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Large Molecules CDMO Infrastructure Large Molecules CDMO Infrastructure

Large Molecules CDMO Infrastructure

Integrated operations with dedicated facilities for the development and manufacturing of a wide range of large molecules.

At APSL, manufacturing of both Drug Substance (DS) and Drug Product (DP) is done on-site. The manufacturing is supported by in-house physiochemical and bioanalytical development. The development and manufacturing are supported with utility blocks, warehouse spaces, and R&D labs. We are well equipped with WHO-GMP-qualified plants. We have GMP approvals from various leading agencies including PIC/S authorities. Our facility is well equipped with state-of-the-art robotics and high throughput instrumentations such as ClonePix, Octet, CEDEX, Maxcyte, and Ambr.

We have non-GMP manufacturing capability in the range of 50L – 200L and GMP manufacturing capability over a wide scale - 50L to 2,000L in single use bioreactors. We offer technological flexibility such as –

Batch Fed-batch Perfusion in single use/stainless-steel reactors

We provide an integrated approach to safety and quality management systems, leveraging a pan-organizational experience. We are a one-stop shop across the product life cycle – proof of concept to commercial.

We can support large scale vaccine manufacturing – 2x1KL per batch run in a single-use platform. Clinical and commercial manufacturing is done at 200L and 1000L scale with the ability to manufacture in stainless steel as well as single- use technology.

State-of-the-art cGMP viral vector manufacturing (scales up to 2 X 1000 L) facility is being commissioned and clinical grade rAAV production process optimization is under development. 10KL of cell culture manufacturing capacity with expansion initiatives under way to double capacity by setting up a new cell culture manufacturing plant, fill finish manufacturing plant, clinical material manufacturing plant, and supporting utilities.

We are committed to data integrity and reliability based on digital data recording in accordance with GAMP 5 requirements. We follow documentation and report writing to comply with regulatory filing with FDA, PMDA, and EMEA. Our development is supported by digital infrastructure.

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Connect with our scientific experts for your drug discovery, development, and manufacturing needs

We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.

Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.

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