Since the onset of the pandemic, there’s been an increasing demand in the pharmaceutical market for groundbreaking medicines, making the landscape more intricate than ever. Drug researchers are under increasing pressure to lower prices and comply with regulations, and launching innovative drugs has become important and need of the hour.
So, amidst these regulations, outsourcing is the norm in pharmaceutical manufacturing. Many constraints, complexities, and considerations regarding distinctive drug products available in today’s market have elevated selecting a CDMO partner, making it more challenging and crucial than before.
Therefore, identifying the partner for developing and manufacturing your pharmaceutical or biopharmaceutical products is of utmost importance. Contract Development and Manufacturing Organizations (CDMOs) are vital in this process. They provide expertise and facilities to guide you through the intricate path from active pharmaceutical ingredients (APIs) to the final dosage forms.
This blog examines the essential factors in choosing the perfect CDMO partner and helps differentiate between CDMOs and Contract Research Organizations (CROs).
What is a CDMO and what to look for in a partner?
As drug substances grow more complex, pharmaceutical companies encounter numerous challenges in developing and manufacturing them. The demand for faster innovation and production to expedite market solutions, coupled with the imperative to control or decrease costs, poses significant hurdles.
Given the extra expenses associated with various equipment required for different dosage forms, such as sterile liquid, liquid and semi-solid, and solid dosage forms, pharmaceutical companies often collaborate with contract development and manufacturing organizations (CDMOs) or contract manufacturing organizations (CMOs). This partnership allows them to introduce new products or formulas without investing in additional infrastructure.
Pharmaceutical companies typically seek enduring partnerships for their outsourcing needs, aiming for long-term collaborations instead of frequent changes in CDMO partners. When choosing a partner, key factors to consider include the extent of product and process development and inquiries related to supply chain, validation, and quality assurance.
What are the attributes in selecting a CDMO partner?
There are many CDMOs to choose from, but pharmaceutical companies struggle to determine the right fit for their needs. Therefore, establishing a framework with the needs of the pharmaceutical company is essential to select a CDMO. This leads to considering and focusing on attributes that distinguish a CDMO from its competitors, to avoid delays and pitfalls.
The five important traits to look for:
- Quality- It is the most crucial attribute or trait when choosing a CDMO partner. If the final drug product doesn’t meet quality standards, all the other considerations are insignificant. Every manufacturing decision must prioritize product quality above all else, from equipment choices to staffing and processes.
- Flexibility- CDMOs must have a high range of adaptability in how they collaborate. This includes meeting the expectations of a customer regarding quality management systems, working effectively with different teams, and communicating must be personalized to meet the specific needs based on clients. These adaptations are essential for creating a flexible and efficient work environment.
- Speed- A critical factor in selecting a CDMO is having the right speed for the delivery of the right product. The process may require manual assembly, semi-automated and fully automated lines, it is necessary to employ the right speed according to the product requirements, the market, and the needs of the customer. The selection of a CDMO must be based on the balance of speed and optimal supply chain management, staffing, and process timeframes.
- Cost-effectiveness- One must use process analytical testing procedures such as in-machine inspections and non-destructive testing. This includes consistent verification at each level of the process which reduces risks and balances quality and cost, eliminating waste and labor. When selecting a CDMO, a thorough assessment is necessary. Consider the plan’s comprehensiveness, change orders, and how well it corresponds with project goals and the price logic is also critical for picking the most cost-effective alternative.
- Experience- The important measure of a manufacturing partner’s capacity is to attain the quality and scale necessary to ensure the success of a project. Pharmaceutical companies can benefit from experienced staff who possess diverse expertise in various treatment methods, administration systems, packaging options, and scales. This is valuable for companies that may not have the financial means to afford extensive revisions.
How and why to choose and partner with a CDMO?
A CDMO is considered as a one-stop solution that provides full services in both drug research and manufacturing. It contributes to simplification by offering a unified service that covers early-stage development (such as formulation, analytical testing, and process development) to late-stage development (such as clinical trial materials manufacture) and even commercial manufacturing.
Partnering with a CDMO stems from the need to leverage specialized expertise, access innovative technology, and efficiently navigate the intricate landscape of drug development. They also bring experience, allowing companies to concentrate on their core competencies while entrusting technical complexities to experts.
CDMOs possess in-depth knowledge of regulatory requirements, ensuring that products meet good quality standards and comply with regulatory agencies. Their expertise in managing biopharmaceuticals, Active Pharmaceutical Ingredients (APIs), finished dose forms, and excipients makes them the preferred choice for companies looking to optimize resource allocation and expedite time-to-market.
Therefore, we can conclude that selecting the right CDMO partner is a very strategic decision that can significantly impact the success of your pharmaceutical experimentation. Choosing by assessing CDMOs track record, technological capabilities, and expertise in handling biopharmaceuticals, APIs, finished dose forms, and excipients, you as the pharma company can make an informed choice for your drug development. Working with a CDMO simplifies the complicated process of drug development by ensuring that your product fulfills quality standards, regulatory criteria, and market requirements. As you negotiate the changing pharmaceutical market, a trustworthy CDMO partner may be your guiding light toward realizing the full potential of your product.