Client Spotlight: Spermatica Laboratories

Spermatica Laboratories combines rigorous contract testing with translational R&D to advance biomedical safety and product innovation. Headquartered in Woburn, MA, we deliver independent bioassay solutions, custom assay development, and fully traceable analytical services that empower sponsors to clear regulatory hurdles and substantiate market claims with absolute confidence. We conduct nonclinical studies in compliance with Good Laboratory Practice (21 CFR Part 58) and operate under ISO/IEC 17025:2017 accreditation, delivering sperm survival, cytotoxicity, and reproductive toxicology data that support FDA premarket submissions and technical documentation under the EU Medical Device Regulation (MDR 2017/745). Beyond approval, our lot release testing confirms that every batch meets its specification before it reaches a clinic or consumer, giving manufacturers independent biological data they can rely on for quality decisions, regulatory submissions, and audits.

Delivering Specialized Reproductive Bioassays

Spermatica Laboratories provides the Human Sperm Survival Assay (HSSA) and related sperm motility assays, along with cytotoxicity testing and reproductive toxicology screening. Clients use their testing for raw material and supplier qualification, formulation development, design verification, process and packaging changes, lot-to-lot consistency, stability studies, and complaint or CAPA investigations. Their work supports IVF device and culture media manufacturers, medical device companies, lubricant and specialty chemical producers, pharmaceutical companies, and contract manufacturers.

A Focused Laboratory Operation

Spermatica operates from a single laboratory; beyond testing, their team consults with clients on study design, helping define test conditions, controls, and acceptance criteria before testing begins. This hands-on approach helps ensure each study is built to produce meaningful results from the start.

A Collaborative Partnership with PJLA

Spermatica has found a strong partner in Perry Johnson Laboratory Accreditation (PJLA) as they built their quality system. Their team described the assessment process as thorough and practical, noting that PJLA’s assessors understood the different demands of a specialized bioassay laboratory compared to a high-volume testing lab. Assessor feedback helped sharpen their documentation, method validation, and traceability practices, and the PJLA team has remained responsive to questions between assessments.

The Value of Accreditation

Achieving ISO/IEC 17025:2017 accreditation is essential to Spermatica’s work. Their clients submit Spermatica’s data to regulators and base product decisions on it, so they need assurance that results are technically valid and impartial. Accreditation provides that independent verification even before a client’s first study, while holding the team to the same discipline on every study: controlled methods, calibrated equipment, documented training, and a full record from sample receipt to final report.

What Sets Spermatica Apart

Spermatica Laboratories distinguishes itself through focus. While many testing laboratories treat sperm-based assays as one line item in a broad biocompatibility menu, reproductive bioassays are Spermatica’s core work, giving them deep expertise in the protocol variables that change results, including extraction conditions, contact time, sample acceptance criteria, endpoints, and controls. They also work upstream with quality, R&D, and regulatory teams, designing studies that answer specific questions such as qualifying a new supplier, assessing a sterilization change, or investigating a suspect lot.

Looking Ahead

Spermatica continues to focus on growth and expanded capabilities. Their plans include expanding laboratory capacity in Woburn, broadening their assay portfolio and accreditation scope, and growing their client base among device, media, and materials manufacturers in the U.S. and internationally. Longer term, their goal is to become the recognized leader in reproductive bioassays and cytotoxicity testing.

Mission & Philosophy

Spermatica Laboratories is driven by a clear philosophy: “Bring us the decision, not just the sample.” Every study they perform should answer a defined product or quality question. In answering it, they treat scientific integrity, impartiality, and traceability as non-negotiable.

Company Contact Information

Spermatica Laboratories
Website: www.spermaticalaboratories.com
Headquarters: 25K Olympia Avenue, Suite 600, Woburn, MA 01801
Phone: 1-888-515-4985