LGM Pharma has acquired Sannova Analytical, adding specialized bioanalytical testing and impurity analysis capabilities to its U.S. laboratory services business. The acquisition broadens LGM Pharma’s contract analytical testing portfolio with Good Laboratory Practice (GLP) bioanalysis, including peptide and oligonucleotide testing, as well as genotoxic impurity analysis, nitrosamine testing, extractables and leachables evaluations, and additional elemental impurity services. Sannova will retain its name and continue operating under its existing management team.

The deal supports LGM Pharma’s strategy to build a U.S.-based analytical services platform alongside its active pharmaceutical ingredient (API) sourcing business. The company said the expanded offering will help pharmaceutical and biotechnology customers access a wider range of development and testing services through a single provider.

“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,” says Prasad Raje, PhD, CEO of LGM Pharma. He adds that Sannova brings specialized capabilities and additional laboratory capacity to support growing demand.

Sannova’s bioanalytical services include measuring drug and metabolite concentrations in biological samples from preclinical and clinical studies. These analyses support pharmacokinetic, toxicokinetic, bioequivalence, and immunogenicity programs, including anti-drug antibody testing. The laboratory also supports biologics and cell and gene therapy development through immunoassay and polymerase chain reaction (PCR)-based methods. Its bioanalytical methods are validated in accordance with the International Council for Harmonization’s ICH M10 guideline for bioanalytical method validation and study sample analysis. Sannova reports having completed more than 1,500 GLP studies.

The acquisition also strengthens LGM Pharma’s ability to support manufacturers addressing nitrosamine impurities, which can require highly sensitive analytical methods to assess and control at trace levels. Regulatory expectations around nitrosamine impurities, including nitrosamine drug substance-related impurities (NDSRIs), have increased demand for testing methods capable of reliably measuring very low concentrations.

Sannova additionally provides extractables and leachables testing to evaluate compounds that may migrate into drug products from packaging, container closure systems, single-use manufacturing components, and drug delivery devices. The laboratory has completed more than 3,500 cGMP analytical studies and is registered with the U.S. Drug Enforcement Administration to handle Schedule II through V controlled substances.

For existing customers, the transition is intended to preserve continuity in laboratory operations. Sannova clients will continue working with their established scientific teams, qualified methods, and existing contacts, while gaining access to LGM Pharma’s API sourcing capabilities and regulatory and market intelligence services. LGM Pharma customers, meanwhile, will gain access to Sannova’s Northeast U.S. laboratory and expanded bioanalytical services.

Malleswar Kollu, president and CEO of Sannova Analytical, says the acquisition would allow the laboratory to maintain its existing customer relationships while increasing investment in personnel, instrumentation, capacity, and client services.

Tom Formolo, a partner at New Harbor Capital, which supports LGM Pharma, says Sannova’s specialized testing capabilities and regulatory track record complement the company’s existing business.

The combined portfolio is intended to support customers across multiple stages of pharmaceutical development, from API sourcing and release and stability testing to preclinical bioanalysis and later-stage development programs. This includes manufacturers assessing impurity risks and biotechnology companies advancing candidates through clinical development.

For more information, visit www.LGMPharma.com.