The pharmaceutical industry is subject to constant change. In the last decade, the production of raw materials and active ingredients in particular has increasingly been relocated to countries where production can be carried out in a more cost-effective manner. Outsourcing to external contract manufacturers, so-called “Contract Manufacturing Organizations” (CMO), has become increasingly popular.
However, the expansion of supply chains and inevitable dependence on third parties has already led to serious drug supply bottlenecks in individual cases in the past. Especially for critical, life-saving drugs. The current global COVID-19 pandemic may also lead to increased restrictions or even supply bottlenecks for medicines. However, in order to secure the supply of critical drugs in Germany and Europe, this trend towards outsourcing the CMOs could be reversed. The cost advantage of relocating production is offset by the reliability of supply.
The pharmaceutical laboratories of the Tentamus Group support pharmaceutical companies that want to take production back into their own hands. Our core competencies include:
- Analytical method transfers
- In-process controls
- Cleaning validations
- Quality controls
- Stability studies
- Release analytics
- Batch certification via a separate qualified person (QP)
Off-target studies include: hydroxychloroquines, azithromycin, remdesivir, lopinavir, ritonavir, and interferon-beta
For a few days, already approved drugs have been discussed as potential drugs for the treatment of COVID-19. For example, studies of cell cultures have shown for some time now that chloroquine can prevent many viruses from multiplying, and this is also true in vitro for the novel coronavirus Sars-CoV-2. The first clinical trials with both drugs and vaccines have already started worldwide. The World Health Organization (WHO) has announced the start of a large-scale study to determine the effect of chloroquine. The demand for drugs with these active ingredients could very soon increase.
Tentamus Pharma Labs take responsibility and relieve manufacturers in the area of quality control and release of active ingredients & excipients. The analysis of patient samples in clinical studies is also one of our core competencies. We also have the necessary capacities at short notice to support the pharmaceutical industry in the fight against the coronavirus.
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