A NEW WAY TO MANUFACTURE BIOPHARMACEUTICALS

When it’s time to move from preclinical to clinical-phase product testing, many biopharmaceutical companies face a difficult decision: whether to build or buy a biomanufacturing facility for in-house production or outsource the work. Accinov proposes a new solution that straddles the line between those concepts. The biomanufacturing center supports client companies toward clinical development in an innovative way.

Accinov offers a prequalified GMP environment that includes integrated pharmaceutical support services and pharmaceutical responsibilities. This approach allows drug-sponsor companies to run their own processes and to focus on their own core manufacturing activities in a flexible facility.

Accinov can meet different needs according to a company’s maturity, type of products, or development stage:

  • Small biotech companies
  • Large companies
  • Contract manufacturers

Facts & Figures:

  • 3 independent biomanufacturing units of 200 m2 with dedicated storage facilities (80 m2) & QC laboratories (20 to 70 m2)
  • Biosafety level 2, GMO authorized
  • Small scale production capacity (20 to 500 L)
  • Standard equipment provided : BSC, LFH, solution preparation, freezers/cold room, centrifuges, peristaltic pumps, incubators, spectrophotometers …
  • Leasing solution for specific process equipment
  • GMP staff recruitment & GMP staff training services
  • Less than 3 months between the MSA signature & the start of a GMP production
  • Possibility to support the whole pharmaceutical responsibility of the project (out-sourced quality control tests & production steps (i.e. Fill & Finish operations) to release the drug product
  • Storage of the manufactured products & stability studies

HOW IT WORKS?

Accinov’s business model relies on a new 70,000-ft² (6,500-m²) building designed to meet the high-end requirements of clinical material development and manufacturing. Access to the infrastructure is provided as part of a broader service offering that includes GMP facility management and pharmaceutical support and expertise. Qualified persons and quality-assurance services ensure compliance of activities performed by clients with GMP regulations and the Accinov quality management system.

Our quality and pharmaceutical services are responsible for releasing raw materials and drug batches as well as qualifying suppliers and auditing third parties. That allows client companies to focus on their own core bioprocess and analytical activities.

Accinov staff members are also dedicated to site management, including technical maintenance and coordination of services such as site security, cleaning, and deliveries. Hosted companies dedicate their own staff to strategic activities without the constraints of fully operating a GMP site on their own.

The facility design and the site management ensure confidential control of intellectual property (IP) and know-how without risk of cross-contamination.

Accinov’s solution for GMP manufacturing:

Scenarios Advantages
Small business or start-up company
When working with innovative expression systems or products
Increase know-how and product knowledge
When internal manufacturing is a strategic choice Start manufacturing in a supportive environment
Large pharmaceutical company
When no free GMP pilot-plant is availableAccess additional capacities for clinical projects
When small commercial batches are neededPrevent delays of early stage projects
When new technology evaluation is infeasible internallyEnable collaboration with other companies
Contract manufacturing organization
When reaching capacity saturation Access additional capacities
When current product authorization hinders new projects Produce new/different types of products
Work with different technologies or process set-ups