Bionique Testing Laboratories
Bionique is a specialized and technical company that tests biological products and raw materials for mycoplasma contamination. They partner with biopharmaceutical clients to provide consultative testing and validation solutions tailored to regulatory needs. Their services include testing cell banks, raw materials, unprocessed bulk harvest, and final drug products across various modalities. Bionique emphasizes high-quality support, technical expertise, and regulatory compliance to ensure product safety and integrity.
Industries
Nr. of Employees
small (1-50)
Bionique Testing Laboratories
Saranac Lake, New York, United States, North America
Services
Contract laboratory testing to support lot release decisions using rapid and compendial mycoplasma detection methods tailored to product and regulatory needs.
Mycoplasma testing of cell banks and cell culture materials using real-time PCR (with broth enrichment), harmonized compendial culture methods, and related qualification assays.
Screening of critical raw materials used in biomanufacturing for mycoplasma contamination to support supply-chain risk mitigation.
Custom assay development for molecular and culture-based mycoplasma detection, phase-appropriate validation, and transfer services to support client implementation and regulatory submissions.
Online submission portals and structured sample handling instructions for PCR-based and growth-based mycoplasma testing workflows.
Contract laboratory testing to support lot release decisions using rapid and compendial mycoplasma detection methods tailored to product and regulatory needs.
Mycoplasma testing of cell banks and cell culture materials using real-time PCR (with broth enrichment), harmonized compendial culture methods, and related qualification assays.
Screening of critical raw materials used in biomanufacturing for mycoplasma contamination to support supply-chain risk mitigation.
Custom assay development for molecular and culture-based mycoplasma detection, phase-appropriate validation, and transfer services to support client implementation and regulatory submissions.
Online submission portals and structured sample handling instructions for PCR-based and growth-based mycoplasma testing workflows.
Expertise Areas
- Mycoplasma testing and assay development
- Rapid microbial methods (RMM) for biologics
- Cell and gene therapy product testing
- Lot release testing and quality control
Key Technologies
- Real-time PCR (with broth enrichment)
- Automated nucleic acid extraction
- Rapid microbial methods (RMM)
- Culture-based isolation methods
News & Updates
The groundbreaking ceremony on May 14, 2024, marks a significant investment in Bionique’s growth, enabling expansion of biosafety testing services.
Lori Daane, PhD, joins Bionique as its new CSO effective April 1, 2024, to lead service portfolio expansion.
Resources to learn more about mycoplasma and its implications in products.
The team received the 2023 Asahi Kasei Bioprocess Division Award for innovation and achievement.
Bionique announced its acquisition by a subsidiary of Asahi Kasei Medical Co., Ltd. on December 15, 2021.
The groundbreaking ceremony held on May 14, 2024, marks a significant investment in Bionique’s continued growth and commitment to progress.
The groundbreaking ceremony on May 14, 2024, marks a significant investment in Bionique’s growth, enabling expansion of biosafety testing services.
Lori Daane, PhD, joins Bionique as its new CSO effective April 1, 2024, to lead service portfolio expansion.
Resources to learn more about mycoplasma and its implications in products.
The team received the 2023 Asahi Kasei Bioprocess Division Award for innovation and achievement.
Bionique announced its acquisition by a subsidiary of Asahi Kasei Medical Co., Ltd. on December 15, 2021.
The groundbreaking ceremony held on May 14, 2024, marks a significant investment in Bionique’s continued growth and commitment to progress.