Choosing the right partner for your analytical and biosafety testing is critical in the race to approval. Our BioReliance® testing services offer exceptional, risk-mitigating solutions with technical and regulatory expertise, to help you bring life-changing drugs to market. Our testing and manufacturing services span the product cycle from early pre-clinical development to licensed production. Partner with us to meet your needs for biologics safety testing, analytical development, and biomanufacturing services. See our full suite of capabilities.
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The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the US and Canada
An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
NGS-based methods for agnostic broad range detection are suitable options to augment or replace current virus testing methodology. Explore a NGS AAT method for cell line characterization and more.
Learn about our transition to closed processes for expansion of suspension CHO and Sf9 cells and how the closed system compares to traditional processing.
Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.
Learn more about the analytical development for mAbs and recombinant proteins
Review currently available literature and our recommended COVID-19 virus detection test methods and susceptibility of common biological host cells to infection.
Review key methods which are applied to ensure safety of such recombinant proteins, with a focus on alternate and superior methods to the standard transmission electron microscopy (TEM) method.
This paper discusses the regulatory expectations for incorporation of alternative methods with a focus on comparability and strategies for easier substitution of current methods.
A review of studies which involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step and measuring the remaining virus.
Did you know about the alternative rapid method for in vivo MAP/HAP/RAP testing? Download our tech note Blazar® Platform: Rodent Virus Panel From The BioReliance® Portfolio to learn more about our novel degenerate PCR assay designed for the detection of a broad range of adventitious agents.
The Blazar Rodent Panel allows biopharma to move away from traditional in vivo antibody production assays when characterizing cell banks of rodent origin used in the production of biologicals.
By amplifying multiple targets within a conserved region of the viral family genome, Blazar detects a much broader range of adventitious viruses as compared to traditional polymerase chain reaction methods.
Combatting the challenges of developing and manufacturing antibody-drug conjugates (ADCs) requires robust product characterization throughout all phases of development.
Because characterization and comparison of originator and biosimilar candidate mAbs is challenging due to their complex and variable structures, a range of analytical techniques should be employed.
The relationship between physicochemical profile and biological activity — and how this relationship affects clinical performance — is key to informed decisions, accelerated development, and risk reduction.
What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, its behavior, and what effect it has on the patient.
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BLAZAR™ PLATFORM: ACCELERATES VIRAL DETECTION FROM WEEKS TO DAYS
- Accelerate Viral Detection
- Alternatives To In Vivo Assays For Biosafety Testing Of Biologics
- Rapid Biosafety Testing Enables The Future Of Manufacturing
- Blazar Platform: Rodent Virus Panel
- The Blazar® Platform In A Minute
- Accelerate CHO Cell Characterization With The Blazar® Rodent Panel
- Blazar® Platform: Rodent Virus Panel From The BioReliance® Portfolio
- Roadmap To Success: Viral Clearance Services
- Expert Partnership Contract Testing Services
- Analytical Development & Characterization For AAV
- Reveal Your Biologic’s Attributes Earlier And Faster With Expert Guidance
- Closed Processing Cell Bank Manufacturing Services
- NGS Applied To Biologic Production And Safety
- BioReliance® Cell Banking And Storage
- MilliporeSigma’s BioReliance Testing Services Specification Sheet
- Product Characterization Assay Package - Interlot And Biosimilar Comparability
- Product Characterization Assay Package - Cell Line Development
- Product Characterization Assay Package - Impurities
- Product Characterization Assay Package - Lot Release And Stability Testing