What Is Free Expansion Process

[Paula Shuffleburg]

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Human induced pluripotent stem cells (hiPSCs) are manufactured as advanced therapy medicinal products for tissue replacement applications. With this aim, the feasibility of hiPSC large-scale expansion in existing bioreactor systems under current good manufacturing practices (cGMP) has been tested. Yet, these attempts have lacked a paradigm shift in culture settings and technologies tailored to hiPSCs, which jeopardizes their clinical translation. The best approach for industrial scale-up of high-quality hiPSCs is to design their manufacturing process by following quality-by-design (QbD) principles: a scientific, risk-based framework for process design based on relating product and process attributes to product quality. In this review, we analyzed the hiPSC expansion manufacturing process implementing the QbD approach in the use of bioreactors, stressing the decisive role played by the cell quantity, quality and costs, drawing key QbD concepts directly from the guidelines of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

During the FY 2021 CoC Program Competition, project applicants have the option to expand existing eligible renewal projects by submitting an additional new project application for funds for new eligible activities. An expansion project combines an existing eligible renewal project with up to two new projects that request funding to expand the existing project.

If all the projects meet eligibility and quality threshold requirements and are selected for conditional award, then during the post-award process, the HUD field office will combine the funding in one grant.

This year, project applicants who want to request funding for expansion funds are required to submit one Renewal Project Application for the original project and up to two separate New Project Applications for the expanded portion of the project.

If the new project(s) exceed the amount of funding available under the reallocation or Bonus processes, HUD will reduce the funding request to the available amount, which could affect the activities of the new expanded portion of the project.

The new project would expand the current operations of an existing renewal project by adding units, beds, persons served, or services provided to existing program participants, or by adding additional activities to HMIS and SSO-Coordinated Entry projects.

When naming the project, HUD requests you use at least a portion of the renewal project name and add the word "Expansion" at the end of the name. If there are two new projects, the name could add "Expansion 1" and "Expansion 2."

Each Renewal Project Application has a "Renewal Grant Consolidation or Renewal Grant Expansion" screen where you select "Yes--Stand-Alone Renewal Application in a New Grant Expansion." Question 2 has a Renewal Grant Expansion Table where you will enter information about the existing renewal project and the new project.

The expanded portion of the project must be dedicated to survivors of domestic violence, dating violence, sexual assault, or stalking who qualify under paragraph (4) of the definition of homeless at 24 CFR 578.3.

If the application for the new project is submitted and selected using the reallocation process or with CoC Bonus funds, it will keep its rank number and HUD will continue the review and selection process.

If the application is submitted as a DV Bonus project, meets the criteria of a DV Bonus project, and is selected with DV Bonus funds, HUD will remove the project from the New Project Listing, and each project ranked below it will move up one rank position.

NOTE: If the project application is submitted as a DV Bonus project and does NOT meet the criteria of a DV Bonus project, it will remain in the New Project Listing and be considered for award under the CoC Bonus process.

These resources expand on the information above and provide additional guidance on the expansion project application process, ranking expansion applications, and HUD's review of expansion project applications.

Earlier this year, the NWSL announced the asset selection order for Bay FC and Utah Royals FC ahead of the expansion draft. As a result of that process, Bay FC received the first pick in the expansion draft, which will then alternate between the two clubs through 12 rounds, with each team selecting up to 12 players. Each incumbent team may lose no more than two unprotected players throughout the expansion draft. The full rules and procedures document for the 2024 NWSL Expansion Draft, presented by Ally, is available here.

Some chemical and physical processes occur too rapidly for energy to enter or leave the system as heat, allowing a convenient "adiabatic approximation".[3] For example, the adiabatic flame temperature uses this approximation to calculate the upper limit of flame temperature by assuming combustion loses no heat to its surroundings.

