Tuesday, January 31, 2023

Why Pharmaceutical Companies Need to Partner with a CDMO Pharmaceutical Company

 

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Pharmaceutical companies face a slew of challenges during the long and complex processes involved in developing and manufacturing new drug substances. A partnership with the right CDMO pharmaceutical company can help reduce these processes through expertise, scalability, and cost savings and introduce the best pharmaceutical products to the market.

Introducing something new into the pharmaceutical industry needs to be well-planned. A skilled hand will always be required to anticipate the challenges in the new drug formulation, development, and manufacturing process. It necessitates knowledge and experience. To meet this demand, outsourcing drug product development and manufacturing with contract manufacturers has become the new routine practice of the market.

It is a trend with many leading drug manufacturing companies in the industry. CDMOs, contract development organizations, and manufacturing organizations are the most popular and in-demand business models in the pharmaceutical industry today. They are being regarded as the best path to success due to their ability to provide end-to-end solutions.

The Advantages of Partnering with a CDMO

CDMOs provide pharmaceutical companies with services and support ranging from drug discovery to manufacturing, with comprehensive services in each phase of bringing a drug to market. As the demand for large molecule biologics rises in the aftermath of COVID-19, an increasing number of biopharmaceutical companies are slowly recognizing the benefits of partnering with an experienced CDMO.

Here are some advantages of collaborating with a CDMO pharmaceutical company:

End-to-End Expertise

CDMOs provide additional expertise by providing researchers with the necessary experience and specialized skills at each drug development and manufacturing stage without increasing payroll costs.

Capacity to Scale

Adding a new drug variant or shifting production volume to meet increased demand can jeopardize a project by causing it to miss production deadlines or lose quality and homogeneity. Using a CDMO to help with scale-up reduces risk and shortens lead times.

A typical full-service CDMO pharmaceutical company helps pharmaceutical companies to remain lean and agile while receiving extensive, differentiated development and support. Companies offering specialized services such as a solid dose CDMO provide greater flexibility and effortless cash flow than would be achievable internally. Outsourcing also frees up time and resources to focus on drug discovery and marketing, propelling the pharmaceutical industry forward.

Facilities and Equipment

Manufacturing various drug forms necessitates a wide range of equipment, and the costs are high. Collaborating with a CDMO pharmaceutical company reduces or eliminates the need to build and staff manufacturing facilities and invest in costly equipment.

Regulatory Assistance

One of the most demanding challenges for the biopharmaceutical industry is keeping up with constantly changing regulations. The regulatory submission process is lengthy and complicated. It is also costly if something goes wrong and requires resubmission. Having regulatory support can mean the difference between being the first to market and owning the market space or being late and getting a smaller share of the market.

Experience/Expertise

The expertise and insane amount of highly skilled staff you'll find in a liquid manufacturing CDMO is astonishing. CDMOs invest heavily in their employees and typically have highly qualified chemists, engineers, R&D professionals, researchers, and manufacturing personnel. Without these resources, a company is likely to waste time and money repeating experiments. Access to appropriate expertise shortens timelines and improves overall product quality.

Conclusion

The evolution of a new biologic is a lengthy and costly undertaking. This is why pharmaceutical companies partner with a specialized CDMO pharmaceutical company for biological formulation development and manufacturing, as they can benefit without having to setup their own manufacturing division. Despite the clear advantage, it is crucial for businesses to understand whether a CDMO can provide the service you require before onboarding them.

Considerations for Choosing a CDMO Pharmaceutical Company

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As outsourcing becomes more common in the pharmaceutical manufacturing landscape, the complexities and considerations associated with today's increasingly unique drug products have made selecting a suitable liquid manufacturing CDMO partner more difficult and critical than ever.

Outsourcing pharmaceutical manufacturing is becoming increasingly important for companies who want to remain competitive in the industry. The rise of small-batch personalized medicines and "virtual companies" are important motivators for maintaining flexible, external manufacturing capabilities. With so many competing CDMO pharmaceutical companies to select from, finding the right solid dose CDMO partner for your company can be challenging.
  

What To Consider When Choosing a CDMO Pharmaceutical Company

The number of contract development and manufacturing organizations has grown significantly with the increase in demand and requirements. Hence, it is no surprise that there are a plethora of CDMOs available on the market right now. With a greater number of CDMOs to choose from, pharmaceutical companies must prioritize certain CDMO selection criteria to find the best partner for their new drug development project.

Some of the most vital things to look for in a CDMO partner are:

Flexibility

Using the concept of flexibility in the pharmaceutical industry is flexible in and of itself; it can affect timelines, packaging, workflows, and processes and extend across business units and functions. To accommodate a diverse range of customers, products, and processes, CDMOs must be adaptable not only in how they work but also in how they collaborate.

Adapting to a customer's quality management systems, working with their various teams, or learning to communicate according to their specific needs are all essential to achieving flexible, optimized workflows.

Quality

A demonstrated focus on quality is probably the most important characteristic a pharmaceutical company should look for in a CDMO partner. While manufacturing partners might be willing to incorporate any number of workarounds to make a project feasible, if the final drug product falls short of commercial or regulatory quality standards, the whole point of speeding up the process becomes meaningless.

Every decision in a manufacturing process must be made with the end product's quality in mind, from what equipment to use to who to hire, before considering how to save time, spend less, or move faster.

Experience

While quality is the most important consideration when selecting a CDMO, experience is the most important clue in determining whether a manufacturing partner is capable of achieving the quality and scale required to ensure project success. Long-term and diverse experience encompassing a variety of therapeutic modalities, delivery systems, packaging options, and scales can be invaluable for pharma companies, particularly those lacking the financial resources to accommodate rework.

Cultural Harmony

When it comes to selecting a CDMO, relationships are essential. In addition to meeting all the requirements listed above, choosing a CDMO you can trust is crucial to your goals, as they will act as a true extension of your crew in the long term.

Understanding the CDMO's approach to project management is also an important part of establishing trust. It is crucial to understand how a CDMO will communicate with you throughout the project. For example, how frequently do team meetings occur?

Conclusion

It is a difficult journey to develop, scale, and bring a sterile drug product to market. Every project requires a significant investment of time and money, so finding a CDMO pharmaceutical company that will increase your chances of success is crucial. Balancing the above considerations will go a long way toward assisting you in selecting a partner you can trust with your next drug product.

If you need a solid dose CDMO that ticks all of your boxes, then Sovpharm is your best choice today. We're a pharmaceutical CDMO that guides companies through the drug discovery and development process to help create compliant and effective drug products for clinical trials.

Visit our website today!

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