Insights - blog : Resilience

Alachua Campus Tour Video

Written by Resilience | June 5, 2024

 

With a sustainable network of high-tech, end-to-end manufacturing facilities across North America, Resilience has become a powerhouse in how medicines are made, funded, and scaled. Our Alachua, Florida campus is home to Resilience’s development, manufacturing, and process characterization center for biologics and vaccines.

In partnership with the Department of Defense, Resilience manages the DOD Advanced Development and Manufacturing (ADM) facility in Alachua as a Resilience-owned, Resilience-operated end-to-end biomanufacturing facility. Our model rapidly adapts to business needs to ensure we have the capacity and expertise to pivot and meet emerging customer requirements. 

Below is a transcript of the video. Interested in meeting with our team to discuss how we can support your needs? Connect with us today!

At the heart of our Alachua campus tour is Resilience’s 43,000 square foot Process and Analytical Development Lab. Featuring Upstream and Downstream capabilities geared towards the potential usage of larger bioreactors, this facility pairs with the scalability of our manufacturing spaces for a seamless transition through product maturation.

Our analytical development capabilities feature a mix of traditional and modern techniques, as well as technological advances that put Resilience at the forefront of manufacturing and development. Our tech transfer can integrate with other Resilience sites depending on needs and scale. Our process is highly collaborative, with a focus on open communication with clients.

We have experience and currently work with a variety of Mammalian, Microbial, and Insect cell lines. In addition, we have our proprietary Vero Cell line yielding exciting new possibilities for viral vaccine production. Our capabilities and capacity offerings across established and emerging modalities means you can depend on our expertise and process efficiencies to reach patients faster.

Moving to our Advanced Development and Manufacturing facility. This area provides 21,000 sq ft of GMP space, with negative pressure cascades, HEPA supply and return, ClO2 decontamination ports, spillage containment epoxy floors, and sealed penetrations. Featuring an open ballroom concept, the space allows flexible and agile manufacturing with unidirectional flow.

The space has four independent processing rooms allowing up to four products concurrently. Manufacturing platforms include inoculum prep, cell culture processing, large scale cell processing, fermentation processing and downstream/purification.

The Advanced Development and Manufacturing facility also boasts a full shipping and receiving loading dock and warehouse with cold storage capacity and ultra cold storage for highly sensitive components and products.

For additional scale and capacity in manufacturing, our newest addition to the Alachua site is 92,000 square feet of drug substance and drug product manufacturing space with single-use technology in place.

This space is supplied with dedicated utility systems and equipment in the production and support rooms, designed to meet particulate cleanliness levels at EU grades A, B, C, or D. An automation system maximizes operational reliability of critical services while alarm management systems keep an eye on all critical facility and utility parameters.

Like the Advanced Development and Manufacturing facility, these manufacturing suites allow for concurrent manufacturing of multiple bulk drug substance and drug product biologics and vaccines using various production methods. These include cell bank expansion, production culture, and purification of target products such as recombinant proteins, plasmid DNA, VLPs, monoclonal antibodies and antibody derivatives.

Our four cGMP Drug Substance Production suites feature both upstream and downstream production equipment.

Each room accommodates 500L and 2000L single-use bioreactor trains, with associated harvest and purification capabilities. Six staging spots with all necessary utility drops required for drug substance processing complement the rooms, with Inoculation rooms adjacent to each suite.

The drug product formulation and filling suites provide automated filling capabilities using isolators. These Cytiva SA 25 systems are dedicated for aseptic filling of vials or syringes.

Resilience knows that biomanufacturing supply chains that can withstand disruptive shocks and scale safely are vital to health security, and these facilities in Alachua are designed with agility and risk mitigation in mind to help provide a seamless supply chain.

Have a question for our team? Connect with us today!