Omniplasma

Omniplasma is a pooled, SD treated and prion-reduced plasma.

Omniplasma has been added to the product assortment on the advice of the Medical Advisory Board (MAR). Important considerations in this respect included the reduction of the risk of transmission of blood transmissible agents such as viruses and prions, and the further reduction of allergic reactions and the number of TRALI cases.  

In this way, Prothya is satisfying the wishes of its customers. On the basis of the MAR’s considerations, Prothya decided to introduce Omniplasma as the preferred plasma for transfusions. In addition, the Q-plasma will remain available for certain symptoms.

A table has been drawn up to illustrate the differences between the two.

Omniplasma is a pooled plasma, the indications are the same as those for Q-plasma. Omniplasma is a medicine and detailed information in respect of the indications, contraindications, warnings, storage and shelf-life are included in the specification of the product characteristics. When only a small volume is required, for example in the case of young children, you can also make use of the split Q-plasma units. Q-plasma is used for exchange transfusions.

Omniplasma is a pooled product and has also undergone an industrial treatment process. On that basis, it qualifies as a medicine.

ESDEP was supplied in the period 1996-2002. This was a pooled SD-treated plasma. There was no prion reduction step in this process. At the time, the absence of a prion reduction step was the reason given for stopping the distribution of this product.

Octaplas is a pooled SD-treated plasma, the plasma comes from paid and unpaid donors who live abroad.

Octaplas LG is a pooled SD-treated plasma that has undergone a prion reduction step, the plasma comes from paid and unpaid donors who live abroad.

Omniplasma undergoes the same production process as Octaplas LG, except that in its case the plasma comes from voluntary and unpaid donors living in the Netherlands.

During the production process of Octaplas LG and Omniplasma, the duration of the SD-treatment is shorter, this has a favourable effect on the protein S and alpha2-antiplasmin which are labile to SD chemicals. The shortened SD-treatment does not lead to any reduction in viral safety.

There is only a limited quantity of quarantine plasma available for specific applications, for example paediatric administration, exchange transfusions for neonates and lgA-deficient patients.

Each donor is screened, just as is applicable for the Q plasma supplied by Sanquin Blood Bank. In addition, NAT-tests are carried out for hepatitis A and Parvovirus B19. In the case of Parvovirus B19, the NAT-test does not have to be negative, but a value has been set for the permitted content of Parvovirus B19 DNA. Prior to production, the production pool is tested for Parvovirus B19, ultimately these pools may contain no more than 10 IU/µl Parvovirus B19 DNA.

An SD treatment is applied during the Omniplasma preparation process. This treatment is effective and makes the lipid enveloped viruses, for example HIV, HCV, HBV, inactive (West Nile virus also belongs to these types of viruses).

Neutralised antibodies against HAV and Parvovirus B19 are also present as pooled products.

The same exclusion criteria apply to Omniplasma as those for donors when it relates to a stay in the United Kingdom, use of growth hormones, cornea and cerebral membrane transplants, family members with Creutzfeld-Jacob disease. Additionally, in the Omniplasma preparation process, an affinity chromatography step is performed with a prion-specific ligand.

The policy regarding travel to countries where there is malaria remains the same for Omniplasma. In addition, a sterile filtration (0.45 µm and 0.2 µm) is used as filling in the Omniplasma preparation process.

Yes, that is possible. Prothya has focused its way of working on supplying clinical chemical laboratories. To this end, an agreement between a hospital pharmacist and a clinical chemical laboratory is required. The hospital can draw this up itself or make use of an existing format. The text in this format cannot be changed. As Omniplasma is a medicine, the hospital pharmacist remains responsible. 

A frozen product is fragile. By carefully packaging and delivering Omniplasma in an outer box (containing 10 units), the chance of breakage is reduced.

Outer box: 

26 x 15.5 x 20 cm

Single package:  

15 x 13 x 3 cm

The labelling of the Omniplasma units meets the requirements of the Medicines Act (Geneesmiddelenwet) and (in respect of bar coding) meets the requirements of ISBT 128.

