The latest from CDMOs, CMOs, and suppliers featuring Lonza, Bora, and Shilpa Biologicals. 

Chemicals/Chemical API Manufacturing 
* Lonza launches API Development Platform 
Biologics Manufacturing 
* Shilpa Biologicals Opens New Bioconjugation Suite 
General 
* Bora to Expand Biologic Mfg Facility, Add Automated Fill-Finish Line 

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Chemicals/Chemical API Manufacturing 

Lonza launches API Development Platform 
Lonza has launched its new Design2Optimize platform to enhance process development and manufacturing of small-molecule active pharmaceutical ingredients (APIs).  

The platform is based on an optimized design of experiments (DoE), a statistical approach to process and reaction condition optimization. The platform is designed with the goal of accelerating the development timeline of small-molecule APIs. The model-based platform combines physicochemical and statistical models with an optimization loop to enhance chemical processes with fewer experiments than traditional statistical methods, according to the company. Developed with the Fraunhofer Institute for Industrial Mathematics in Kaiserslautern, Germany, the platform helps drug developers to build predictive models at speed, even for complex or poorly understood reactions where the mechanism is not definitively known. By generating a digital twin of each process, the platform enables scenario testing in situ without the need for further physical experimentation, according to the company.  

Source: Lonza 

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Biologics Manufacturing 

Shilpa Biologicals Opens New Bioconjugation Suite 
Shilpa Biologicals, a CDMO, has opened a bioconjugation suite at its Dharwad, India, site. Located adjacent to the company’s existing commercial biologics manufacturing facility, the suite is currently undergoing validation and is expected to begin onboarding client programs by September 2025. 

The new bioconjugation suite is built to support the manufacture of antibody drug conjugates and other advanced bioconjugates and includes 200-L single-use bioconjugation reactors and a lyophilization capacity of up to 65 kg. Complementary development laboratories will provide process development, analytical characterization, and both early and late-stage scale-up capabilities. For final dose requirements, Shilpa’s Hyderabad site is equipped with multiple isolator-based fill–finish lines dedicated to cytotoxic products. 

Source: Shilpa Biologicals 

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General 

Bora Expanding Biologic Mfg Facility, Adding Automated Fill–Finish Line  
Bora Biologics has announced an expansion of its US commercial biomanufacturing facility in San Diego, California, and Bora Pharmaceuticals is adding a new fill–finish line at its site in Baltimore, Maryland.  

The expansion adds 8,075 square feet of GMP manufacturing space to the San Diego biologics manufacturing facility, comprising a upstream mammalian cell-culture hall, harvest suite with two inoculation rooms and an in-process testing room, a capture suite, and a downstream processing suite. This includes 6,950 square feet of new construction and 1,125 square feet of revisions to the existing GMP space. 

The expanded facility will feature two 2,000-L Cytiva XDR bioreactors and seed train. The upstream hall’s design allows for future bioreactor expansion up to the 5,000-L scale. The downstream process suite is engineered for up to 5,000-L high-titer cell culture processes 

Bora Biologics’ San Diego facility currently offers a range of GMP manufacturing suites, including 50-L, 250-L and 1,000-L single-use bioreactors dedicated to mammalian cell culture, and a dedicated microbial GMP suite equipped with a 150-L stainless-steel fermenter and a 300-L single-use fermenter expansion capability. An addition of two 2,000-L single-use bioreactors is planned in the first quarter of 2026.  

Separately, the installation of the new fill–finish AST GENiSYS C automated vial, syringe, and cartridge line at Bora’s Baltimore facility will take place over the course of the next year (as reported in May 2025). The new line will operate under full isolator conditions and is suited for clinical and small-scale commercial supply for high-value substances. 

Source: Bora (biomanufacturing expansion) and Bora (fill–finish expansion)