TECHNOLOGIES COVER
A WIDE SPECTRUM
• Synthesis of complex proteins and peptides including macromolecules such as recombinant human insulin or monoclonal antibodiesrecombinante ou les anticorps monoclonaux
• Genomics and pharmacogenomics as well as the use of gene probes
• DNA and RNA sequencing and synthesis
• DNA/RNA amplification (PCR)
• Gene expression and antisense technologies with applications to genetic engineering
Discover our know-how in Sterile products domain
THE SCOPE OF BIOTECHNOLOGY
IS EVOLVING CONTINUOUSLY
The applications of biotechnologies cover various fields and always evolving. Agriculture, biological engineering applied to chemistry (manufacturing products such as biofuels, biogas by transforming vegetal raw materials into bioethanol thanks to micro-organisms). Treating and eliminating waste to reduce pollution, new pharmaceutical products manufactured using marine organisms are other developments in biotechnology.
In the medical field, biotechnologies provide innovative tools in three main areas:
Understanding of the biochemical mechanisms involved in a pathology
Support to diagnosis or identification of populations genetic characteristics, such as in the context of cell typing (HLA)
Manufacturing of molecules or therapeutic/prophylactic treatment for prevention or cure of diseases
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BIOTECHNOLOGy innovations
APPLIED TO LIFE SCIENCE
Many companies made the shift to biotechnology in the late 90’. Today, biotechnology is pivotal for the development of new products in Life Science. Innovations are expected in bioinformatics and nanobiotechnology, enabling the manufacture of nano or micro-compounds, or complex biomolecules.
The manufacturing of biological products has highlighted five key concerns over the years:
• Bio-production capacity is still limited across the world
• The manufacturing cost of biologics is high compared to small molecules, raising the concern of process performance and yields to produce biomolecules required in relatively large quantities such as monoclonal antibodies
• The control of complex manufacturing processes which, in some cases, must be sterile or axenic
• The quality culture which requires a real partnership between the functions for the design and control of the processes all over the product Life Cycle, from development to commercial supply
• The complexity of the preclinical and clinical development of these products, with a process to be often finally designed from phase 3 clinical trials
Biotechnology, a fundamental ally for the development of health products
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Humanim gathers Technical, Quality, Operational and Strategy experts experienced in the Life Science industry.
They work as a cross functional team in partnership with your teams, to help you transform your innovation into a concrete success to develop, manufacture and distribute your diagnostic, therapeutic or prophylactic products from biotechnologies.
Discover our
"Biotech Scale-Up" offer
HUMANIM TEAM SUPPORTS YOUR TRANSFORMATIONS BEYOND REQUIREMENTS AND STANDARDS
The manufacture of biomolecules is governed by the regulations applicable to biopharmaceutical products such as Good Manufacturing Practices.
The health authorities require biomolecules manufacturers to comply with GMP rules with specificities for this type of product. In particular, the regulatory environment focuses on risk and science base decisions. This is particularly true for production of complex biologics such as cell therapy products. The entire company must then adapt or evolve its processes and behaviors to meet these expectations.
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Trust Humanim's experts to support you in your transformations and towards regulatory compliance
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Humanim's teams can help you meet these challenges thanks to their knowledge of historical and specific regulations. They also offer you their experience and expertise in mastering the control strategy for these products (Quality by Design). Our experts are also well-versed in the implementation of quality culture within teams that are constantly evolving in the pharmaceutical world.
THE STRENGTH OF THE COLLECTIVE TO MEET THE REQUIREMENTS
The Life Science industry have created associations to provide common answers and to share best practices. These includes A3P, a french association with European influence, or American associations such as the Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE). BioPhorum also has discussion groups in the fields of bio-production and development of biological products. Finally, the International Conference on Harmonization (ICH) issues regularly guiding documents specific to biotechnology products, such as the ICH Q5.
There are opportunities to see these associations working together and provide a common response to new regulations, as is currently the case for the revision of Annex 1 of Eudralex Vol 4.
Discover the "People and culture" offer to imagine a shared goal