Preclinical Production

You have a vial of mammalian cells with the gene of your target drug and you are eager to produce pre-clinical material for toxicology studies.  Look no further.  At Laureate, we have built a brand new pilot plant facility to accelerate the production of your pre-clinical material.  The plant is now available for engineering runs and pre-clinical production.

We have designed the pilot plant to accommodate process development, production and purification of preclinical proteins. The pilot plant is isolated from our main manufacturing area and features two separate production suites and two expanded purification suites to support pre-clinical production of protein based products from mammalian cells. The suites mimic our already existing cGMP production facility and equipment to facilitate a direct, seamless scale-up from development to cGMP production. The pilot plant has stainless steel, stirred-tank bioreactors and disposable, single-use bioreactors – the same technologies we use in our larger scale cGMP-manufacturing facility. The purification suites feature the same process chromatography and filtration technologies we use in the cGMP facility. With the new pilot plant in operation, we can accelerate manufacturing of pre-clinical material and save several months of critical product development time.

Pilot Plant equipment:

Stirred-Tank

• 1 x 300L (200L Vw)
• 1 x 75L (~50L Vw)
• 2 x 7L (5L Vw)
• 2 x 3L (2L Vw)

WAVE Bioreactor®

• 1 x System 200
• 2 x System 20/50
• 1 x System 2/10

Purification

• 2 x 3L/min chromatography skid ÄKTA™ Process GE Healthcare
• 200L CUNO filtration skid
• Cross-flow filtration skid 30L/min – Uniflux™ GE Healthcare

Reasons why you should use our pilot plant:

• You don’t have to wait for full cell line qualification. We need only minimal qualification (sterility and mycoplasma testing) for cells entering the pilot plant
• We can run pilot and engineering runs in the shortest time possible
• We’ve designed the pilot plant suites to mimic our existing cGMP production facility and equipment so that we can seamlessly transfer the product/project from pre clinical development to cGMP production
• You save 2-3 months of critical product development time

Please give us a call to discuss your
preclinical production needs

201 College Road East
Princeton, New Jersey 08540
Contract Services: 1.609.919.3400
Main Office: 1.609.919.3300
Fax: 1.609.520.3963
Email: [email protected]
www.lbios.com