Formulation Development & Manufacturing · Industry updates
Follow sourced scientific, clinical, partnership, capacity, and financial developments. Factual summaries and business interpretations are presented separately.
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Phillips Medisize announced an investment to acquire the complete footprint of its Chippenham site in England, strengthening its Global Inhalation Center of Excellence alongside Cambridge. Building on the 2025 Vectura acquisition, the site supports drug-device formulation development and early- and late-stage clinical supplies. The announcement links the investment to anticipated growth in complex inhaled therapies.
PharmAla signed an agreement with Corealis Pharma for ALA-002 drug-product development and GMP clinical supply. Corealis has begun formulation work in Laval, Québec, with an initial 50 mg capsule planned. Manufacturing of the first GMP batch is conditional on completing development activities. The agreement establishes a development and supply arrangement, rather than a product approval.
A Frontiers in Chemistry review examines pharmaceutical cocrystals as a way to modify dissolution and related biopharmaceutical properties without changing an API's chemical identity. The abstract distinguishes solubility-limited BCS II drugs from permeability-limited BCS IV drugs. It highlights gastrointestinal instability, manufacturing reproducibility, coformer selection, and limited pharmacokinetic evidence. Much of the reported performance evidence remains preclinical.
BioPharm International reported Shilpa CDMO's plan to invest $50 million in peptide manufacturing at Raichur, India. The phased expansion would add 10 kiloliters of solid-phase synthesis reactor capacity, beginning with a commercial line planned for December 2026. Commercial supply is expected to ramp during 2027; these are planned capabilities rather than demonstrated utilization.
Lonza signed an agreement to acquire five US CDMO sites from Merck KGaA, adding bioconjugation, payload-linker, viral vector, and advanced delivery capabilities. Closing is expected in mid-2027, subject to customary conditions. Until then, the businesses will continue operating independently.
An AAPS Open study used a compaction simulator to track reversible density changes in urea between 600 and 900 MPa, consistent with its known form I-to-III transformation. The original abstract proposes in-die density monitoring as a material-sparing screen for pressure-induced phase changes. Applicability depends on a sufficiently large density difference; urea is the demonstrated model compound.
Samsung Biologics reported that 97.66% of PolyPeptide's issued shares had been tendered by October 30, with a provisional participation rate of 97.99% including concert parties. Its November 2 notice postponed settlement and anticipated completion in late 2026 or the first quarter of 2027, subject to remaining offer conditions and regulatory approvals.
Lonza announced three planned multiproduct bioconjugation suites in Visp, with operations expected from 2028, alongside 500-liter single-use upgrades scheduled for 2027. A November 2 update revised the new facility's maximum scale from 1,200 to 3,000 liters. The capacity remains under development; the announcement does not establish available current commercial slots.
Codis has moved its Haverhill expansion into construction after completing demolition of redundant facilities. The project will add a solvent-capable GEA PSD-4 spray dryer for commercial-scale amorphous solid dispersions and connect with formulation, analytical, clinical supply, and oral solid dose services in Nottingham. Additional capacity is expected in the fourth quarter of 2027, after installation and validation.
MEPSGEN has launched NanoCalibur Mini for automated formulation of lipid and polymeric nanoparticles at volumes of 0.1 to 3 milliliters. The system targets early screening when payloads and excipients are scarce. The company says its platforms retain identical microfluidic mixing geometry across scales and increase throughput through parallelization, an approach intended to reduce process redevelopment during technology transfer.
Biomay introduced a personalized cancer-vaccine manufacturing service, reporting an approximately three-week mRNA workflow from starting material through quality release. The process covers template DNA, transcription, LNP manufacturing, testing, and qualified-person release, supported by in-house analytics and dedicated suites. Biomay cited experience releasing more than 120 personalized GMP batches. Timelines and capacity claims are supplier-reported and require program-specific confirmation.
BioNTech inaugurated its clinical-scale mRNA manufacturing and R&D facility at La Trobe University’s Bundoora campus in Melbourne. Built around modular BioNTainer technology, the site combines drug-substance production, formulation, and aseptic filling, with subsidized access planned for researchers and start-ups. GMP operational readiness is expected in mid-to-late 2027 after successful commissioning; inauguration does not mean GMP operations have already begun.
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