GMP Cell & Gene Therapy  Manufacturing

We can provide a full GMP manufacturing service for sterile formulations and advanced therapies, including cell and gene therapies. Our team provide quality and compliance services including QP release of products.

Cell and Gene Therapies & Small Volume Aseptic Products

Contract Development and Manufacturing Organisation (CDMO)

 

HiTech Health can provide an end-to-end development and manufacturing expertise for cell and gene therapies as well as small volume aseptic products. We operate our development laboratories to Good laboratory Practice (GLP) standards and under the same quality management system (QMS) which ensures a cost effective and streamlined partnership for the manufacture of GMP product for your clinical trials.

HiTech Health’s range of services include:

  • GMP manufacturing for advanced medicines including cell and gene therapies.
  • GMP manufacturing for sterile products (clinical scale volumes) including vial and bag filling.
  • Full service from analytical and process development through manufacturing, Quality Control (QC) testing, packaging, batch release and distribution.
  • Sourcing and supply of starting materials.
  • Ambient, cold chain and cryogenic storage solutions.

 

Cell and Gene Therapy Manufacturing

HiTech Health are delighted to have an article entitled 'Cell and Gene Therapy Manufacturing Considerations for Early Stage Companies' published in distinguished publications, cellandgene.com and outsourcedpharma.com. The article should be of benefit to companies who...

2024 ATMP Review

Over the past decade, the regenerative medicine landscape has undergone an extraordinary evolution with the continuous growth of Advanced Therapeutic Medicinal Products (ATMPs). ATMPs are medicines for human use that are based on genes, tissues or cells. They treat...

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