Biologics
At PharmSky, we transform complex biologics into clinical-ready products. With seamless support across development, manufacturing, and analysis, we deliver the expertise and speed you need to move confidently from discovery to clinic.
Biologics Manufacturing and Analytical Services
PharmSky’s biologics team supports the development and production of recombinant proteins, antibodies, and other biologics suitable for pre-clinical and clinical applications. Following the principles of current GMP and relevant regulatory guidelines, our team manages the projects by working closely with our partners to ensures that all biologics are manufactured, formulated, and tested to meet the highest standards of quality and patient safety.
Our Biologics Development and Testing Process
We offer end-to-end project support for upstream and downstream processing, formulation development and optimisation, and analytical testing. Our scientists work closely with clients and partners to design scalable bioprocesses that ensure product consistency and regulatory compliance from early-stage material through to clinical manufacturing. PharmSky can assist in developing or refining formulations, scaling processes, and establishing validated methods suited to your molecule and intended clinical phase.
Analytical and Stability Testing
Our TGA-certified analytical laboratory performs comprehensive testing for identity, purity, quality and stability of drug substances and drug products. We develop and validate analytical methods, supporting both in-process control and final product release. Stability studies are conducted under ICH-compliant conditions to ensure long-term product integrity and support regulatory submissions.
GMP Storage and Logistics
Our secure, temperature-controlled GMP storage ensures proper handling and traceability of raw materials, intermediates, and final products. Materials are managed within our validated quality system, with full documentation and chain-of-custody controls. PharmSky also provides coordinated logistics support for sample transfer, clinical shipment, and retention storage following project completion.
Facilities and Equipment
Located in Melbourne, Australia, PharmSky’s ensures that the biological materials are handled in compliance with regulatory and biosafety standards and ensures that dedicated cleanroom environments, controlled access, and validated equipment are used and maintain aseptic conditions during upstream and downstream activities. The facilities and the bioprocessing equipment support diverse biologic formats (including recombinant proteins, antibodies, vaccines or enzymes) at pilot and production scales.
Customer Value
Pharmsky leverages its TGA-licensed GMP analytical expertise and a network of specialised biologics partners to deliver integrated solutions for protein and antibody development. From analytical characterization to formulation and coordinated small-scale manufacturing, we help biotech innovators advance their biologics with quality and confidence.
Why Choose PharmSky To Partner With?
PharmSky’s scientists spent many years successfully developing generic and value added products for some of the biggest pharmaceutical companies in the world. Our experience and understanding of the complexities of the generic development process means will help you avoid common mistakes and get your product approved more quickly.
Contact Us Today
Fast track your development with our extensive services. Get in touch so we can discuss your requirements.
