:quality(80))
For more than 10 years, Octapharma has been supporting industrial customers worldwide. We offer regulatory, technical and quality assistance with pharmaceutical grade quality products (USP, EP, FDA, EMA, GMP).
Our focus segments include gene and cell therapy, T-cell therapy, stem cell therapy, vaccines, in vitro fertilization, drug formulation (including Botulinum toxin), drug carrier, medical imaging and chemical manufacturing.
Human Serum Albumin
Human Albumin is widely used as an excipient in drug formulation, as a component of cell culture media, for drug delivery, cryopreservation of cells, vaccine manufacturing, or coating of medical devices; ultimately making it a versatile agent in pharmaceutical and biotechnological products.1-3
In addition to Albumin’s use as a stabilizer in liquid and lyophilized protein solutions, it has long been used in both research and commercial settings as a component of growth media and tissue culture.1,4
The usefulness of Albumin as a component of media is that it is incorporated into cell culture in conjunction with growth factors and other peptides. In addition, Albumin can bind to the outer surface of the cell membrane through non-specific adsorption, thereby providing cell protection. This role is particularly evident in bioreactors, where Albumin prevents physical damage to cells caused by hydrodynamic stress.
Albumin is also used successfully as a stabilizer in a variety of vaccines5, including vaccines against rabies, TBE and measles, mumps and rubella.
Description | NDC code (US) | Article number (Europe and ROW) |
|---|---|---|
ALBUMIN 5% 100ML | 68982-0623-01 | 5400939 |
ALBUMIN 5% 250ML | 68982-0623-02 | 5400956 |
ALBUMIN 5% 500ML | 68982-0623-03 | 5400971 |
ALBUMIN 20% 50ML | 68982-0633-01 | 5400933 |
ALBUMIN 20% 100ML | 68982-0633-02 | 5400949 |
ALBUMIN 25% 50ML | 68982-0643-01 | 5401000 |
ALBUMIN 25% 100ML | 68982-0643-02 | 5400963 |
Virus Inactivated Plasma
Both in industry and in research, human plasma is used as a supplement to cell culture media and as a component of bioassays, immunoassays or enzyme assays.
Replacing the commonly used fetal calf serum (FCS) with human plasma, in combination with platelet lysate, supports the growth and proliferation of for example mesenchymal stromal cells (MSCs).
Autologous MSCs can potentially be used to replace tissue defects, but the procedure carries risks such as immunization and xenogeneic infection. The absence of animal components in the medium can reduce some of these risks6.
Description | NDC code (US) | Article number (Europe and ROW) |
|---|---|---|
PLASMA AB | 68982-0954-01 | 5200461 |
PLASMA A | 68982-0952-01 | 5200493 |
PLASMA B | 68982-0953-01 | 5200494 |
PLASMA O | 68982-0955-01 | 5200495 |
Human Antithrombin III Concentrate
In order to minimize thrombogenicity, antithrombin III is used as an additive in the production of protein solutions such as prothrombin complex concentrates due to its anticoagulant properties.7
Description | Article number (outside the US) |
|---|---|
ANTITHROMBIN III 500IU | 5700193 |
ANTITHROMBIN III 1000IU | 5700183 |
Human Fibrinogen Concentrate
During blood coagulation, fibrinogen (coagulation factor I) is converted into fibrin by the serine protease thrombin (coagulation factor IIa).
Fibrinogen has various applications in pharmaceutical and biotechnological manufacturing. It can be used as a coating on medical devices, and in wound healing. Combined with thrombin, Fibrinogen can be applied to a collagen patch for use as a topical hemostatic agent. These two agents are used to induce rapid hemostasis and tissue sealing following a variety of indications including thoracic, plastic, pediatric, hepatic and minimally invasive surgery.8
Description | NDC code (US) | Article number (Europe and ROW) |
|---|---|---|
FIBRINOGEN 20MG/ML 50ML | 68982-0347-01 | 5800087 |
Immunoglobulin
Immunoglobulin is an established remedy for antibody deficiencies and several autoimmune diseases. Immunoglobulins, also known as antibodies, help the immune system fight infections and decrease inflammation in the body.
Description | NDC code (US) | Article number (Europe and ROW) |
|---|---|---|
IVIG 5% 20ML | 68982-0840-01 | 5600943 |
IVIG 5% 50ML | 68982-0840-02 | 5600942 |
IVIG 5% 100ML | 68982-0840-03 | 5601024 |
IVIG 5% 200ML | 68982-0840-04 | 5601027 |
IVIG 10% 20ML | 68982-0850-01 | 5600967 |
IVIG 10% 100ML | 68982-0850-03 | 5601025 |
SCIG 1G/6ML | 68982-0810-01 | 5680131 |
SCIG 2G/12ML | 68982-0810-03 | 5680132 |
SCIG 4G/24ML | 68982-0810-05 | 5680133 |
SCIG 8G/48ML | 68982-0810-06 | 5680134 |
Human AB Serum
Human AB Serum, Converted from octaplas®, Pooled Plasma (Human), Xeno-Free, Virus Inactivated
Human AB Serum, Converted from octaplas®, Pooled Plasma (Human), Xeno-Free, Virus Inactivated is manufactured, tested, and released following relevant cGMP guidelines for ancillary materials and is specifically formulated for cell and gene therapy applications. By leveraging octaplas®, a pharmaceutically licensed virus inactivated and prion-ligand treated plasma, as a raw material, Octapharma and Akron Biotech are now offering a high quality, virus inactivated Human AB Serum product with greater batch-to-batch consistency and a unique safety profile. Raw material donor selection ensures that the product is devoid of antibodies for A and B blood antigens, therefore minimizing immune reactivity in cell culture. This product is manufactured using xeno-free components and is considered a comparable alternative to fetal bovine serum or other animal-based products.
For Use Statement:
For research use or further manufacturing use in ex vivo cell therapy applications. This product is not intended for direct in vivo use or for direct clinical use as a drug, therapeutic, biologic, or medical device.
References
1) Francis GL (2010) Albumin and mammalian cell culture: implications for biotechnology applications. Cytotechnology 62: 1-16
2) Elsadek B, Kratz F (2012) Impact of albumin on drug delivery – new applications on the horizon. J. Control release 157: 4-28
3) Larsen MT et al. (2016) Albumin based drug delivery: harnessing nature to cure disease. Mol Cell Ther 27; 4:3
4) Shahin H et al (2020) Human serum albumin as a clinically accepted cell carrier solution for skin regenerative application. Nature Research Scientific Reports (2020) 10:14486
5) Marth E, Kleinhappl B (2001) Albumin is a necessary stabilizer of TBE-vaccine to avoid fever in children after vaccination Vaccine Nov 12;20 (3-4):532-7
6) Castrén E et al. (2015) Osteogenic differentiation of mesenchymal stromal cells in two-dimensional and three-dimensional cultures without animal serum. Stem Cell Research & Therapy 6:167
7) Brinkman JM (2016) Anticoagulation Therapy, chapter 5. DOI: 10.5772/64304
8) Erdogan D, van Gulik TM (2008) Evolution of fibrinogen-coated collagen patch for use as a topical hemostatic agent J Biomed Mater Res 85B(1):272-8
