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Pharmaceutical Processing Announces 2014 Facility Excellence Award Winners

Mon, 03/03/2014 - 12:15pm
Jeff Reinke; @JeffReinkeABM

New development technologies, expanded contract manufacturing and service capabilities, as well as innovative equipment investment strategies highlight leading practices from the best in pharmaceutical processing.Facility Excellence Award

The Caliber Biotherapeutics manufacturing facility in Bryan, Texas offers an interesting look at the development and integration of Plant Made Pharmaceuticals. The Caliber facility provides 128,000 square feet for growing up to 2.2 million Nicotiana benthamiana plants, and came into being as the result of a Technology Investment Agreement between the Defense Advanced Research Projects Agency (DARPA) and Caliber’s parent company, G-Con.  

The agreement was part of Project Blue Angel, an H1N1 acceleration project designed to show that Plant Made Pharmaceuticals (PMP) can be scaled-up to deliver biotherapeutic proteins at a lower cost. The facility began initial production in late 2011, with the goals of proving that a plant-based system offers the advantages (compared to mammalian cell systems) of higher throughput development and screening of monoclonals and easier manipulation of primary amino acid sequence and glycosylation patterns.  

According to Caliber, at commercial scale their facility can produce 100 million doses of H1N1 PMP product in 16-20 weeks, whereas similar tank-based bioreactor systems can take 6-9 months to produce the same quantity. This time-savings combines with upstream capital costs that are 10 percent lower and typically contain less automation. 

To read the full article, click here.

Custom Processing Services has a strong track record of contract manufacturing in the pharmaceuticals marketplace. And on November 11, 2011 that legacy was strengthened with the opening of a 42,000 square foot facility dedicated to GMP processing, with two unique GMP processing stations.  

Prior to this expansion, two similar rooms had been in operation for about 10 years at another of the company’s facilities. However, CPS soon realized that the increased number of requests for cGMP work had them at capacity.  

Along with investments in new production capabilities, CPS has looked to improve the quality of their operational processes. With this in mind the company recently unveiled a new safety system that is being applied to pharmaceutical grade products as part of the GMPs that are used on a daily basis. This includes a revised HACCP plan and all facilities now fall under a current ISO 9001 Quality Management System.  

As CPS looks to the future, they see opportunity in the changes that lye ahead. The constantly evolving needs of the pharmaceutical industry, in terms of new formulas, processes and regulations, means this contract manufacturer will need to continue to evolve and invest in order to keep pace. Their new facility and recent production equipment investments help reinforce that commitment.

To read the full article, click here. 

The Norwich Pharma Services manufacturing facility in Norwich, New York is as varied in its capabilities as it is its equipment investment strategy. The facility, which has been in operation since 1976, provides 375,000 square feet of operational space in producing approximately four billion solid oral dose units per year. With GMP-compliant equipment and production capabilities throughout, the facility can handle clinical, commercial and contract manufacturing within the same walls.  

From buying API to product distribution, the facility offers Phase I - III product development in solid oral dose tablets and capsules, as well as liquid doses. Manufacturing operations include blending, encapsulation and coating, as well as fluid bed, blister packing and liquid fill packaging.  

The facility can handle all phases of product development, starting with the pilot and scale-up stages, through production and including product packaging. And as the pharmaceutical industry continues to rely more and more on outsourcing, Norwich’s ability to handle early lifecycle projects has led to a number of long-term relationships.

To read the full article, click here.

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