Rooted in our decades of experience in the pharmaceutical industry, we have independently developed a large portfolio of technologies for the manufacturing of innovative biologics, biosimilars and generic versions of complex drugs which are successfully commercialized.
The technological platforms we have built and optimized over the years, enable us to cope with the most challenging processes and products.
The modern laboratories are equipped with diverse process development equipment and a wide range of analytical instruments, enabling efficient development from the very early stages to pilot-scale production. We have a proven track record of developing innovative products, biosimilars, and complex generics, entailing new process solutions, novel assays, and analytical methods, along with ingenious troubleshooting. Our technological platforms and scientific methodology applied in our research and development enable us to support front-edge solutions to a multiplicity of innovative and biosimilar product development.
Our analytical laboratories are designed for orthogonal testing of raw materials, drug substances, drug products, and intermediates of new biological entities (NBEs), Biosimilars/Biobetters, and chemically synthesized APIs. Our experienced analytical R&D team has vast expertise in supporting assay development and testing during all stages of drug development.
From the earliest stage to pilot-scale production
New process solutions and analytical methods
KinBio’s cGMP manufacturing plant consists of 2,000 sqm of separate suites for the manufacturing of multi-product biologics bulk drug substances (BDS) and chemical synthesis active pharmaceutical ingredients (APIs). The plant is equipped with state-of-the-art manufacturing lines enabling the manufacturing of kilo-batches under the highest quality standards. The manufacturing facility meets IMOH, EMA and US FDA regulations and is routinely inspected by these agencies. Our clients are always welcome to visit and audit our manufacturing lines, QC laboratories and quality system.
Biopharmaceutical Facility
KinBio’s multi-product biopharmaceutical manufacturing suite is based on multiple bioreactors of different scales, capable of batch and fed-batch processes, and a compatible commercial scale downstream equipment. It is designed to yield substantial annual BDS quantities of multiple products and it is expandable to enable future growth.
In addition, the production suite is equipped with an automated, cutting-edge perfusion bioreactor system for the production of hard-to-express recombinant proteins.
Our FDA-approved sterile finished dosage form production plant is designed for fill and finish of drug products including pre-filled syringes, multiple-dose injection systems, and lyophilized or liquid vials.
Complex Generics Facility
Our chemical synthesis manufacturing line is equipped with new, tightly controlled equipment, that enables managing sensitive processes to produce large quantities of highly delicate and complex materials.
Our technological capabilities include profound knowledge in working with different animal host cells and expression systems, media optimization to control efficient protein expression and modify post-translational modifications such as glycosylation patterns, different modes of upstream processes, improving protein purification steps, along with in-depth protein analysis and characterization.
Our processes are recognized by increased yields of highly-active products, making them competitive and with consistent product quality.
