Plasmaplant | JV Pharmland LLC

Plasmaplant

  • Situated in Nesvizh, Republic of Belarus, constructed in 2015
  • Production capacity is 450 000 liters of plasma per year. Potential increase - 1 000 000 liters per year
  • We produce albumin, immunoglobulin, clotting factors VIII and IX
  • The plant can also produce thrombin, antithrombin III, fibrinogen, von Willebrand factor and others.

PHARMLAND SERVICES:

  • TECHNOLOGY TRANSFER
  • CONTRACT MANUFACTURING

Forms of cooperation

  1. Consultation and assistance in developing local plasma collection centers.
  2. Contract fractionation (toll fractionation) of plasma for derivative medicinal products manufacturing - clotting factors, albumin and immunoglobulin.
  3. Expertise and technology-transfer for development of a local plasma processing plant. The eventual goal is establishing of all production phases, packaging and marketing within the budget constraints. For this phase in particular Pharmland offers end-to-end support that includes plant analysis, design, personnel training, support of authorization and start-up.

 

TECHNOLOGY TRANSFER
Pharmland has skills and expertise respectively to the market of plasma-derived medicinal products which allows us to offer our technological know-how on:

  • manufacturing of a single blood plasma product;
  • production of a whole product range;
  • development or upgrading of production lines or fractionation plants.

In these areas Pharmland can offer:

  • technological know-how;
  • support of engineering companies;
  • staff training and validation;
  • on-the-spot assistance during validation procedures;
  • production follow-up once authorizations have been issued;
  • copies of registration files, including clinical studies and viral validation studies, to be submitted to the authorities concerned to obtain marketing authorizations.

According to the customer’s requirements, such technology transfer can also include:

Plant development:

  1. Plant Layout review:
  • operation rooms (areas classification, pressure flow);
  • personnel flow, material flow (clean flow, dirty flow)
  • process flow diagram
  1. P&IDs review referring to instruments equipment and utilities.

Documentation:

  1. list of raw materials and auxiliary materials;
  2. SOPs regarding QC/QA/production maintenance;
  3. QC instruments list (in-process control & finished product control);
  4. product/process/intermediate specifications;
  5. packaging specifications;
  6. BMR (Batch Manufacturing Records);
  7. VMP;
  8. IQ/OQ/PQ protocols;
  9. QC methods validation;
  10. process consistency protocols:
    upstream process (fractionation & purification);
    downstream process (filling);
  11. cleaning validation protocol (CIP; SIP);
  12. safety data and risk assessment;
  13. finished product/ intermediates stability data;
  14. accelerated stability data (if required);
  15. registration dossier referring to each product.

Validation:

  1. DQ/IQ/OQ (supporting) activities;
  2. PQ activities and responsibility for their execution;
  3. issuing of DQ/IQ/OQ/PQ final reports (support);
  4. documented verification regarding:
    • the facilities, the equipment, as installed and operated, and the production environment are in compliance with the technological process and the know-how;
    • all the above is capable to produce the semi-finished and finished products based on them in conformance with the technological process, specifications, registration dossier and the know-how;
    • the know-how has been transferred to the customer, the equipment has been purchased and successfully installed according to the technological process in a manner enabling effective production;
    • 3 (three) consecutive successive test run batches for each product have been produced successfully in order to give evidence of the consistency between the two productions/products (i.e. customer site production/products vs. Pharmland production/products).

Regulatory support (optional);

  1. support during health authority inspection;
  2. support during health authority registration dossiers evaluation.

Staff training in the following four areas:
 

  1. production (upstream-downstream; sterile production);
  2. QC;
  3. maintenance, clean rooms;
  4. QA, GMP, QC.

CONTRACT MANUFACTURING

Pharmland performs contract fractionation (toll fractionation) of plasma to produce plasma-derived intermediates (fractions I, II+III, V, cryoprecipitate, etc.), semi-finished or in-bulk products and finished medicinal products (clotting factors, albumin and immunoglobulin).

The service of Pharmland includes:

  • transportation of plasma from any collection center to the plant;
  • control and storage of plasma in the appropriate conditions;
  • plasma fractionation and preparation of plasma-derived pharmaceutical products (plasma of different origin is processed strictly separately);
  • transportation of products manufactured to the customer;
  • overall organization and service planning according to regional plasma collection rules and products demand.

For this type of service Pharmland receives a manufacturing fee per liter of plasma processed. A different mechanism of remuneration can be agreed. For example, it is possible for the customer to leave a portion of the derived products to Pharmland as partial or total payment of the manufacturing fee.

PHARMACEUTICAL PRODUCTS

Albumin solutions:

5% solution 5 ml, 20 ml, 50 ml, 100 ml, 250 ml, 500 ml;

20% solution 5 ml, 20 ml, 50 ml, 100 ml;

Package: glass bottles 5 ml, 20 ml, 50 ml / plastic multilayer polypropylene bags 100 ml, 250 ml, 500 ml.

Intravenous Immunoglobulin (IVIG) solutions:

5% 20 ml, 50 ml, 100 ml;

10% 20 ml, 50 ml;

Package: glass bottles 20 ml, 50 ml, 100 ml.

Coagulation Factor VIII:

lyophilized powder in vials. 250 I.U. per vial.10 ml + WFI vial 5 ml;

lyophilized powder in vials. 500 I.U. per vial. 10 ml + WFI vial 5 ml;

lyophilized powder in vials. 1000 I.U. per vial. 20 ml + WFI vial 10 ml;

Package: I type glass vials.

Coagulation Factor IX:

lyophilized powder in vials. 250 I.U. per vial.10 ml + WFI vial 5 ml

lyophilized powder in vials. 500 I.U. per vial. 10 ml + WFI vial 5 ml

lyophilized powder in vials. 1000 I.U. per vial. 20 ml + WFI vial 10 ml

Package: I type glass vials.