Stelis BioSource® CDMO Services for Biologics
Stelis BioSource® offers contract development and manufacturing (CDMO) services for recombinant proteins and peptides.
A division of Stelis Biopharma, Stelis BioSource® comprises state-of-the-art facilities and a growing workforce with more than 200 employees, 70% of whom are doctorate holders/masters. This high-quality workforce enables Stelis BioSource® to offer end-to-end capabilities, including early-stage development, process development and scale-up, formulation development, current good manufacturing practice (cGMP) processing, aseptic fill/finish, quality control, testing and analytical services.
Research and development (R&D) services
Set-up in 2014 with 22,000ft2 of lab space, Stelis BioSource®’s facility caters to the development of bioprocesses, formulations and supporting analytical methods to meet the high standards and requirements of its customers.
It is designed to handle up to Biosafety Level 2 (BSL-2) organisms and certified to meet the International Standardisation Organisation (ISO) 9001:2008.
The company’s early stage development offerings include clone optimisation for both microbial and mammalian expression systems, cell banking and characterisation.
Process development and scale-up services
Stelis BioSource® has invested in high-performance technologies that support robust and efficient processes for both microbial and mammalian systems.
The company’s upstream process development services include production clone finalisation and media screening, the optimisation of bioprocesses to establish high yields of target proteins, expressing proteins as inclusion bodies, providing soluble and periplasmic in various expression systems and establishing critical and key quality attributes for the process.
Stelis BioSource®’s downstream/purification process development services include establishing high-recovery purification processes of complex proteins; the development of filtration processes such as ultrafiltration, diafiltration and hollow fibre filtration; providing depth and crossflow modes, generating final drug substances in both liquid and lyophilised formats.
The company’s scale-up and tech-transfer services include optimising bioprocesses based on quality-by-design (QbD) principles, developing process analysis technology (PAT) for both mammalian and microbial processes, performing efficient tech-transfer to either the customers’ or Stelis BioSource®’s manufacturing facility, and providing process characterisation studies using scale-down models.
Formulation development services
Stelis BioSource® is experienced in developing injectable formulations in vials, prefilled syringes and cartridges.
Its capabilities include excipient screening and pre-formulation studies, stability studies at different temperature conditions meeting International Conference of Harmonization (ICH) guidelines, analytical characterisation of formulations and comparison studies and stability analysis.
cGMP manufacturing services
Stelis BioSource®’s integrated end-to-end facility in Bangalore, India, has the capability to produce simple and complex recombinant biotherapeutics from both microbial and mammalian cell culture systems.
The company’s facilities are designed to meet industry guidelines worldwide, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the World Health Organization (WHO).
Using microbial cell culture, Stelis BioSource®’s hybrid model has conventional SS fermenters (Sartorius) for fermentation and single-use and convention systems for downstream. The upstream capacities are 50l, 300l and 1,000l.
For mammalian cell culture manufacturing, the company adopts single-use technology (Merck-Millipore) for both upstream and downstream operations. This allows greater flexibility and reduces the likelihood of contamination, thereby better compliance and quick changeovers. The company will have up to four bioreactor train line-ups, including 50l, 200l and 2,000l.
The company is also capable of handling batch, fed-batch and perfusion fermentation; a pre and post viral segregation single-use flow path chromatography system (Merck Millipore); and viral-filtration, ultra-filtration and diafiltration.
Aseptic fill/finish services
Stelis BioSource® develops drug substances (DS) and active ingredients into stable formulations and fill/finish injectable formats. Its high-end filling lines are integrated with isolators to meet clinical and commercial requirements.
The pre-filled syringe and cartridge lines are both from Bausch & Strobel with integrated Steriline isolators and individual capacities of 10 million and 20 million per annum, respectively, on a single-shift basis.
The vial line is from Tofflon and features an integrated isolator and lyophilliser with a capacity of 10 million per annum on a single-shift basis.
The packaging line comprises labelling and syringe assembling machines from Bausch & Strobel, and a blistering and cartoning line from IMA with capacities of 10 million cartons per annum on a single-shift basis.
Stelis BioSource® also provides cold chain inventory management through dedicated warehouses at the facility.
Analytical development and validation services
Stelis BioSource®’s analytical lab features state-of-the-art equipment offering high-end analytical tools and methods for the characterisation of complex biologics and CDMO services.
The division specialises in performing orthogonal analysis using spectroscopic and spectrometric methodologies, which are developed in compliance with ICH, FDA and EMA guidelines.
Stelis BioSource® also performs validation services, in-process release testing, stability analysis, bioassay development and in-process analytics.
Quality control and testing services
Stelis BioSource® offers on-site cGMP analytical and microbiological testing services to support in-process and release requirements, as well as characterisation of reference and finished products to meet analytical comparability requirements.
The company’s testing capabilities include, raw materials, consumables and packaging materials, in-process and release testing, analytical method qualification and validation using ICH and the US FDA guidelines, as well as complex bioassays, including cell-based immunological assays, protein characterisation, microbiological testing and stability testing as per ICH guidelines.