NEWS FROM BRL

We are always pushing the frontier of technology’s impact in the world of biologics. We feel that modern technology allows easy crossover of ideas across borders and cultures. Our achievements and our knowledge are to be shared with the community and the technology ecosystem.

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Subcutaneous Trastuzumab Case: Achieving concentration of 250mg/mL at a syringeable viscosity of 18 cP.

Using only 2 GRAS excipients, BRL has achieved concentrations of over 250mg/mL with viscosities less than 20cP. Stability data - both in-house and from  third party CROs, shows that this high-concentration, low-viscosity formulation of Trastuzumab is physically, chemically and biologically  stable over a six month duration at normal temperatures. PK/PD studies show comparable efficacy to the innovator Trastuzumab. This could potentially result in a low-cost, low-volume, high-concentration, subcutaneous version of Trastuzumab. 

Worldwide patent granted for "High Concentration Protein Formulations with Reduced Viscosity".

With this new patented technology that holds great potential as a 'Platform' technology, BRL aims to help large and small biopharmaceutical companies achieve syringeable viscosities for high-concentration protein biologics like monoclonal antibodies. This will pave the way for low cost, low-volume subcutaneous monoclonal antibodies for the treatment of various cancers and autoimmune disorders.

Dr. Bhami Shenoy envisions a bright future for biologics in India.

With multiple patents, publications and grants under his belt, Dr. Bhami Shenoy is one of the foremost scientists in the field of protein biologics in the world. With over 11 years at Altus Pharmaceuticals and 5 years at ProCrysta in the USA, Dr. Bhami decided to give back to his homeland - India, everything he gained through his experiences. His ideology is, "Never give up and always help others". He strongly believes that nothing in life can be achieved without hard work. In the next 5 years, he aims to bring to market at least one high-concentration formulation and one vaccine with the hope that BRL can help as many people as possible with these technologies.

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Purification of Trastuzumab using BRL's crystallization technology.

In a recent study conducted by BRL, the purity and overall characteristics of trastuzumab were compared between Protein A purification (conventional method) and crystallization (BRL's Technology). 

As a result, comparable purity was observed between the two in HPLC as well as SDS-PAGE tests

Purification of protein biologics by crystallization.

50-80% of protein manufacturing costs are incurred during the purification and subsequent steps especially Protein A chromatography. This is cost intensive process and adds significant amount of time to the manufacturing process. 

BRL's technology allows for protein purification by crystallization can be used on its own or for the elimination of Protein A chromatography  enabling continuous bioprocessing with significant reduction in cost (up to 70%) and time.

BRL's High Concentration Protein Formulation Technology for better biologics.

High-dosage biologics like monoclonal antibodies (mAbs) have significant challenges due to inherent aggregation, instability and difficulty of administration in high concentrations.

Over 80% of these biologics are administered intravenously over long periods of time. This causes a significant increase in cost along with greater inconvenience for patients.

BRL's patented viscosity-reduction technology uses only two GRAS excipients and has the potential to convert a majority of these IV administered mAbs to safe, subcutaneously delivered, high-concentration, low-volume injections.