issue2_2025_247BIOPHARMA

NEWS Shilpa Biocare Private Limited, a fully-owned subsidiary of Shilpa Medicare Limited (“Shilpa”), announces ahead of BIO Boston that it has secured a Europe-wide commercial supply agreement with Orion Corporation for Recombinant Human Albumin. Shilpa’s Recombinant Human Albumin – a key plasma protein used in various therapeutic applications – is currently under development and will be manufactured using a robust non-human expression system. This provides improved safety, scalability, and virus-free production, addressing some of the key limitations associated with human-derived albumin. Under the terms of the agreement, Orion will gain exclusive rights to distribute, market and sell Shilpa’s Recombinant Human Albumin in Europe, with Shilpa receiving development and regulatory milestone payments from Orion. “We are pleased to strengthen our strategic partnership with Shilpa by collaborating on this novel product,” said Satu Ahomäki, EVP Generics and Consumer Health, Orion Corporation. “Recombinant human albumin will strengthen our strategy and offering in value-add hospital generics, and we look forward to making it available across Europe.” At BIO Boston, Shilpa is expected to see increased interest from biopharma innovators, particularly smaller biotech firms, leveraging its development capabilities in oncology and biologics – with the CDMO having both commercial facilities for both mammalian and microbial production. Madhav Bhutada, Managing Director, Shilpa Biocare, added: “Partnering with Orion is a significant step in bringing our innovative recombinant product to patients across Europe and is a testimonial of our developmental and manufacturing capabilities to bring Recombinant Human Albumin to market. This alliance aligns with our mission to provide high-quality, affordable biologics globally, and we are confident this partnership will further accelerate our footprint in the regulated markets.” Shilpa Medicare signs commercial supply deal with Orion for innovative Recombinant Human Albumin Intensified fed batch platform delivers titers >25g/L Aragen, a leading contract research, development and manufacturing organization (CRDMO), announced that it will commence GMP manufacturing at its biologics manufacturing facility in Bangalore, India from July 2025. Aragen has successfully completed the facility and equipment qualification and demonstrated the productivity of its intensified fed batch cell culture manufacturing platform to deliver titers >25 g/L. Aragen biomanufacturing site completes qualification with first GMP batches in July 2025

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