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Benefits of Process Development PDF Print E-mail


Avid Bioservices® is committed to offering process optimization as a valuable service to our clients. Avid will review the current expression data and then determine what is the value of process optimization to the commercialization of your product.


At Avid Bioservices, we firmly believe in the benefits of process optimization because it represents a critical junction in the road to successful commercialization of your product. This is where we can assist you on your path to commercialization. Processes that have not been sufficiently optimized may even make the development of a promising new treatment cost prohibitive. At Avid Bioservices, we understand the cost effective benefits of optimizing at each of the four stages in the development and manufacture of monoclonal antibodies and recombinant proteins. In the first stage, there is the choice of cell types and expression systems. The second stage investigates the nutritional requirements for optimum growth and expression. In the third stage, the bioreactor conditions and control modules can be optimized, and in the fourth stage, the harvest and purification process is examined.

The following table is an example which demonstrates the value of process optimization where the final requirement is for 0.5 kg of protein. The process expressing 10 mg/L in a batch process requires 167 runs in our 300L bioreactor. Just optimizing to 50 mg/L reduces the number of runs to 34, a five-fold decrease. Levels of improvement can vary greatly in their cost benefits. Knowledgeable staff at Avid Bioservices can discuss the merits of process optimization for your application.




   

Protein Production Level (mg/L)

300L Production (g)

300L Production (kg)

0.5 kg/year
Number of Runs

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10

3

0.003

167

50

15

0.015

34

100

30

0.03

17

150

45

0.045

12

200

60

0.06

9

250

75

0.075

7

300

90

0.09

6

350

105

0.105

5

400

120

0.12

4

450

135

0.135

4

500

150

0.15

3