed manufacturing process or develop a new process from early research phase.
Monoclonal Antibodies
The Alpha Biologics team will develop processes designed for optimum yields of MAbs while ensuring maximum purity and safety profiles for use in clinical trials.
Recombinant Proteins
The Alpha Biologics team will develop processes designed for optimum yields of rProteins while ensuring maximum purity and safety profiles for use in clinical trials.
What are Recombinant Proteins?
Recombinant proteins are proteins made by inserting a specific gene into a host cell, such as bacteria, yeast, or mammalian cells. These cells then produce the protein using their own machinery.
Main Advantages
Recombinant proteins are produced in high purity, consistent quality, and large amounts. This makes them safer, more reliable, and easier to use than proteins taken directly from natural sources.