ProFactor Pharma
ProFactor Pharma Ltd (PFP) is a UK biotech company dedicated to transforming treatment availability for Haemophilia A patients by developing low-cost, high-yield recombinant Factor VIII (FVIII) products. The company focuses on manufacturing affordable, innovative therapies to serve the large, undertreated patient population worldwide, especially in emerging markets. PFP's mission is to provide accessible treatment options, leveraging proprietary technology and strategic partnerships, to address the significant unmet needs in haemophilia care globally.
Industries
Nr. of Employees
small (1-50)
ProFactor Pharma
Products
Standard half-life recombinant Factor VIII (rhFVIII)
A standard half-life recombinant Factor VIII therapeutic candidate produced from a high-yield mammalian cell line and optimised bioprocess, intended for replacement therapy in Haemophilia A.
Enhanced half-life recombinant Factor VIII (engineered rhFVIII)
A sequence-engineered recombinant Factor VIII candidate with DNA modifications intended to increase circulating half-life; currently in preclinical proof-of-concept testing.
Standard half-life recombinant Factor VIII (rhFVIII)
A standard half-life recombinant Factor VIII therapeutic candidate produced from a high-yield mammalian cell line and optimised bioprocess, intended for replacement therapy in Haemophilia A.
Enhanced half-life recombinant Factor VIII (engineered rhFVIII)
A sequence-engineered recombinant Factor VIII candidate with DNA modifications intended to increase circulating half-life; currently in preclinical proof-of-concept testing.
Services
Bioprocess development and optimisation
Upstream and downstream process development for recombinant protein production, including single-use bioprocess implementation and scale-up support.
Cell line development and GMP cell banking
Development of high-expressing stable mammalian cell lines and generation of GMP-compliant Master and Working Cell Banks.
Preclinical development and toxicology services
Execution of preclinical proof-of-concept studies and toxicology studies to support regulatory submissions for first-in-human trials.
Analytical characterisation and comparability testing
Structural and functional characterisation services to demonstrate comparability with marketed reference products.
CMC and manufacturing scale-up via CMO partnerships
Transfer of developed processes to contract manufacturing organisations for scale manufacturing runs and supply of clinical/commercial material.
Regulatory and IP strategy support
Preparation of IP filings and regulatory engagement strategy to support clinical entry and commercialisation.
Bioprocess development and optimisation
Upstream and downstream process development for recombinant protein production, including single-use bioprocess implementation and scale-up support.
Cell line development and GMP cell banking
Development of high-expressing stable mammalian cell lines and generation of GMP-compliant Master and Working Cell Banks.
Preclinical development and toxicology services
Execution of preclinical proof-of-concept studies and toxicology studies to support regulatory submissions for first-in-human trials.
Analytical characterisation and comparability testing
Structural and functional characterisation services to demonstrate comparability with marketed reference products.
CMC and manufacturing scale-up via CMO partnerships
Transfer of developed processes to contract manufacturing organisations for scale manufacturing runs and supply of clinical/commercial material.
Regulatory and IP strategy support
Preparation of IP filings and regulatory engagement strategy to support clinical entry and commercialisation.
Expertise Areas
- Biologics manufacturing and bioprocessing (CMC)
- Mammalian cell-line development
- Protein engineering and half-life extension
- Upstream fermentation and single-use bioprocessing
Key Technologies
- CHO-based mammalian expression
- Codon optimisation / sequence engineering
- Single-use disposable bioreactors
- Upstream fermentation optimisation