Next-Generation Facilities for Monoclonal Antibody Production - Pharmaceutical Technology

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Next-Generation Facilities for Monoclonal Antibody Production
Dramatic increases in yields from cell lines and the increasing popularity of single-use technologies will change the way we look at future bioprocessing facilities and process designs.


Pharmaceutical Technology
Volume 33, Issue 7, pp. 68-73

A greener facility. What will be the environmental impact of the next-generation facilities? The idea of disposing plastic bags appears as intuitively wasteful but must be compared with traditional technology that requires cleaning and sterilization between each batch.

A recent study concluded that single-use technology is approximately 50% less energy intensive than stainless steel because the consumption and heating of large volumes of water to clean and sterilize is more energy demanding than producing and inactivating plastic bags that also can be incinerated for energy recovery (9). Even though waste disposal as landfill leaves little CO2-footprint, it does not appear as a sustainable solution in the long term. Add to these considerations the markedly increased yields and it becomes evident that a next-generation facility will have a smaller CO2-footprint per kilogram of mAb produced compared with a traditional facility. For all facilities, it must be remembered that any single-use waste flow is only part of the solid waste flow. Mauter described in very good detail how common assumptions may be challenged through a life-cycle analysis of these technologies (10).

Conclusion and future perspectives

Although there are still some hurdles, trends will combine to bring next-generation monoclonal facilities on-line during the next two to five years. New cell lines and process technologies will result in 1000 kg mAb/year capacity in 1000-L scale becoming available in smaller, more flexible, and more cost- effective facilities with investment cost and variable cost massively improved compared with current facilities with similar output.

But new cell lines and new process technologies may also seriously extend the capability of existing facilities. Provided that fundamental requirements are observed in the facility design, workflow and data-handling systems facilities can be retrofitted with next-generation technology. Development laboratories may then be able to cover pilot-plant scale, and pilot plants or sections of production plants may suddenly acquire the capacity for launch or production capacity. Thus, in the near future and with the current economic climate, the most common next-generation mAb facility may actually be the upgraded facility.

Niels Guldager is a senior consultant for bioprocess and technology at NNE Pharmaplan A/S, Copenhagen, Denmark, tel. +45 3079 7246, fax +45 4444 3777,

References

1. Pharmaceutical Research and Manufacturers of America, "Biotechnology Research Continues to Bolster Arsenal Against Disease with 633 Medicines in Development," http://phrma.org/medicines_in_development_for_biotechnology/, accessed June 1, 2009.

2. T. S. Charlebois, "Next Generation Commercial Processes," presented at IBC's 22nd International Antibody Development & Production Conference, Carlsbad, CA, 2009.

3. P. Taylor, "New PhRMA Chief Says Healthcare System is 'Broken," http://in-pharmatechnologist.com/On-your-radar/Globalisation/New-PhRMA-chief-says-healthcare-system-is-broken/ accessed May 22, 2009.

4. C. Schott, "Proactive Debottlenecking: Planning Ahead for the Downstream Bottleneck," BioProcess Int. 6 (9), 18–23 (2008).

5. T. Ryll, "How Do We Get to 30g/L using Fed-Batch Technology? What are the Limitations?" presented at IBC's 22nd International Antibody Development & Production Conference, Carlsbad, CA, 2009.

6. G.M. Ziljstra, "Monoclonal Antibody Titers of 25 g/L and Beyond with a Human Cell Line in the XDT Process," presented at ACHEMA 2009, Frankfurt, Germany (2009).

7. U. Gottschalk, "Bioseparation in Antibody Manufacturing: The Good, The Bad, and The Ugly," Biotechnol. Prog. 24 (3), 496–453, (2008).

8. G. Jagschies, "Where is Biopharmaceutical Manufacturing Heading?" Biopharm Int. 23 (10), 16–22 (2009).

9. B. Rawlings and H. Pora, "Environmental Impact of Single Use and Reusable Bioprocess systems," BioProcess Int. 7 (2), 18–26 (2009).

10. M. Mauter, "Environmental Life-Cycle Assessment of Disposable Bioreactors," BioProcess Int. 8 (4), 18–28 (2009).


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