Lyophilization is process of freeze-drying where in the product is first frozen at low temperature and then dehydrated through sublimation. There are three phases of lyophilization that involve the process of freezing, primary drying, and secondary drying. Pharmaceutical companies often adopt this process so as to increase the shelf life of antibiotic, protein–based drugs, vaccines, etc. These are also used for the production of tablets and wafers (orally disintegrating tablets).
Key players are involved in expanding services related to lyophilization for biopharmaceuticals which is expected to propel the global lyophilization services for biopharmaceuticals market growth. For instance, in May 2015, Symbiosis Pharmaceutical Services expanded its services into aseptic and low bioburden clean room dispensing of bulk materials. It also improved the cycle time, labelling, controlled temperature and storage of the lyophilized processed products. Earlier it used to offer services only for filling the vials.
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Furthermore, strategies adopted by key players are expected to drive the global lyophilization services for biopharmaceuticals market growth. For instance, in November 2018, Dalton Pharma Services, a contract developing and manufacturing company entered into a licensing agreement with ExCellThera Inc., a biotechnology company. In this agreement ExCellThera Inc. got access for the formulation (filling and finishing) of its medications from Dalton Pharma Service’s manufacturing (including lyophilization) facility.
Furthermore, in April 2018, Lyophilization Services of New England, a contract development and manufacturing organization acquired a fill/finish manufacturing facility (business line) of PSC Biotech, a biotechnology service provider firm. This manufacturing facility involves vial filling, lyophilization services, secondary packaging, and quality control services. Acquisition allows Lyophilization Services of New England to expand its manufacturing capacity and also allows to offer new services. These factors are expected to influence the global lyophilization services for biopharmaceuticals market growth.
North America is expected to hold dominant position in the global lyophilization services for biopharmaceuticals market over the forecast period. Research and development by key players and other organizations is expected to have a positive impact on the global lyophilization services for biopharmaceuticals market growth. For instance, in January 2018, a group of researchers from Purdue University (Indiana) and industry key players (names undisclosed) partnered to develop a new lyophilization process. The group of researchers intends to advance the technology present in lyophilization, so as to make it less time-consuming and more convenient. This factor is expected to support the global lyophilization services for biopharmaceuticals market growth.
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Demerits associated with lyophilization process may hamper growth for the global lyophilization services for biopharmaceutical market growth. Freezing method involves lowering of the temperature of products, so as to eliminate the microbes, however, some microbes such as psychrophiles are able to sustain cold temperatures. Silicone oil is used for heating and cooling of shelves in the freeze dryer. Leakage of this oil can lead to contamination of the products. Hence, such spoilage and leakages may lead to contamination of products and thereby is expected to hinder the global lyophilization services for biopharmaceuticals market growth.
Some of the major players operating in the global lyophilization services for biopharmaceuticals market include Dalton Pharma Services, GILYOS GmbH, Jubilant HollisterStier LLC, Biopharma Process Systems Ltd., Piramal Pharma Solutions, Biofortuna Ltd., Symbiosis Pharmaceutical Services, Baxter Healthcare Corporation, Lyophilization Services of New England, and Lyophilization Technology Inc.
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