Micro-organisms in Macro-reactors! Fermentors for all applications
Praj Hipurity |
“You’ve got to start with the customer experience and work back towards the technology – not the other way around.” – Steve Jobs
Fermentation is a complex and iterative process with many interdependent parts. One is concerned with not just an organism and its genetics, but also how the physiology of that organism interacts with the fermentation process one is developing. Beyond the biological challenges of developing a process, one has to consider the financial constraints of making a process and company profitable by accessing fermentor capacity, increasing titre, decreasing costs and controlling scale-up risks. This also involves risk analysis with respect to:
Based on these four factors, scale of fermentors varies widely from 10 L to 3,50,000 L spreading across various applications like Biosimilars, Biotherapeutics, Vaccines, Enzymes, Nutraceuticals, API & Antibiotics. Interestingly, features for all fermentors remain same:
A key word we forget here is RFT (Right First Time) facility design EARLY in the project, capable of delivering all of the above. We are learning to tell all our industry friends in Biopharma – Independent of your product & scale, the key features are NOT negotiable, as your market comprises of living beings. All volumes of fermentor have different set of challenges in their design, construction, testing and validation. Few well-known challenges are:
- Space constraint in plant: At times high capacity fermentors are built and tested at site.
- Jacket coverage, jacket type & cooling coil for temperature control
- Uniform heat transfer for assured sterilization
- Adequate mass transfer for yield
- Containment : end-to-end
- Cleaning validation
- Recipe-based automatic operation
- Event log & data security
In addition to this, fermentation experts feel comfortable, if they are able to automate the ‘Pre’ & ‘Post’ of fermentation seamlessly. This includes integrating distribution of CIP, WFI, Purified water, Clean Steam & media before fermentation and integrating to harvest tank, microfiltration & centrifuge after fermentation.
Solution – Shifting from Product to Market & using the Right scale of fermentor
As your market comprises of patients, so complying with product quality and regulatory standards are of paramount importance. Your product is an outcome of process that is developed. This process can be built, tested & validated using technology from Praj HiPurity. Based on your product and scale, Praj HiPurity can offer fermentors from 10 L to 3,50,000 L.
Integration of utilities, upstream & downstream equipments with fermentors have to be anticipated and built in design before orders are released , with clear mechanical, process, software & validation boundaries, as well as handshakes well defined. This way of pre-empting the needs and then incorporating them early in design, helps to achieve:
- Seam-less operation
- Sterility & Containment
- Consistent yield
- Data Integrity
We at Praj HiPurity have tried to ingrain this in our way of life, based on our varied experiences with clients, suppliers and consultants.
Nothing is as fast as TRUST. You can trust Team Praj HiPurity to assist you with right solution early in design phase either Pre-order or Post-order engineering.