BioSpectra is a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including actives, excipients, GMP process chemicals, and bulk GMP buffers and solutions. Our focus is small molecule synthesis and true, phase-change multi-step purification for both traditional and biopharmaceutical applications.  

Our services include contract GMP product development, coupled with ongoing commercial manufacturing and regulatory support, up to and including DMF submissions. All of our manufacturing processes are fully validated. 

Our U.S.-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Onsite analytical testing capabilities include multi-compendial and custom specifications, with full traceability and transparency of all raw materials and sources. 

Our commitment to quality, compliance and true, U.S.-GMP manufacturing, testing, and regulatory support is unparalleled. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have.    

GMP Product Categories:
     •  Bulk GMP biological buffers
     •	 Active & functional excipients
     •  GMP process chemicals and bulk GMP Solutions
             
Custom GMP Services:
     •  Purification of key ingredients
     •  Full GMP product development
     •  Small molecule custom synthesis
     •  API development and manufacturing
     •  Custom GMP compounded solvents and solutions

Comprehensive Quality and Regulatory Program:
     •  FDA registered and inspected
     •  Document support (DMF submissions)
     •  Global GMP requirements (US, IPEC, ICH-Q7)

Chemicals

Pharmaceutical

Biotechnology

BioSpectra, Inc.

Richard Mutchler

Dana Myles

Tony Keller

Bruce Messinger

Carrie Walsh

Taryn Mowrer M.ed

Katrina Klinger

Britney McFall

Wayne Talamonti

James Piper

Matt Rifenburg

Karen Cramer

Crystal Rose Hamelburg

Greg Fariss

The Operations and Technical Support team at BioSpectra, Inc. plays a crucial role in ensuring the efficient and compliant manufacturing of pharmaceutical-grade ingredients. This team is responsible for overseeing the daily operations of production, addressing technical challenges, and maintaining equipment reliability. They also manage validation processes, support process development, and ensure rigorous training for staff to uphold quality standards, ultimately ensuring that all products meet GMP regulations and customer specifications.

Operations and Technical Support

Quality Assurance and Control

Laboratory and Compliance Team

Operations and Technical Support

About

Team members

Other teams at BioSpectra, Inc.

Quality Assurance and Control

Laboratory and Compliance Team