In meteorology, adiabatic expansion and cooling of moist air, which can be triggered by winds flowing up and over a mountain for example, can cause the water vapor pressure to exceed the saturation vapor pressure. Expansion and cooling beyond the saturation vapor pressure is often idealized as a pseudo-adiabatic process whereby excess vapor instantaneously precipitates into water droplets. The change in temperature of an air undergoing pseudo-adiabatic expansion differs from air undergoing adiabatic expansion because latent heat is released by precipitation.[4]

A process without transfer of heat to or from a system, so that Q = 0, is called adiabatic, and such a system is said to be adiabatically isolated.[5][6] The simplifying assumption frequently made is that a process is adiabatic. For example, the compression of a gas within a cylinder of an engine is assumed to occur so rapidly that on the time scale of the compression process, little of the system's energy can be transferred out as heat to the surroundings. Even though the cylinders are not insulated and are quite conductive, that process is idealized to be adiabatic. The same can be said to be true for the expansion process of such a system.

The transfer of energy as work into an adiabatically isolated system can be imagined as being of two idealized extreme kinds. In one such kind, no friction, viscous dissipation, etc., and the work is only pressure-volume work (denoted by P dV). In nature, this ideal kind occurs only approximately because it demands an infinitely slow process and no sources of dissipation.

The other extreme kind of work is isochoric work (dV = 0), for which energy is added as work solely through friction or viscous dissipation within the system. A stirrer that transfers energy to a viscous fluid of an adiabatically isolated system with rigid walls, without phase change, will cause a rise in temperature of the fluid, but that work is not recoverable. Isochoric work is irreversible.[7] The second law of thermodynamics observes that a natural process, of transfer of energy as work, always consists at least of isochoric work and often both of these extreme kinds of work. Every natural process, adiabatic or not, is irreversible, with ΔS > 0, as friction or viscosity are always present to some extent.

The adiabatic compression of a gas causes a rise in temperature of the gas. Adiabatic expansion against pressure, or a spring, causes a drop in temperature. In contrast, free expansion is an isothermal process for an ideal gas.

Adiabatic compression occurs when the pressure of a gas is increased by work done on it by its surroundings, e.g., a piston compressing a gas contained within a cylinder and raising the temperature where in many practical situations heat conduction through walls can be slow compared with the compression time. This finds practical application in diesel engines which rely on the lack of heat dissipation during the compression stroke to elevate the fuel vapor temperature sufficiently to ignite it.

Adiabatic compression occurs in the Earth's atmosphere when an air mass descends, for example, in a Katabatic wind, Foehn wind, or Chinook wind flowing downhill over a mountain range. When a parcel of air descends, the pressure on the parcel increases. Because of this increase in pressure, the parcel's volume decreases and its temperature increases as work is done on the parcel of air, thus increasing its internal energy, which manifests itself by a rise in the temperature of that mass of air. The parcel of air can only slowly dissipate the energy by conduction or radiation (heat), and to a first approximation it can be considered adiabatically isolated and the process an adiabatic process.

Adiabatic expansion occurs when the pressure on an adiabatically isolated system is decreased, allowing it to expand in size, thus causing it to do work on its surroundings. When the pressure applied on a parcel of gas is reduced, the gas in the parcel is allowed to expand; as the volume increases, the temperature falls as its internal energy decreases. Adiabatic expansion occurs in the Earth's atmosphere with orographic lifting and lee waves, and this can form pilei or lenticular clouds.

Adiabatic expansion does not have to involve a fluid. One technique used to reach very low temperatures (thousandths and even millionths of a degree above absolute zero) is via adiabatic demagnetisation, where the change in magnetic field on a magnetic material is used to provide adiabatic expansion. Also, the contents of an expanding universe can be described (to first order) as an adiabatically expanding fluid. (See heat death of the universe.)

In the Earth's convecting mantle (the asthenosphere) beneath the lithosphere, the mantle temperature is approximately an adiabat. The slight decrease in temperature with shallowing depth is due to the decrease in pressure the shallower the material is in the Earth.[10]

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