Our Malvern Characterization Facility
High-performance structural and physicochemical analysis for biologics, biosimilars and complex molecules in the United States.
BioPharmaSpec’s Malvern facility is part of our international network of analytical testing labs, offering industry-leading analytical services to support the development, regulatory compliance, and approval of complex biopharmaceuticals.
Whether you are running early-phase research or preparing your molecule to meet regulatory requirements, our US lab provides tailored analytical and characterization support throughout the drug development cycle. Our Malvern team is committed to designing analytical strategies that align with industry standards, ensure drug safety, and propel your project to success.
BioPharmaSpec USA
BioPharmaSpec Inc
18 Spring Mill Drive
Malvern, PA 19355, USA
Tel: +1 610-640-5866
Email: services.usa@biopharmaspec.com
Facility Features:
- Located within one of America’s leading biotech and pharmaceutical hubs
- Seamless collaboration with US clients via local teams and direct access to scientific experts
- Multiple mass spectrometry platforms and instruments (e.g. IMS, ECD, TQA, Q-TOF, MALDI-TOF)
- Comprehensive higher order structure analysis portfolio (e.g. Circular Dichroism, FT-IR, 1D and 2D NMR and RedshiftBio Aurora TX (MMS))
- Full range of structural and physicochemical characterization analysis services, including intact mass analysis, peptide mapping, glycan profiling
Our Expertise:
- State-of-the-art analytical instrumentation: Waters Cyclic, Xevo MRT, Q-TOF, Triple Quad, MALDI-TOF, SEC-MALS, UPLC, FT-IR, CD, SV-AUC
- Supports biopharmaceutical development from early drug discovery through late-stage characterization
- Fast turnaround and direct scientist-to-scientist communication
- Aligned with ICH Q6B, FDA, and USP guidelines
- Extensive experience supporting IND and BLA submissions and method qualification
- Proven track record of delivering reliable results across molecule types and development phases
Core Analytical Services Available in the USA
Supporting the Pharmaceutical Industry Across North America
Our Malvern, PA laboratory enables agile, science-first collaboration with clients throughout the United States, Canada, Central and South America and beyond. From early drug discovery to late-phase regulatory testing, we provide the analytical expertise needed to develop safer, more effective therapies and accelerate time-to-market - all while maintaining the highest level of scientific integrity.
- A knowledgeable team with deep regulatory and analytical knowledge
- Aligned with FDA, USP, and ICH Q6B standards
- Efficient onboarding and direct access to lead scientists
Ready to Advance Your Biologic?
Talk to a BioPharmaSpec scientist today to scope your project and receive a tailored, quality-focused analytical proposal.
Our Expert
Chris Ziegenfuss
Chris is Vice President at BioPharmaSpec Inc. and has extensive experience in the design and implementation of biopharmaceutical characterization studies.
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