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PATH3308 > 4 - Advanced Therapy Medicinal Products (ATMPs) > Flashcards

4 - Advanced Therapy Medicinal Products (ATMPs) Flashcards

1
Q

ATMPs

A
  • Biological medicines for human use that are based on genes, cells or both
  • Some contain GMOs
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2
Q

What is considered a biological therapeutic good

A
  • Cell-based products (including genetically modified and non-minimally manipulated cells)
  • Immunotherapy products containing human cells
  • Combination products (e.g. cell therapy and medical device)
  • Products that comprise or contain live animal cells, tissues or organs (e.g. pancreatic islet cells isolated from pigs)
  • Autologous human cells and tissue products (including stem cells)
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3
Q

Definition of biologicals

A

A thing made from, or that contains, human cells or human tissues, and that is used to treat or prevent disease

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4
Q

Biological medicines

A
  • Recombinant products
  • Plasma derived products
  • Vaccines (that do not contain viable human cells)
  • Gene-therapy vectors alone
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5
Q

ATMPs vs tissue/cell transplantation

A
  • Distinction depending on how the tissue or cells are processed and used clinically
  • ATMPs have been substantially manipulated or not intended for the same essential function in the recipient and the donor.
  • In contrast, tissue or cellular preparations that are not subjected to substantial manipulation and are used for the same essential function are not ATMPs.
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6
Q

Autologous stem cell transplantation process

A
  1. Stem cell mobilisation
  2. Collection of stem cells
  3. Processing
  4. Conditioning and treatment
  5. Reinfusion back into patient
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7
Q

Three examples of blood cancers and type of transplantation used

A
  • Multiple Myeloma (autologous stem cell transplantation)
  • Hodgkin and Non-Hodgkin Lymphoma (autologous stem cell transplantation)
  • Acute Myeloid Leukemia (allogeneic stem cell transplant)
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8
Q

Serum eye drops for dry eye syndrome

A
  • Due to SLE, age, injury etc
  • Resembles tears
  • Composed of water, salts, proteins, lipids, growth factor
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9
Q

Example of autologous gene modified cell therapies

A

Car T cell therapy for cancer patients

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10
Q

CAR T cell therapy process

A
  1. Leukapheresis
  2. T cell activation/transduced with viral vector (chimeric antigen receptor)
  3. Modified T cell expansion
  4. Chemotherapy
  5. Modified T cell infusion
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11
Q

Chimeric antigen receptor (CAR)

A

Specificity of antibody combined with function of T cell

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12
Q

Prevalence of melanoma

A
  • 4th most commonly diagnosed cancer in Australia
  • 11th most common cause of cancer deaths
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13
Q

Why are solid cancers harder to treat than liquid (blood) cancers

A

As cancer cells are not easily approachable by T cells which normally eliminate them

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14
Q

Tumour infiltrating lymphocytes (TILs) for melanoma

A
  • Tumour excision
  • TIL isolation and initial expansion
  • Screen TILs for autologous tumour activity
  • Rapid expansion of selected TILs (and stimulated with IL-2)
  • Reinfusion after host preconditioning
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15
Q

TILS in melanoma

A

Recognise melanoma tumour but because of microenviormmet of tumour TILs are arrested and thus become inactive

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16
Q

Corneal Endothelial Cells (CEC)

A
  • Loss of CEC results in reduction of corneal transparency, causing visual impairment and blindness.
  • Corneal transplant is the current gold standard treatment
  • Donor shortage, need for alternative solutions
17
Q

Mesenchymal Stem Cells (MSCs)

A
  • Bone marrow residents
  • Also found in adipose tissue, umbilical cord, blood, placenta
  • Fibroblast like, adherent cells
  • Ability to differentiate into other cell types
18
Q

MSCs functions

A
  • Form connective tissue scaffolding in bone marrow
  • Form a haemopoiesis niche and supports proliferation and differentiation of HSC by secreting cytokines, chemokines & growth factors
  • Immunosuppressive activity
  • Immunomodulatory mechanisms mediated by direct cell contact with immune cells and paracrine activity
  • Respond to inflammation by homing to affected tissues
  • Support tissue repair
19
Q

Role of TGA

A
  • Evaluates and regulates medicines and medical devices
  • Ensure therapeutic goods supplied in Aus are safe
  • Administers therapeutic goods act
  • Maintains ARTG

PATH3308 (13 decks)

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