How JMP is Used in the Pharma and Biotech Industries
*Internal use only*
The Pharma and Biotech sectors require excellent process understanding to ensure that finished products are produced with consistent properties. JMP is embedded at the centre of some of the world’s largest and most innovative pharmaceutical and biotech companies to explore process and lab data, understand sources of process variation, learn more from root-cause investigations and optimize processes and experimental design. These capabilities allow problems to be solved quickly, driving increased product and process quality.
Who uses JMP in these industries?
- Researchers across chemistry, biology, and formulation
- Pharmacists and clinicians running clinical trials
- Data engineers
- Quality analysts
- Manufacturing teams
What problems do these users have?
As these users span a range of activities, from early research to full scale production, there are a wide array of problems that they’d wish to resolve. Some of these are:
- process understanding and improvement
- Optimising their experimental workflows
- Ensuring regulatory compliance for their products
- Fast analysis of large volumes of data
- Correct use of statistical techniques
What do they use JMP for?
Researchers and analysts need to make improvements to current products and create new products according to demand. The correct use of statistics helps in decision making, reducing waste.
The management of the quality and quantity of products used in pharmaceutical production must follow strict limits specified by regulatory bodies. Understanding all the components involved in the analysis as well as the variables that affect production ensure agility and quality for the company.
The main statistical techniques used by these industries are:
- Design of Experiments
- Statistical Process Control
- Stability and Shelf Life Analysis
- Quality by Design (QbD) & Robust Process Optimization
- Exploratory data analyses and modelling
Customer stories
Ono Pharmaceutical
Full article available here
Ono has long worked to develop revolutionary new therapies that embody the company’s core philosophy, “dedication to man’s fight against disease and pain.” For example, Ono’s anti-PD1 monoclonal antibody, OPDIVO, recently received global attention as a wonder drug in the treatment of cancer.
Ono, like many of its counterparts in the industry, has accelerated its efforts to introduce quality control to the production of pharmaceutical ingredients. There was a time when all that mattered about a drug was its efficacy. But in the modern era, there is also a product quality mandate. The introduction of new guidelines known as the ICHQ Quartet and promulgation of the Quality by Design (QbD) concept have further accelerated the demand for detailed investigations into product quality.
Fujifilm Diosynth Biotechnologies
Full article available here
Recognising that customers and health care providers have come to expect products that are both high-quality and cost-effective, contract development and manufacturing organization Fujifilm Diosynth Biotechnologies (FDB) is now providing its scientists a suite of state-of-the-art statistical and data science tools that aid in decision making, leading to both more efficiency overall and more replicable science. This move constitutes a recognition of scientists’ growing need for statistical capability in the lab.
As part of FDB’s toolkit is the Functional Data Explorer (FDE) platform available in JMP Pro. FDE is, essentially a data transformation tool that helps scientists to prepare data for analysis, including for DOE. This comes in particularly handy in biologics development where much of the data – sensor data, transactional data or chemical spectra for example – is presented as a function. This makes it a crucial tool for pre-processing data for exploratory analysis, creating surrogate models or reducing dimensions.
“Although there are a lot of complicated calculations and coding going on in the background, the very user-friendly platform in JMP makes it quite easy to use.” Somaieh Mohammadi, Staff Scientist, FDB
Sales stories
Shanghai Henlius Biotech
JMP Clinical $118,906
Shanghai Henlius Biotech, a global biopharmaceutical company that develops high-quality, affordable and innovative biologic medicines for oncology and auto-immune diseases, recently acquired 20 JMP Clinical licenses.
Henlius has used JMP in its chemistry, manufacturing and controls (CMC) department since 2017. Jessica Wang used this relationship to get the name of a contact in Henlius’ medical department so that she could discover that group’s particular needs. After collecting the requirements from the medical managers, Jessica invited Wenjun Bao to come to Henlius to give an onsite demo of JMP Clinical. Jessica says, “The customer was very moved to have Dr. Bao from the US headquarters give them a demo in person.”
Jessica and Alex Xu kept the conversation going, arranging follow-up Q&A meetings with the potential users. Jessica says, “It was important to keep communications with medical users, managers and directors open so we could know how they felt about JMP Clinical. We were able to demonstrate that JMP Clinical is more than an analysis tool, that it can be an important, long-term medical review system for the company.”
Key Players: Wenjun Bao, Chuchu Chen, Jessica Wang, Alex Xu
Regeneron Pharmaceuticals
JMP Live server - $53,400
Regeneron Pharmaceuticals, a leading biotechnology company and longtime JMP customer, recently added a JMP Live server for up to 100 users.
Regeneron had been using a series of ad-hoc methods to manage and present data in a manufacturing environment but was looking for a way to facilitate collaboration and education initiatives at its Rensselaer, NY, manufacturing location.
Mike Anderson says, “The statistics group at the Rensselaer location championed the adoption of JMP Live as a new solution to the existing problems of how to collaborate and document analyses, whilst facilitating the educating of new hires. Since we had been using JMP Live in some capacity in almost every interaction with Regeneron, we demonstrated how easy it was to share demo results in near-real time. By using JMP Live with them, it helped them become aware of the product’s capabilities without creating a formal sales situation.”
Key players: Mike Anderson, Tracey Bailey, Brendan Leary, Dieter Pisot, Dan Valente
Do we have any good demo material?
There are some excellent demo materials available on the demo resources page. The extensions to the tablet demo, for instance this Functional Data Explorer example.
There is less specific biotech demo material available, but there are some excellent options in the Mastering JMP materials for the Analyzing Genetic Diversity and Applying Genomic Selection Methods session and in the Bioassay Training session. Both of these sessions supplement the wealth of demo material covering techniques with broad appeal such as DOE, model building, and quality techniques.
Relevant Resources to learn JMP
JMP offer a lot of resources for our users to help build your knowledge and skill set. You can find an effective way to use JMP by reading whitepaper, and attending webinars. Here are some good materials for the pharma and biotech users:
Resources used for this article
https://www.jmp.com/en_ca/support/jmp-resources-for-pharma-biotech-industries.html
https://www.jmp.com/en_ph/whitepapers/jmp/pharmaceutical-quality-by-design-methods.html
https://www.jmp.com/en_us/customer-stories/ono-pharmaceutical.html
https://www.jmp.com/en_ca/support/jmp-resources-for-pharma-biotech-industries.html
Demo Resources by Vertical Markets - JMP System Engineers - SAS R&D Confluence
JMP Sales Stories - JMP - SAS R&D Confluence
