Industrial Visit To Shilpa Biologoicals

Date: September 12, 2026
Venue: Shilpa Biologoicals private limited Belur industrial area Dharwad.

Industrial Visit To Shilpa Biologoicals private limited Belur industrial area Dharwad. Karnataka Industrial Area Development Board (KIADB). As part of experiential learning and industrial exposure, the students of SDM College of Pharmaceutical Sciences, SDM University, Dharwad, visited Shilpa Biologicals, Belur, Dharwad on 12 September 2026. In the presence of Faculty Coordinator Mr. Swaroop Jadhav and Mrs. Vidya Hiremath and special Thanks to Dr. Anil Tumkur for allowing us to the field visit and following are the visit details initially the infrastructure was shown in which it has Three separate buildings consisting of Administration Block, Manufacturing unit and R & D Department.

Initially the students were led to admin block where Mr. Aditya, manager of QA, sensitized about orientation to the organization and its manufacturing operations. As the students proceeded through the facility, the visit gradually unfolded as a journey through the complete lifecycle of a biological product from the development of the biological system to manufacturing, purification, quality control, packaging and warehouse, as the visit initiated the following departments were explored:

• PRODUCTION

  During the visit, Students were led through a glass corridor that provided a clear view of the production floor without compromising the sterile environment. Production officer explained that the facility utilizes both single-use bioreactors and stainless-steel fermenters, ranging from 50L to 3,000L scales. Students learned that manufacturing is divided into Upstream Processing (cell growth) and Downstream Processing (purification). This viewing area allowed us to see the physical scale of the equipment required to maintain precise temperature, pH, and dissolved oxygen for living cells.

• QUALITY ASSURANCE (QA)

  The QA team introduced us to their role as the “gatekeepers” of quality. We learned that QA at Shilpa Biologicals is integrated into every process rather than being a final inspection. Students were also informed about ALCOA+, GDP(Good Documentation Practice), also insighted about OOS, OOT, Incident, Event, Deviation, CAPA, Change control etc.. Their functions include managing the Quality Management System (QMS), overseeing Good Documentation Practices (GDP), conducting internal audits by CFD (cross functioning Dept.), and ensuring that all operations align with WHO-GMP and ICH guidelines.

• RESEARCH AND DEVELOPMENT (R&D)

  The R&D department serves as the foundation of the facility’s “Gene to GMP” workflow. During our interaction, the company executive explained that their process begins with Recombinant DNA (rDNA) technology, where they design a specific gene and insert it into a host (such as an animal cell line) to create a high-yielding ‘clone.’ This clone is then isolated and moved to the fermenters for massive multiplication, essentially turning living cells into factories that produce the therapeutic protein for the final drug. The Students were also insighted about the analytical techniques such as HPLC, GC, FTIR, KF, RPHPLC and various different spectroscopic and chromatographic techniques. Also visited the stability chambers. Of all the zones.( ZONE-I, ZONE-II, ZONE-III, ZONE-IV)

• PACKAGING

  The packaging area was explained as a critical final step for ensuring product integrity and traceability. The facility uses automated lines for vial labelling, plunger rod assembly for pre-filled syringes (PFS), and blister packing Students learned about the importance of visual inspection and the implementation of anti-counterfeiting measures like unique barcodes, Special Documentation numbers, Batch codes, etc were explained.

• STORAGE

  Personnel explained its function during our orientation. We were informed that biologics require strict cold-chain management, often stored at temperatures between 2°C to 8°C or even lower, with continuous temperature monitoring to prevent protein degradation. Some of the biosimilar products were kept under -189 0 C and compounds were labelled in unique style for the dispatch, and every dispatched materials recorded for the traceability.

Finally Mr.Hari kumar the HR provided us with the lunch in their canteen facility.