Compared to the structure of the labels that Sanquin Blood Bank uses for short-life blood products, there are therefore a few differences, both in the layout and in the content of the bar codes. It is important that the software is designed for this, both for your laboratory system and product scanners.

Coding of the units

Below is an example of the label for a unit of fresh, frozen (quarantine) plasma.

This label has six (6) bar codes, namely (from left to right and from top to bottom):

1. The EIN (donation number);
2. The blood group code;
3. The collection date;
4. The product code;
5. The expiry date;
6. The extra feature.

Below is an example of an Omniplasma label. This label has five (5) bar codes. The content is, from left to right and from top to bottom: (numbering in accordance with the Quarantine plasma label).

1. EIN (unit number)
2. The blood group code; this is encrypted: (blood group ABO) (Rhesus unknown) because Omniplasma has no RhD
3. The product code
4. The expiry date
5. The medicine code

The differences and similarities are as follows:

Coding of the boxes

Prothya supplies Omniplasma to hospitals in outer boxes of 10 pieces. Each box has a box label that states:

• The EINs of the 10 units in the box
• The box number
• There is a label on the box which corresponds to the units in the box; this displays the data of the batch in an ISBT 128 bar code (blood group, batch number, expiry date).

This data is provided on the box for convenience and traceability, the information about the units in the box can be scanned and read without the box having to be opened. The units in the box can be quickly added to the stock, and the box as a whole can be kept in stock.

Since 1 January 2014, the healthcare validity code (zorgactiviteitcode) 190470 has been valid specifically for Omniplasma. Until that time, it was best to use 190404, so that it was clear that it related to plasma (that was not 190489, which was the residual group).

Contact details

The Unit of Transfusion Medicine (UTG) is part of Sanquin Blood Bank and provides advice to doctors, pharmacists, medical specialists and clinical chemists. Professionals can consult doctors from the UTG by telephone 24 hours a day, 7 days a week.

If you have any questions or comments about the labelling, please contact info@prothya.com.

Omniplasma has a shelf-life of four (4) years after being produced. 

How long can Omniplasma be stored once it is thawed?

The SPC stipulates that after thawing, Omniplasma can be stored for five (5) days at +2 to +8°C and eight (8) hours at room temperature (+ 20 tot + 25°C). Medicines must be used in accordance with the SPC.

Recently, a number of articles have been published about the thawed status of Octaplas LG (same process, different plasma source) and the effect on the coagulation factors.

Keller et al. Transfusion and Apheresis Science 46 (2012) 129–136 [link]

Keller et al. Blood Transfus 2012; 10: 360-7 [link]

A. Neisser-Svae et al. Transfusion 2016; 56; 404-409 [link]

Omniplasma can be ordered from Sanquin Blood Bank, where the short-life blood products are also ordered. The product can be delivered to a clinical chemical laboratory, provided there is an agreement between the hospital pharmacy and the clinical chemical laboratory. 

In contrast to the short-life blood products, Omniplasma has an individual product code per blood group.

The table below provides an overview of the codes and descriptions:

Z-index nummers Omniplasma

15835111        omniplasma infvlst bloedgroep      0 bag 200ml

15835073        omniplasma infvlst bloedgroep      a bag 200ml

15835081        omniplasma infvlst bloedgroep      a+b bag 200ml

15835103        omniplasma infvlst bloedgroep      b bag 200ml

Urgent delivery is possible. The smallest quantity that can be ordered is a box of ten pieces. Due to the longer shelf-life of Omniplasma, the risk that a product must be destroyed is low.

The price of Omniplasma is stipulated in the Prothya price list. Because Omniplasma is a medicine, VAT must be levied. The low rate of VAT is applicable for medicines.

Omniplasma deliveries are invoiced once a month. You will receive a separate invoice for Omniplasma, even if the delivery takes place simultaneously with other products (erythrocytes, or plasma products for example).

