Mar 06, 2026
.webp "Orphan Drugs and Advanced Therapies Formulation Research")
As drug pipelines diversify and patient populations become more specialized, formulation R&D plays a critical role in bridging discovery and commercialization. Whether working on an orphan drug with tight development timelines or an advanced modality with complex manufacturing requirements, sponsors increasingly seek CDMO partners capable of delivering both speed and scientific rigor.
At Piramal Pharma Solutions, formulation development is structured to support agility without compromising scalability or regulatory rigor.
Breakthrough and orphan designations demand rapid dosage form development and early clinical supply. To support this need, Piramal established its PPDS (Piramal Pharmaceutical Development Services) site in Ahmedabad, India, a Centre of Excellence for formulation development and clinical batch manufacturing of oral solid dosage forms.
This site enables rapid formulation development and the manufacturing of clinical trial materials for Phase I and II programs, with flexible batch sizes ranging from 100 grams to 50 kg. Potent drug-handling capabilities and flexible equipment enable programs to scale efficiently before transfer to integrated commercial manufacturing sites within the global network.
High potency oral solid dosage (OSD) development demands strong containment and scalable process control. Continuous technologies, such as roller compaction, enable flexible batch sizes while integrating containment before and after compaction and milling.
In many cases, scaling is achieved by extending run times rather than redesigning the process. With the right equipment selection and in-process controls, manufacturers can maintain containment integrity, demonstrate process control, and meet regulatory expectations as programs move from R&D to commercial production.
.webp "person working in factory")
Controlled-release technologies continue to evolve, with innovations including:
Piramal';s integrated drug substance and drug product facility in Morpeth, UK has expanded tablet-in-tablet capabilities, enabling differentiated release within a single dosage form.
Additional technologies include micro-tablets for weight- or age-based dosing and gamma scintigraphy correlation to improve site-specific drug delivery precision.
As pipelines expand into peptides, oligonucleotides, mAbs, and ADCs, formulation challenges intensify. Stability, multi-step compounding, tight in-process controls, and analytical complexity require early-stage planning. Lyophilization is critical here, playing a central role in stabilizing sensitive biomolecules.
Piramal recently invested approximately $90 million to expand sterile manufacturing at its site in Lexington, Kentucky. The expansion includes commercial-scale lyophilizers, an isolator-based high-speed filling line, and equipment supporting lipid-based complex modalities such as lipid nanoparticles and nano-emulsions.
By combining QbD-driven development, Stage Gate governance across US, UK, and India sites, and cross-site tech transfer support, Piramal ensures consistency, regulatory alignment, and efficient time-to-market.
Piramal supports orphan and niche drug programs by offering rapid development and small-batch clinical manufacturing at its Ahmedabad PPDS site and seamless tech transfers of programs to commercial facilities within its global network.
Continuous dry granulation, roller compaction, containment-aligned equipment design, and scalable encapsulation technologies support high potency OSD programs.
By developing lyophilized formulations early, investing in specialized sterile manufacturing infrastructure, and applying QbD-driven scale-up strategies.
