Polypharma product manufacturing support for MENA drug producers

Polypharma Technologies & Sciences GmbH (Polypharma) can provide support for product manufacturing of drugs in non-traditional markets, particularly in Middle East and North Africa (MENA) regions.

Polypharma can provide solutions in how to manufacture a product that can include: antibiotics, alpha- and beta-blockers, alkaloids, analgesics, antacids, antidiabetics, antiemetics, antihelminthics, antihistamines, antimycotics, antiresorptives, cytostatics, corticoids, diuretics, hormones, immunosuppressants, schizonticides, antipsychotics, statins, virustatics, and vitamins.

Polypharma product design manufacturing portfolio

Polypharma’s expert consultants can provide practical advice and detailed guidance on  the manufacturing aspects of dossier development, sourcing and supply of pharmaceutical raw materials, such as APIs and excipients, product design and manufacturing of generic drugs, support in plant construction, technical advice on laboratory fitting out and routines, support in meeting regulations for validation batches, support with registering and validating new facilities, along with market research and feasibility studies.

Much of this support comes from consultants with many years of experience in supporting private investors and companies in the development of pharmaceutical facilities in East and West Africa and the Middle East.

Plant construction

Polypharma offers a professional and comprehensive service for the construction of a pharmaceutical plant that includes the detailed design of products and processes for successful manufacturing.

Even before thinking about manufacturing and construction measures, finished product ranges should be based on analysis of the local market, potential competition and possibility of economic production.

If all the criteria are favorable, a detailed construction plan and timeline for the manufacturing building can be prepared, including compliance with ICH guidelines and therefore GMP standards.

End-to-end full service

Polypharma adopts the role of skilful partner that can supports generic drugs producers in all aspects of producing finished formulations, from initial manufacturing concept, through delivering dossier,  through manufacturing process definition and sourcing materials, to manufacturing products at commercial scale.

A pharmaceutical production is a complex process, where a number of checks, tests and documents need to be taken into consideration. These include procurement of production and manufacturing licenses, manufacturing process definition through the technical dossiers, making of laboratory and validation charges needed for the registration, and securing marketing approval.

In African and Middle Eastern countries increasingly aware of the importance of developing local production, public financing funds may also be available and Polypharma can advise and guide manufacturers in obtaining grant or subsidy.

Project planning

Polypharma can support partners according to their situations in all stages related to the development and production of generics. This support can encompass market analyses, feasibility studies, design of product range to be manufactured, technology transfer of the analytical data and production processes in manufacturing, supply of raw materials to produce validation and industrial batches, and supply of reference substances, reagents and HPLC columns required for analysis.

A detailed market analysis is essential in project planning as the choice of generic drugs will be based on the market needs and the technical feasibility that is the key to economic production. For this phase of the project it is necessary to determine:

• Which dosage forms can be produced with existing production machinery
• Whether further equipment is required for specific medicines or dosages, such as additional tablet punches
• If the conditions for the manufacturing of special products are fulfilled or if an adjustment can be carried out

Technology transfer

As an experienced specialist, Polypharma has successfully supported generics manufacturers in Africa and the Middle East in product planning, designing the manufacturing process and consequent production analysis into precise manufacturing process steps.

The manufacturing design process service includes a technology transfer of a manufacturing process design proved by successfully producing validation lots for the registration process.

For joint quality control, Polypharma supports the product manufacturing process with technical guidance on weighing and preparation of raw materials, manufacturing process design, production machine specifications, and filling / packing in primary and secondary packaging.

During this process, its technical teams work hand-in-hand with client production and analytical teams on such aspects as analytical validation, process verification, storage inspection, quality control testing, environmental checking, and in-process troubleshooting.

Scale-Up Service

When upgrading to larger production machinery, it is particularly important to review the process of manufacturing from the beginning. Production machines must be adjusted to produce the specific generics and the quality of the generic must be controlled against the defined fill quantity and dosing specifications. Along with benefits of faster production due to larger batches, it is equally important to consider how changeover will, among other things, increase mixing times to ensure homogeneity.

If a changeover in the production process from a smaller batch quantity to a larger batch takes place, Polypharma can advise on how scale-up can be implemented to support the client production manufacture team.

Product design manufacturing analysis

Polypharma-supplied drug dossiers and master files (DMFs), fully describe the complete analytical approach of the active substance and the finished drug.

Polypharma can bring detailed knowledge and tools to bear on three interrelated analyses:

• Active substance analysis: Analysis of active substances should be carried out directly on each incoming delivery and repeated before use in the manufacture of medicines.
• Analysis of production lots: validation lots are jointly analyzed directly on site and the conformity of the generic product is ensured. These tasks can be carried out by Polypharma in collaboration with the client analysis team directly during the technology transfer.
• Analysis of stability lots: Stability data gathered during analysis of the production lots is of enormous significance for the submission of the dossier for marketing authorisation. According to ICH guidelines, specific long-term stability and stress tests, are required to demonstrate the compliance of the medicinal product over the shelf-life period.

On-site service

Polypharma offers its partners individualized assistance at the actual production site. Considering site, budget and local market needs, the Polypharma team can provide detailed guidance on the precise manufacturing steps required for successful production of a generic drug.

If the project is for the creation of a new product manufacturing site, Polypharma can participate in a joint feasibility study, again based locally.

Resources

Click on Dossier development for production for further information.
Click on Raw material sourcing and supply for further information.
Click on Production plant construction for further information.
Click on Project planning for further information.