Tergus Pharma’s Commercial Manufacturing Facility, North Carolina

In July 2019, Tergus Pharma plans to begin constructing a pharmaceutical manufacturing facility and headquarters in Raleigh, North Carolina, US.

The facility will expand the company’s commercial manufacturing capabilities and support it to provide comprehensive solutions, including development and manufacturing services.

Expected to open in early-2020, the facility will expand the company’s current manufacturing by more than 400%.

Tergus Pharma’s commercial manufacturing facility location

Tergus’ manufacturing facility will be located at Research Triangle Park in Durham.

Spanning approximately 1.2 million square feet, the Research Triangle Park is a technology research and science park located close to the Raleigh-Durham international airport.

It is well connected to Raleigh, Chapel Hill, and Cary via the North Carolina Highway 147 and interstates 40.

Details of Tergus Pharma’s commercial manufacturing facility

The state-of-the-art current good manufacturing practice (cGMP) compliant commercial manufacturing facility will occupy 100,000ft² of floor area.

The building will include a commercial manufacturing area, packaging lines, good manufacturing practice (GMP) warehouse, laboratory and office space.

A variety of tanks and lines will be installed in the facility for manufacturing and packaging. High-potent speciality hormone suites will be developed for differentiation.

The facility will also feature clinical trial materials manufacturing space to meet the demand for phase one to phase three clinical trial materials.

Financing

Great Point Partners (GPP), a healthcare investment firm based in the US, will finance the development of the new facility through equity capital.

GPP and Tergus were in discussions for several years for the development of a new commercial manufacturing facility.

Details of Tergus’ existing manufacturing facility in Research Triangle Park

Tergus currently operates a 2,000ft² state-of-the-art good laboratory practice (GLP) and cGMP manufacturing facility in Research Triangle Park in North Carolina.

The facility features cleanrooms designed in compliance with International Standardisation Organisation (ISO) 8 and handles highly potent compounds, including steroids and sexual hormones. It has a highly-equipped laboratory to handle manufacturing in batches of up to 150kg.

Services offered by Tergus

Tergus Pharma provides various services including topical formulation development, in vitro release testing (IVRT), in vitro permeating testing (IVPT), skin biology, analytical services, and clinical trial material supplies.

IVRT, also known as Franz diffusion, is performed to evaluate and support the required manufacturing changes after approval by the US Food and Drug Administration (FDA). The test is performed according to scale-up and post-approval changes (SUPAC) SS requirements.

The Franz diffusion cell is utilised to evaluate the release profile of the semi-solids.

IVPT, also known as skin permeation testing, is used to determine the delivery of a drug in various skin layers to help in selecting the formulation. The company’s repository of more than 120 vertical Franz diffusion cells assists IVRT and IVPT studies.

Tergus also performs early safety screening for skin irritation, sensitisation, ocular irritation, and phototoxicity and develops target engagement models to understand the retinoid activity, UV protection, skin pigmentation or lightening, ex vivo tissue culture, reconstructed and genetically modified human skin.

Marketing commentary on Tergus Pharma

Based in the US, Tergus Pharma is a contract research organisation that develops topical dermatology pharmaceuticals.

The company primarily focusses on semi-solid product development and formulates semi-solid dosage forms such as topical foam, transdermal gels, ointments, lotions, creams, microencapsulation, and nanoemulsions.

Tergus initiated the Quality by Design (QbD) for topical drugs and provides comprehensive services for topical pharmaceutical research, drug development, testing, and commercialisation to develop branded and generic dermatology products.