LGM Pharma acquires Sannova Analytical to expand cGMP analytical and GLP bioanalytical services

LGM Pharma has acquired Sannova Analytical, expanding LGM Pharma’s U.S.-based analytical services platform with Good Laboratory Practice (GLP) bioanalysis and broader current Good Manufacturing Practice (cGMP) testing capabilities, addressing client demand for bioanalysis, impurity testing, and additional laboratory capacity. Sannova Analytical will retain its name, management team, scientific staff, qualified methods, and existing client contacts.

Acquisition expands LGM Pharma’s U.S. analytical services platform

The acquisition supports LGM Pharma’s strategy to build a U.S.-based analytical services platform alongside its API sourcing business. Sannova adds GLP bioanalysis, including peptide and oligonucleotide testing, as well as genotoxic and nitrosamine impurity testing, extractables and leachables evaluations, and additional elemental impurities testing to LGM Pharma’s existing cGMP analytical services.

“Over the last five years, we’ve built analytical testing into a standalone business, and the two things our clients keep asking for are bioanalysis and more extensive impurity work,” said Prasad Raje, Ph.D., CEO of LGM Pharma.

“Sannova gives us both, along with a U.S.-based team that develops and validates its methods at the center of the Northeast pharmaceutical corridor. This acquisition provides additional capabilities, but it also adds capacity for the growing volume of work our clients are bringing to us.”

Clients gain integrated API sourcing, analytical testing, and bioanalysis

Sannova clients will continue working with the same scientific team, qualified methods, and contacts while gaining access to LGM Pharma’s API sourcing, regulatory intelligence, and market intelligence services.

LGM Pharma clients will gain access to a cGMP analytical laboratory in the Northeast pharmaceutical corridor, GLP bioanalytical services, and analytical testing across the U.S. The combined organization will provide a single partner for API sourcing, release and stability testing of APIs and drug products, and bioanalysis.

These services support manufacturers conducting nitrosamine drug substance-related impurity (NDSRI) risk assessments and biotechnology teams advancing programs from preclinical studies through Phase 4.

GLP bioanalysis supports preclinical and clinical studies

Sannova quantifies drug and metabolite concentrations in biological matrices from preclinical and clinical studies. Its work supports pharmacokinetic, toxicokinetic, bioequivalence, and immunogenicity programs, including anti-drug antibody assays.

The company also supports biologics and cell and gene therapy programs using immunoassay and PCR-based methods. Its Somerset laboratory validates methods in accordance with ICH M10, the international harmonized guideline on bioanalytical method validation and sample analysis. Sannova has completed more than 1,500 GLP studies.

Specialized testing addresses nitrosamines and trace impurities

Sannova adds expertise in nitrosamine impurity testing to the analytical support LGM Pharma provides to cGMP customers. FDA guidance on controlling nitrosamine impurities and acceptable intake limits for NDSRIs establishes thresholds that are too low for routine quality control methods to detect reliably. This creates sustained demand for sensitive and reproducible trace-impurity testing.

Sannova also conducts extractables and leachables evaluations to identify compounds that can migrate into drug products from container closure systems, single-use manufacturing components, and delivery devices.

The company has completed more than 3,500 cGMP analytical studies. Its laboratory is registered with the U.S. Drug Enforcement Administration for Schedule II through Schedule V controlled substances. Sannova operates under both cGMP and GLP and has been inspected by the FDA under each framework, most recently in 2025 with no action indicated.

“Our clients chose Sannova for the people and methods behind their data, and those stay in place,” said Malleswar Kollu, president and CEO of Sannova Analytical. “LGM Pharma’s backing lets us continue investing in our scientists, instruments, capacity, and client services faster than we could independently.”

Meet the combined team at AAPS PharmSci 360

Drug developers, generics manufacturers, and contract manufacturers seeking bioanalytical or analytical services can visit Sannova Analytical or meet the combined team at AAPS PharmSci 360, taking place October 25–28, 2026, in New Orleans. The team will be at Booth 1202.

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