PYRAMID Laboratories Celebrates 28th Anniversary; Expands Capabilities

PYRAMID Laboratories, Inc. a premier clinical and commercial contract aseptic drug product developer and manufacturer is proud to announce it is celebrating 28 years of providing cGMP services to the Pharmaceutical and Biotech industries during July 2016.

“I am very proud of the high-quality services we have provided the past 28 years and wish to thank our employees and clients for making it possible,” said PYRAMID’s President & CEO, Medhat Gorgy. “PYRAMID has grown tremendously since our modest beginnings in 1988 to having over 70,000 sq ft of GMP facilities with state-of-the-art equipment today.”

PYRAMID recently announced the FDA conducted a Pre-Approval and cGMP Inspection at PYRAMID’s facilities. PYRAMID Laboratories, Inc. is pleased to announce that the FDA did not issue a Form 483.

PYRAMID was found to be in compliance with cGMP’s and has a documentation program that allowed the investigators to easily track, review, and assess all aspects of its quality systems. The inspection evaluated various regulatory submissions, operational processes and procedures regarding the utilities, manufacturing process, media fills, batch records, equipment validation, training records, material handling, data review, reporting and records management systems. The investigator also confirmed the compliances of its responses to observations from the previous inspection. All of PYRAMID’s systems were found to be compliant and satisfactory with all cGMP requirements.

PYRAMID also announced it has expanded its portfolio of services with the addition of a new state-of-the-art Warehouse, Storage, and Distribution Facility. The new facility includes cGMP labeling, approximately 27,600 cubic feet of monitored and alarmed validated controlled temperature storage, and distribution service capabilities for parenteral drug products. PYRAMID’s Warehouse, Storage, and Distribution Center is located adjacent to PYRAMID’s clinical and commercial manufacturing sites that include aseptic fill/finish for vials and syringes in addition to lyophilization services. PYRAMID also provides full-service formulation and process development as well as analytical support for all phases of drug development and manufacturing.

PYRAMID Laboratories, Inc. is an independent professional service organization specializing in contract aseptic manufacturing, product development, formulation development, fill/finish, lyophilization, and analytical laboratory services. PYRAMID provides ICH stability testing and storage compliant with GLP and cGMP guidelines plus controlled temperature storage and distribution services. PYRAMID’s manufacturing services include formulation development, process development, filling and lyophilization for vials in addition to syringe filling applications. PYRAMID has extensive experience working with proteins, peptides, and oligonucleotides in addition to small molecules. PYRAMID serves the pharmaceutical, biotechnology, and medical device industries. For more information, visit www.pyramidlabs.com.