CellVec prides itself on a superior lentiviral vector technology that consistently produces improved yields and high process consistency. The heart of our advanced lentiviral vector platform comprises of:
- Our GMP-compatible molecular expression helper plasmids, which have been developed and validated in-house for lentiviral vector manufacture
- Our third generation, self-inactivating lentiviral vector designed in-house for efficient transgene expression
- HEK 293T Master Cell Bank, adapted and conditioned for enhanced recovery and propagation
- Scalable LV manufacturing process ranging from 1.3 litre to 15 litres
CellVec is constantly innovating to match the ever-evolving needs of our clients and the cell and gene therapy industry, where cost-effective large-scale manufacturing and compliance to regulatory standards are major challenges.
From optimising our lentiviral helper sequences and developing novel stable producer cell lines, to defining our chemical formulations and purification processes, our development efforts are focused on optimising every part of our manufacturing process in order to produce high quality lentiviral vectors with novel pseudotypes that boast enhanced titres, yields, purity, stability and cell-type specific transduction efficiencies.
CellVec manufactures clinical grade retro and lentiviral vectors under GMP as Active Pharmaceutical Ingredients (API) for human gene therapy. Our manufacturing process utilizes single-use, closed system technologies and incorporates validated decontamination, sterilisation and aseptic manufacturing processes from Upstream (USP) to Downstream (DSP) and Fill Finish in cryobags or vials. We are able to produce pilot and engineering batches ranging from 1 to 5 litres and GMP batch sizes ranging from 15 to 48 litres.
Supported by a purpose-built warehouse, we have a robust raw material management and quality control and release system in place. Our warehouse also prides itself on its state-of-the-art deep freezer, Cryogenic storage facility and a validated and controlled coldroom.
Regulatory and Quality Assurance
CellVec boasts a GMP-certified pharmaceutical quality system (PQS) and facility, awarded by the Health Sciences Authority of Singapore (HSA) under current PIC/S guidance annexes for medicinal products. They are designed in alignment to US FDA, EU GMP & TGA (Australia) regulations and industry expectations.
We have continuous access to experienced regulatory support and advice for Cell and Gene Therapy applications, and pride ourselves on company-wide awareness of the latest requirements and expectations on Good Documentation Practice and Data Integrity.