A Case Study: Fast track project Technology Transfer and commercial manufacturing at Rechon.
Rechon Life Science ABs Project Manager Maria Wingren tells us about a fast track project from Technology Transfer to Commercial Manufacturing.
“In mid November 2010 an agreement between Rechon Life Science AB and Bioglan AB regarding contract manufacturing of a medical device nasal spray in the allergy field was signed. Bioglans goal was to have the product BLOX4™Allergy introduced on the market in time for the allergy season in Scandinavia.
In general the technology transfer phase for a commercial project is about 6 months, however for this project the technology transfer and manufacturing had to be completed in less than 4 months in order to meet the set release date and have the product at the Pharmacies on March 18th 2011. A project group, with members from production, QA, QC of both Rechon and Bioglan, was formed and the challenging and exciting work was started.
The project included:
· Technology Transfer of the manufacturing process and process design
· Set up of microbiological methods for all raw materials and finished product
· Set up of chemical methods for all raw materials and finished product
· Manufacturing, including compounding, filling, testing, packaging and release of one full scale commercial batch, 400 kg, ~ 40 000 spray vials
· Manufacturing of one small scale placebo batch.
Key points/critical activities:
Purchase, installation and qualification of new size parts for a filling line normally take about 3-6 months including time for test runs and qualification. A nasal spray pump with the same outer dimension as an existing product was chosen and present size parts could be used.
The delivery of nasal spray pumps and excipients in time was critical in order to reach our dead line. Hence constant follow up and discussions with suppliers were crucial and resulted in that all material was delivered according to plan.
All documentation, batch records, change control, risk assessment etc were prepared in advance to be able to start the manufacturing as soon as all material were tested and released.
In mid February, less than 2 weeks after deliver of the last material, the compounding was started, filling was performed and filled spray vials were sent for testing and secondary packaging.
In mid March less than 4 months after signing of the agreement, the commercial product was released and shipped. The project was successfully finalised in due time much thanks to the good collaboration and knowledgeable personnel at both Rechon and Bioglan.
This is yet another acknowledgement that our proven Project Management Process works even in projects with demanding time lines.
Information regarding Rechon’s Project Management Process
Rechon’s project management approach is based on the principle that every project is unique, with clear objectives, a defined schedule and full cost allocation. Projects are managed via a structured process that helps to accelerate completion and reduce costs while enhancing the end product and fulfilling project objectives. The Project Steering Committee (PSC) is responsible for all strategic project decisions, including stop-or-go decisions. The PSC evaluates project ideas, reviews progress, identifies problem areas and makes resource assessments throughout the project process.
Information regarding BLOX4™Allergy
BLOX4™Allergy efficiently blocks the allergy causing agents/allergens from reaching the nasal mucosa and releasing the histamine cascade. BLOX4™Allergy has clinically demonstrated protection both towards pollen and dust mite allergy. More information regarding the product can be found www.blox4allergy.com