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Case Studies
> Buffer Feed (Chromatography)
> Buffer Preparation (Liquid – Liquid Mixing)
> Bulk Drug Substance Fluid Transfer
> Cell Clarification (Post Centrifugation)
> Cell Culture Media Charge
> Cell Culture Sampling (Bags)
> Cell Culture Sampling (Bottles)
> Cold Storage / Transport
> Final Fill (C-Flex®)
> Final Fill (Sani-Tech® Ultra) #1
> Final Fill (Sani-Tech® Ultra) #2
> High Pressure Filtration
Case Studies

Buffer Feed (Chromatography)

A bioprocess engineer at a contract manufacturing organization (CMO) facility for monoclonal antibody therapy manufacturing was unhappy with their current buffer feed chamber due to an output flow rate that could not keep pace with their chromatography column process requirements. This inefficiency resulted in process delays and potentially compromised batches of high value product. If continued it would jeopardize future opportunities for CMO with their client.

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Buffer Preparation (Liquid – Liquid Mixing)

A vaccine developer was looking for a cost effective single-use solution for optimizing a buffer preparation process via liquid-liquid mixing used in their downstream process. Their process involved a buffer dilution step and fluid delivery. The customer’s initial concern in implementing a single-use mixing system was that poor liquid-liquid mixing performance may result when compared to their existing multi-use stainless steel system.

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Bulk Drug Substance Fluid Transfer

A Bioprocess Engineer at a Monoclonal Antibody Therapy Developer was responsible for employing a sterile process for bulk drug substance (BDS) fluid transfer at their new facility. The objectives of this product development included 1) maximize time efficiency of the critical fluid transfer process, 2) measure in-process pressure, 3) no visible loose particulates USP <788>, 4) sterile (10-6 SAL) and aseptic-processing capability and 5) low endotoxin levels 0.25 EU/ml (USP 85). The customer’s implied risk was extremely high during the BDS critical fluid transfer phase of bioprocess. The single-use system requested must provide the very best in fluid path integrity assurance.

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Cell Clarification (Post Centrifugation)

A principal scientist at a vaccine contract manufacturer (CMO) was commissioned to address a downstream challenge. An improper sterile filtration system set-up impeded their recovery process following cell culture harvest post centrifugation. This process was frequently clogged during this cell clarification step increasing CMO’s bioprocess time and also at the expense of reduced product yield. Saint-Gobain was asked to develop a sterile cell clarification (post centrifugation) and recovery chamber that would mate to their existing cylindrical flat bottom tanks.

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Cell Culture Media Charge

A Bioprocess Engineer at a contract manufacturing (CMO) facility faced various product contamination challenges using their current stainless steel cell culture media transfer lines as identified by elevated levels of bioburden prior to inoculation.

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Cell Culture Sampling (Bags)

A process engineer from an animal healthcare manufacturer faced contamination risks due to their open environment sampling procedure and desired a sterile closed system for microbiology analysis during cell culture. If cell culture was falsely identified as contaminated due to a poor sampling process then batch loss would result.

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Cell Culture Sampling (Bottles)

A monoclonal antibody developer required a sterile / aseptic sample collection system that supported their upstream cell culture process. They were currently using a sample collection procedure that exposed contents to their open manufacturing environment that could potentially result in sample contamination. Also, steam line purge prior to sample collection caused added concern that reduced cell counts and potentially denatured proteins may result during sample collection.

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Cold Storage / Transport

A monoclonal antibody developer was systematically collecting bulk drug substance (BDS) in an open top polycarbonate (PC) carboy prior to delivery to drug product site. Upon initial receipt of the new containers, the developer would clean in-house to remove all visible loose particulates and then autoclave before collection. Their BDS containment task force realized the potential risk associated with using their existing open-system design and sought out a supplier to develop a fully integrated closed-system. This system would be subjected to a low of -70°C at initial freeze/transport and then thawed to a 22°C. The desired single-use system materials must be suitable for gamma irradiation and delivered to the customer for aseptic BDS collection. The customer implied risk was extremely high during this BDS storage and transport phase of bioprocess. The single-use system must provide the very best in product integrity assurance.

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Final Fill (C-Flex®)

Cancer drug manufacturer experienced repeated air/fluid leakage and variable volume dose delivery during their final fill operation. This failure resulted from a mechanical tubing assembly with barbed fittings that was provided by their current supplier. It was critical that the new single-use assembly replacement could endure prolonged peristaltic pump stress and achieve the desired small volume dose delivery. The implied risk was very high during this final fill operation as two production batches had been previously lost due to original mechanical assembly failure. Further batch lost was not an option.

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Final Fill (Sani-Tech® Ultra) #1

The manufacturer of a final fill machine recommended replacing existing stainless steel lines in their customer’s vaccine manufacturing process with Saint-Gobain single-use systems. It was critical that this customized single-use system be easily integrated into their existing final fill operations consisting of a recirculation process to keep the partical vaccine in suspension and to obtain repeatable small volume fill delivery. The development timeline was crucial at this stage of bioprocess and needed to align with upstream cell culture operations.

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Final Fill (Sani-Tech® Ultra) #2

A process engineer at a contract manufacturing organization (CMO) was faced with inconsistent dose fill volumes during final fill operations for monoclonal antibody production and explored viable solutions by incorporating single-use technologies. Material compatibility and elimination of loose visible particulates were critical to the success of their bulk drug substance final fill campaign.

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High Pressure Filtration

A vaccine developer’s downstream filtration process required laborious Clean-in-Place (CIP) / Steam-in-Place (SIP) steps in support of their validation process. They desired a customized plug-and-play single-use system that would streamline their biomanufacturing process by replacing their current multi-use equipment. They contacted Saint-Gobain to develop a single-use system that would mate to their newly designed filtration cart and also have the ability to withstand a pressure of 50 psi.

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