OXFORD BIOMEDICA

OXFORD BIOMEDICA

About the company

Oxford Biomedica (also known as OXB) is a quality and innovation-led cell and gene therapy CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world.

One of the pioneers in cell and gene therapy, OXB has more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies. OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV), adenoviral vectors and other viral vector types. OXB’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.

OXB is headquartered in Oxford, UK. It has 14 GMP production suites with bioprocessing and manufacturing facilities across Oxfordshire, UK, Lyon and Strasbourg, France, and near Boston, US. OXB offers

About the solution

OXB has unique experience in developing and manufacturing lentiviral vector, AAV and adenoviral vector with expert capabilities from plasmid design to commercial GMP manufacturing and fill finish. OXB was the first commercial supplier of LV for a CAR-T product in the world. OXB has taken more than 30 customers’ projects to IND.

OXB offers a vast number of unique technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the Tetravecta system), dual plasmid system for AAV production, suspension and perfusion process using process enhancers and stable producer and packaging cell lines.

OXB also offers adenovirus and MVA vaccine production services and has process development capabilities and analytical methods accepted by regulatory authorities enabling the delivery of projects from pre clinical to commercial stages.

OXB has unique in-house analytical development capabilities to characterise vector and achieve rapid batch release, included automated assays and advanced mass spectroscopy.

Additionally, OXB offers regulatory authoring and reviewing support for IND/IPMD, BLA/MAA submissions.

Key information

– Therapeutic areas: Cell and gene therapy, Vaccines

– Based in: Strasbourg & Lyon (FRANCE), Massachussetts (US)

– Employees: 500+

– Created in: 1996

HORIANA

HORIANA

About the company

HORIANA is a premier consulting company dedicated to epidemiology and biostatistics, specializing in designing and conducting Healthcare Real-World Studies.

Established by a team of seasoned experts, each with over 15 years of experience in Life Sciences, Horiana is at the forefront of providing comprehensive support to its clients. With a dedicated team of more than 25 experts, Horiana is well-positioned to assist clients at every phase of their projects. Their clients span both private and public/academic healthcare professionals.

At HORIANA, they are committed to excellence and quality, ensuring the success of their clients’ projects.

About the solution

Their main solutions are:

– Expertise and Consulting: Specialized guidance in epidemiology, pharmacoepidemiology, and biostatistics/data science.
– Clinical and Observational Studies (on primary and secondary)
– Enriched Studies: Integration of data from diverse sources through multisource studies and linked studies.
– Evidence Synthesis: Conducting External Comparators such as Network Meta-Analysis (NMA) and Matching-Adjusted Indirect Comparison (MAIC).
– Synthetic Control Groups: Implementation of Synthetic Control Groups and External Control Arms.
– Training Programs: Certified QUALIOPI training center in Statistics & Epidemiology
– IDMC, DSMB and Strategic consulting

Key information

–  Therapeutic areas: Biostatistics, Epidemiology & Data Science provider

–  Based in: Bordeaux, Grenoble (FRANCE) San Francisco (US)

–  Employees: 11 – 50

– Created in: 2021