Process scale-up capabilities.
Porton Biopharma (PBL) is a UK-based company experienced in developing, manufacturing, and bringing life-saving biopharmaceutical therapeutics and vaccines to market.
The company is an expert at taking concepts from the research laboratory to production, progressing through various stages of scale-up and process development. The result is clinical-grade material, which is suitable for clinical trial. This includes both native and recombinant therapeutic proteins.
Manufacturing and product development
Porton Biopharma’s development group offers a range of product-focused services, including development and scale-up, product characterisation, analytical development and qualification, and process troubleshooting, as well as pre and good manufacturing practice (GMP) manufacturing capacity.
Its state-of-the-art current good manufacturing process (cGMP) manufacturing facilities are licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA), Food and Drug Administration (FDA), and Pharmaceuticals and Medical Devices Agency (PMDA).
The facilities are used for its biopharmaceutical products, which include the UK’s licensed anthrax vaccine, and therapeutic enzyme Erwinase®, which is used to treat acute lymphoblastic leukaemia (ALL) and is licensed in 20 territories worldwide.
Specialist expertise focused on delivery
By building on the knowledge and experience gained from successfully manufacturing its own products, the company is able to offer access to its facilities and expertise to clients for the production of a wide range of clinical materials.
These including unique containment level 3 capabilities geared to the bespoke manufacture of low-volume, high potency and toxicity bacterial products.
PBL also offers access to its specialist laboratories and bespoke services for translational development to help new biopharmaceutical products progress from gene to GMP.
Capabilities range from <1l bench-top fermenters to the recently completed fermentation suite, which features four 15l vessels and a 50l vessel to enable parallel development and scale-up experiments with cell harvesting by batch or continuous centrifugation, or tangential flow filtration.
Product purification expertise includes in-house capabilities in preparative chromatography, protein crystallisation and tangenital flow filtration (TFF) from laboratory-scale to 1,000l.
Process redevelopment and qualification
Experience gained from the continuous improvement of its processes enables PBL to offer a complete range of services, including complete process redesign, introduction of disposable technology, process modification and improved analytical methods. These activities are underpinned by the expert knowledge of its regulatory and validation teams.
Analytical development and qualification
The company’s development group designs and adapts a wide range of analytical techniques to demonstrate process reproducibility and product quality. Method qualification ensures that such techniques are fit for their intended purpose.
PBL works with both start-up biotech and large pharmaceutical organisations on a worldwide basis. It has active collaborations with academic departments engaged in bioprocessing developments.
Even long-established manufacturing processes may suffer from unexpected problems. PBL’s staff are adept at determining the root cause of process failures outside of the manufacturing environment. This vigilance reduces costs and manufacturing down-time, and also allows them to provide advice on appropriate remedial action.
About Porton Biopharma
Porton Biopharma’s strategy as a new company with a distinguished heritage is to grow its existing business and product pipeline, whilst also building relationships across the industry.
It was commercialised out of Public Health England on 1 April 2015, which enabled it to be better placed to grow the business of developing and manufacturing life-saving products. The company is built upon decades of biopharmaceutical experience, including the successful licensure of many therapies that save thousands of lives every year and generate revenues from world-wide sales.
PBL offers expertise in developmental production of biologicals, including product characterisation, process and analytical validation, and scalability for market. Allied with its experience of regulatory compliance gained from the licensure of its own products, this puts it in an ideal position to offer expertise and enable others to successfully bring their products to market.
In order to find out how Porton Biopharma can help you move your research from the bench to the clinic, please contact them via the enquiry box.
China's largest animal vaccine company Jinyu Bio-technology unveiled plans to establish its first US-based vaccine research lab and office facility in May 2017.
Porton Biopharma Limited (“PBL”), the UK biopharmaceutical research, development and manufacturing company, announces that it has signed an exclusive, worldwide licensing agreement with Clinigen Group plc (“Clinigen”) for the distribution of Erwinase®/ Erwinaze® (“Erwinase”), the Company’s life-saving treatment for acute lymphoblastic leukaemia, a cancer of the blood predominantly affecting children.
Porton Biopharma Ltd (PBL) has announced that it has signed a modification to its contract (HHSN272201600045C) with the US National Institute of Health’s National Institute of Allergy and Infectious Diseases (NIAID) to advance a next-generation intra-nasal anthrax vaccine into the clinical-trial phase.
PBL will be attending the Innovation in Manufacturing Through Collaboration event in Darlington, UK, on Wednesday 27 March.
In advance of the National Apprenticeship Week, Porton Biopharma (PBL) is excited to announce that it has hired its first apprentice, Will Tucker.
Porton Biopharma has announced that it will be attending and presenting at a number of international conferences in September, October and November.
In a ribbon-cutting ceremony, John Glen MP for Salisbury and South Wiltshire has officially opened Porton Biopharma’s (PBL) new fermentation facility, which will be used to manufacture the company’s leukaemia drug Erwinase®.
Three leading British biotechnology businesses have obtained grant funding from Innovate UK to investigate the manufacture of a new class of medicines, targeting a range of clinical conditions through interaction with the human microbiome.
UK-based Porton Biopharma Limited (PBL) is pleased to announce it has officially opened and named its new multi-million pound pharmaceutical laboratories.
Porton Biopharma Ltd (PBL) has announced that it has signed a modification to its contract with the US National Institute of Health's National Institute of Allergy and Infectious Diseases (NIAID) to advance a next generation intra-nasal anthrax vaccine. The contract modification is worth US$5.6 million.
In a ribbon cutting ceremony Dr Peter Hughes, Director of Quality at Porton Biopharma (PBL) has opened a brand new suite of office accommodation to bring together members of quality assurance (QA) and other departments into one integrated set of buildings.
In a ceremony led by Baroness Scott of Bybrook OBE, Porton Biopharma (PBL) has begun construction of a new pharmaceutical development facility, which will provide state-of-the-art facilities for its teams of scientists.
In a ceremony led by Salisbury's MP John Glen, Porton Biopharma has initiated construction of a new multi-million facility.
Chairman of the Porton Biopharma (PBL) Martin Hindle opened an extension of its facility for the storage of raw materials.
Ohara Pharmaceutical have submitted a new drug application for PBL's Erwinase® in Japan.
A new mutli-million pharmaceutical manufacturing facility has been opened at Porton Biopharma (PBL).
The transfer of Public Health England's (PHE) clinical drug development and production capability into a standalone, state-owned biopharmaceutical limited company has been approved by the Secretary of State for Health.
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