The Transfusion Medicine Unit (UTG) is part of Sanquin Blood Bank and provides medical advice to doctors, pharmacists, medical specialists and clinical chemists. Professionals can consult doctors from the UTG by telephone 24 hours a day, 7 days a week.

Please contact UTG.

Omniplasma is classified by law as a drug, therefore, it has to be reported to Prothya or Lareb.

These are listed in the SPC:

• IgA deficiency with documented antibodies against IgA.
• Hypersensitivity to the active ingredient, and to any of the excipients or residues from the manufacturing process.
• Serious protein S- deficiency.

In a number of these situations, it is possible to switch to Q-plasma. In case of IgA deficiency, Sanquin has special plasma available from IgA-deficient donors.

Just as the plasmin inhibitor alpha2-antiplasmin, Protein S is labile for the SD chemicals used. Therefore, the SD treatment has an effect on the concentration of these proteins. By adapting the duration of the SD treatment in the Omniplasma production process, the values of these two proteins have improved considerably compared to those of Octaplas in the past.

Omniplasma can be used in the treatment of TTP. The indication is included in the SPC. In addition, there is literature about the composition of the product specifically for ADAMTS13 concentration and activity as well as factor H for the treatment of atypical HUS.

Edel et al. Efficacy and Safety Profile of Solvent/Detergent Plasma in the Treatment of Acute Thrombotic Thrombocytopenic Purpura: A Single-Center Experience.  Transfus Med Hemother 2010; 37:13–19  

Heger et al. Normal levels of ADAMTS13 and factor H are present in the pharmaceutically licensed plasma for transfusion (Octaplas®) and in the universally applicable plasma (Uniplas) in development. Vox Sanguinis (2007) 92, 206–212 

A unit of Omniplasma contains 200 ml and Q-plasma contains 310 ml. Experience in Finland shows that a 15% increase was witnessed in a number of units. That would mean that generally the number of units suffices. Where dosing is by ml, as with TTP for example, more units will be needed.

Pooling results in a product with a standardised composition, which makes the clinical effect more predictable. In addition, there are also advantages with regard to transfusion reactions:

• TRALI: by pooling both male and female plasma, any HLA and HNA antibodies are diluted and/or neutralised. Hemovigilance databases in other countries have not reported any
• TRALIs when using Octaplas.
• Allergic reactions: allergens are also diluted in the pool. Based on the Austrian hemovigilance database, a reduction of 15.6% has been seen in allergic reactions. N.B. reactions due to anti-IgA can also occur with this product, use should then be made of IgA-deficient Q-plasma.

An overview of relevant documents for Omniplasma (in Dutch):

• Praktische aspecten bij het ontdooien van Omniplasma
• Overeenkomst tussen ziekenhuisapotheker en klinisch chemisch laboratorium
• Toelichting ZAPO-verklaring
• Begeleidend schrijven Omniplasma 16 juli 2014
• Checklist voor implementatie van Omniplasma
• Etikettering Omniplasma
• Traceability en origine van donaties voor Omniplasa

In addition to the general description from the SPC, Prothya provides a number of SOPs that describe the thawing of Omniplasma using different equipment:

• Helmer D4 waterbad
• Plasmatherm
• Sahara III
• Validatiestudie ontdooien

• the product code
• the blood group
• the unit identification number
• the shelf-life
• the 2D matrix on the removable flag label

• There is an additional action: deregistering the unit from the European database. This requires an ICT solution. 
• The lay-out of the label has been changed and the linear codes corresponding to the EIN and the expiry date are no longer in the usual position. This could impact the scan order. 
• It may be necessary to adjust the internal SOPs and to review the existing agreements with pharmacists and hospital pharmacists.

• The 2D matrix is attached to a part of the primary bag’s label. On delivery that bag is frozen and (therefore) not slippery. In addition, the primary bag is sealed in foil.
• Only after thawing are the bag and primary label released. For the purposes of deregistration, the part that contains the 2D matrix is removable.