what we do

Discover how we set up and operate
biomanufacturing facilities

Our role

Faced with an epidemic of chronic non-communicable diseases such as diabetes, cancers, and autoimmune diseases, the need for biologics in low-to-middle income countries is acute and growing.

At the same time, in countries whose economies are moving beyond the threshold at which GAVI supports their vaccination programmes, there are not enough vaccines to prevent the spread of virulent, transmittable diseases.

The Covid-19 pandemic is highlighting health inequalities around the world – and the inextricable link between strong health systems and economic sustainability.

Solving the challenge of healthcare access in emerging markets requires more than just the supply of low-cost biologics.

Creating national and regional health capacity requires a range of stakeholders (multiple private and public sector partners and agencies) to work together. Few international organizations have the know-how, human resources and commitment to make this happen.

By working on the ground to implement local bio-manufacturing solutions, and linking them to robust, practical healthcare systems, we are dismantling an important barrier to better health and prosperity.

Unizima delivers international biomanufacturing projects

Unizima delivers international bio-
manufacturing projects

Unizima delivers international biomanufacturing projects from inception to technology transfer and validation. We bring together all the elements needed to make the project a reality, we manage it and offer operational support to ensure successful continued operation. Our operational support services cover quality control, supply chain, and digital oversight. We also devise and implement bioproduction training programs, and design and build care centers and diagnostics surveillance centers.

Our deployment model
covers four broad areas.

integrated services
Feasibility studies (market landscape analysis, business case development), in-licensing support and conceptual design up to QMS, CQV and Regulatory Affairs support
modular solution deployment
Rapidly deployed, modularized facilities
for drug substance and drug product manufacture.
WORKFORCE development
Specialized training to increase the proficiency
of the local biomanufacturing ecosystem.
Full tech transfer support for drug substance
and drug product, including analytics.

Track Record

Unizima is consulting on several projects around the World.

Case study #1

Unizima project managed and supported the design of a vaccine manufacturing facility.

The national government gave our client a mandate to establish a COVID19 vaccine production facility to reduce its dependency on supply from other countries. This formed part of a larger ambition to set up a flexible and modular vaccine production unit to produce a wide range of vaccines in the future

The wide range of stakeholders involved in the project required us to include all organizations in the project oversight and to coordinate with other ongoing initiatives, without over complicating the execution of the project. We took on this role and ensured that all parties were represented while ensuring effective project decision making and efficient operations.

While effective project oversight and integration are key to the success of the project, this can only be achieved if it is coupled with a presence on the ground to ensure effective project execution. Getting local stakeholders to adopt the project is key to integrating local needs and adapting to local realities which is essential for its ultimate success.

Case study #2

Delivered a diagnosis, feasibility study and concept design for setting-up a biomanufacturing facility for a private pharmaceutical company.

The client wanted to broaden its current manufacturing capabilities to include vaccine production to address the current demand for COVID19 vaccines and expand its local biomanufacturing expertise.

We provided a situation and gap analysis of the client’s existing biotech manufacturing capacity and capabilities. This was followed by a feasibility study and conceptual design to allow the client to set up both a fill-finish facility and a drug substance facility for COVID19 vaccines.

The conceptual design included providing process flows charts, manufacturing room layouts, a list of process equipment, dirty and clean utilities, as well as the assessment of project HR requirements, project planning, project CAPEX and OPEX, operational teams and training needs.

We endeavoured to re-use as much of the client’s current capacity as possible. To achieve this, we proposed adapting the existing facility to be ready for fill-finish of a COVID19 drug product while the drug substance platforms were designed enabling the client to achieve their goals faster.

Case study #3

Strategic consultancy services for a pharma company aiming to expand their biosimilars portfolio.

A pharmaceutical company in the Middle East and North Africa (MENA) region wanted to expand their biopharmaceutical product portfolio. Their challenge was to find Licensors willing to out-license the drug substance production technology to them.

Together with the client, Unizima created a shortlist of biosimilar products that would be most complementary to their current product offering, and which represented an attractive business opportunity.  Unizima scoped the licensor landscape, engaged product licensors and presented them with the client’s project to evaluate potential collaboration possibilities. Technical discussions were held with selected licensors to assess compatibility after which non-binding term sheets were obtained for the products of interest. 

Unizima will support the due diligence of the products for which non-binding term sheets have been agreed and will negotiate binding supply contracts.

In due course, Unizima will execute a conceptual design study for the biosimilars investment project (drug substance and drug product manufacturing) and map the gaps and requirements needed to support future technology transfer of the biosimilars manufacturing process.

The conceptual design included providing process flows charts, manufacturing room layouts, a list of process equipment, dirty and clean utilities, as well as the assessment of project HR requirements, project planning, project CAPEX and OPEX, operational teams and training needs.

While defining the shortlist of biosimilars, we realized that there was a need for quicker and easier access to product licensors to be able to evaluate potential collaboration. This insight prompted Unizima to create a relationship with licensors to facilitate new customers/licensors collaboration that could benefit both parties.

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Unizima is offering the following integrated project delivery method as part of a unique value proposition for its customers, allowing them to lean on a preferred intermediary, offering a turnkey solution.