GMP Manufacturing

Paragon is capable of taking a client from construction of an expression vector, to performing process development (both upstream and downstream) and into GMP manufacturing of biologics specifically for Phase I/II clinical trials. Thoughtful selection of the company’s staff, equipment, utilities, and facilities expressly for small batch manufacturing is intended to minimize overhead and thereby maximize a client’s return on investment.

GMP Manufacturing of Biopharmaceuticals

Small batch versatility, superior quality and ROI are the defining features of Paragon’s GMP manufacturing service. Backed by years of success with protein expression and purification and an unparalleled team of scientists, Paragon is the logical choice for your GMP biologics manufacturing for:

Phase I/II clinical trials
Diagnostic reagents
Research reagents

Paragon offers:

State-of-the-art Process Development Laboratory
Validated Facilities
Necessary Capacity for Phase I/II production quantities
Quality Tech Transfer
Multiple Expression Systems
Cell Banking
Regulatory Compliance

Facilities

Paragon’s facilities are designed and built specifically for small-batch production of proteins monoclonal antibodies, recombinant vaccines, and virus-like particles under cGMP regulations, suitable for Phase I/II clinical trials, diagnostics or research purposes.

Segregated suites for mammalian, baculovirus or microbial production and purification:

Upstream suites are classified as ISO 8 with single pass, positive pressure class 100,000 HEPA filtered air
Downstream suites are classified as ISO 7 with single pass, positive pressure class 10,000 HEPA filtered air

Prevention of cross-contamination:

Unidirectional flow of personnel and materials
Entry and exit airlocks
Single-use disposables
The suites are monitored by a 24/7 security system and HVAC monitoring system
Environmental monitoring program ensures the suites are cleaned and maintained to cGMP specifications

Capacity

Paragon maintains segregated suites and disposable technology for microbial and mammalian / insect cell manufacturing, each with an ISO Class 8 manufacturing and an ISO class 7 purification room.

Microbial Fermentation Suites – 2x240L working volume Fermentor Train
Cell Culture Suites – 20/50L WAVE; 2x200L SUB, 500L SUB
Virus Suites – 50L SUB

Tech Transfer

Technology transfer is facilitated via our internal process development group working directly with the client. One team, with years of experience working together across multiple GMP-compliant projects, ensures consistency throughout the entire process.

Expression Systems

The Paragon team will work with you to optimize and implement the right expression system for your biologic product.

Mammalian

Transient / Stable transfectants
CHO, HEK 293, Vero, CAP

Microbial

E. coli
Yeast
P. pastoris
S. cerevisiae

Insect

Sf9, Sf21, T ni

Viruses and VLPs

Adenovirus
Adeno-associated virus
Lentivirus
Influenza

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