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Center Set To Support the Delivery of Novel, High-quality Therapeutics

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We recently spoke with Thermo Fisher Scientific's Eric Grumbach, to learn more about the opening of the company's new Pharma and BioPharma Center, located in Shanghai, China. The center is set to support the rapid delivery of novel and high-quality therapeutics by providing expertise in critical analytical techniques and specialized workflows.

Laura Lansdowne (LL): Could you elaborate on what is meant by “Pharmaceutical Quality by Design” and how does the opening of the Pharma and BioPharma Customer Solution Center support this?

Eric Grumbach
(EG): Pharmaceutical Quality by Design (QbD), which has been advocated by the pharmaceutical industry and numerous regulatory bodies, is a concept implemented by medicine manufacturers to ensure the quality of medicines, by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines.

Having more
detailed information early in the drug development process allows for deeper analytical knowledge of the candidate molecules, which can then help informed decision-making – not only accelerating the whole development process, but also ensuring quality is considered at each individual step. The opening of the Customer Solution Center will allow access to advanced analytical instrumentations, workflows and expertise which can help analytical scientists in the pharmaceutical and biopharmaceutical industry to build-out and leverage deeper characterization and control strategies to support the QbD approach for their own products.

Molly Campbell (MC): How will the opening of the Pharma and BioPharma Customer Solution Center look to overcome some of the key challenges in drug development?

Complex biopharmaceuticals, such as monoclonal antibodies, can be very heterogeneous as they may be subject to alterations – caused by posttranslational modifications and degradation during storage. Key challenges in drug development arise when there is difficulty in assuring the quality of a candidate molecule, due to some of its structural characteristics. Ensuring detailed structural characterization of the molecule and implementing reliable process controls to produce the drug with the desired structure is therefore very important. This can be achieved using advanced analytical techniques, such as ultra-high-pressure liquid chromatography and high-resolution accurate mass (HRAM) mass spectrometry. Other related challenges include cost and time investment.

More comprehensive insights can be harnessed using HRAM MS when compared to using a combination of several traditional chromatographic techniques, such as CEX, rCE-SDS and ELISA. HRAM MS involves using one powerful method instead of many, saving time and money on the investment to buy and maintain instrumentation, produce data and validate several methods.

The Pharma and BioPharma Customer Solution Center will facilitate faster and better access to expertise in critical analytical processes and specialized workflows using advanced analytical techniques. Getting reliable answers faster helps speed up the development of life saving therapeutics.

LL: Could you describe some of the best-in-class analytical technologies you will be bringing to laboratories?

Thermo Scientific™ Q Exactive™ Plus Hybrid Quadrupole-Orbitrap™ Mass Spectrometer with BioPharma Option has been a proven workhorse for the biopharma analytical labs, which, when coupled with the Thermo Scientific™ Vanquish™ Duo UHPLC System provides a best-in-class technological LC-MS platform for full characterization of biopharmaceutical proteins. With the added productivity gain of a dual channel UHPLC system, key analytical workflows can be used in a more streamlined manner when thinking about efficiency and sample throughput, which are often required for top laboratories.

MC: How will the center encourage collaboration?

The Customer Solution Center is an integral part of Thermo Fisher Scientific’s global network. Chinese colleagues work closely with scientists in Europe and North America, ensuring expertise is available not just locally, but through internal collaborations within Thermo Fisher’s global expert network. This will allow for an ongoing partnership with local regulatory labs to introduce and support our analytical workflows. The Center offers laboratory and office space for long-term collaborating projects, training courses and seminars, which will facilitate better knowledge sharing.

LL: How will the center facilitate the delivery of novel and high-quality therapeutics?

This center is located at Zhangjiang, Shanghai, and a thriving biopharma region in China. It provides easy access for leading industry collaborators, enabling them to connect and solve real-world analytical challenges together. With best-in-class equipment, software and support services delivered from experienced scientists, we have the structure and capabilities to advance our customers’ knowledge of the resources, quality and efficacy of their drug products.

Eric Grumbach was speaking with Molly Campbell and Laura Elizabeth Lansdowne, Science Writers for Technology Networks. 

Interviewee: Eric Grumbach holds the position of director, Business Development and Marketing, Chromatography and Mass Spectrometry, Thermo Fisher Scientific.