10 Things to Consider When Buying Drug Substance CDMO Service

Companies operating in the pharmaceutical and biotech sectors must evaluate a range of critical factors prior to partnering with a contract development and manufacturing organization (CDMO).

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Selecting and working with the right CDMO can significantly impact drug development projects' chances of success, so it is essential that companies be well-informed before committing. This article features a comprehensive guide to understanding these key considerations.

Understanding specific needs

Any company looking to work with a CDMO should begin by defining its own product's development requirements. For example, a company may be in preclinical, clinical, or commercial phase. It may also be prepared to engage an inexpensive CDMO for initial work and accept additional costs and time for tech transfer at a later phase.

Some projects require comprehensive end-to-end services, while others would benefit from support in specific areas, such as formulation or scaling up production.

Many CDMOs specialize in specific stages of development. Clearly identifying a project's stage and the services required allows companies to align their needs with a CDMO that offers complementary expertise.

This is an important consideration because a mismatch between a company's needs and the CDMO's capabilities can result in cost overruns, delays, and even regulatory setbacks. Precise alignment ultimately saves both time and money.

Evaluating experience and specialization

Not every CDMO will have equal experience across every dosage form, molecule type, and therapeutic area. It is important to thoroughly explore a potential CDMO's portfolio and look for case studies or references related to the type of drug to be developed.

If a CDMO has successfully navigated projects involving similar drugs, it is much more likely to be able to effectively manage a project's unique challenges.

Regulatory experience is also essential. The CDMO should have a track record of working with the EMA, FDA, or other regulatory bodies in a company's target markets. It is also important that the CDMO is familiar with relevant regulatory frameworks to efficiently navigate compliance.

Scalability of operations

A drug's production requirements tend to change as it moves through development stages, so it is important that the CDMO is able to scale from clinical trial production to full commercial manufacturing. With this in mind, it is also important to evaluate a CDMO's capacity to accommodate increased production volumes while maintaining quality standards.

Companies should inquire about a potential CDMO's manufacturing facilities and equipment, ensuring that it offers the capacity and flexibility to adjust to any potential production increases.

A good CDMO will employ scalable technologies that can help streamline the process, such as leveraging single-use systems in biologics. If a CDMO is unable to scale production in line with its client's needs, launches could be delayed, and costs could increase, particularly during critical phases like commercial manufacturing.

Companies looking for less expensive options may opt to work with an early-phase CDMO that focuses on early-stage drug development, including preclinical and Phase I/II clinical trials.

Early-phase CDMOs tend to be lower cost because these CDMOs do not require the expensive infrastructure required for large-scale commercial production. Their procedures are also simple, because the testing of safety and efficacy is their primary concern.

Early-phase CDMOs can deliver more rapid timelines that lower overhead, though technology transfer costs are incurred when advancements in the drug necessitate the expertise of a late-phase CDMO.

These additional costs may be worth accepting, however, because late-phase CDMOs can often offer specialist knowledge around topics like mass production and distribution. The technology transfer process can also help companies update their small, experimental batches into consistent production capable of delivering higher volumes.

Regulatory compliance and quality standards

Quality control is non-negotiable in drug manufacturing, so it is important that a CDMO adheres to good manufacturing practices (GMP) and that it successfully passes regular inspections by regulatory agencies like the FDA and EMA.

Companies should investigate a potential CDMO's compliance history in order to ensure that it meets stringent quality management systems (QMS).

Transparency in quality processes is also key, including how a potential CDMO manages inspections and audits. The CDMO should have a demonstrable history of timely regulatory approvals, and warning letters or compliance issues should be highlighted and thoroughly considered.

Communication and project management

Effective communication is the foundation of a successful partnership. Clear, consistent, and transparent communication is key to managing expectations and timelines while avoiding potential setbacks.

A CDMO should provide a dedicated project manager who will serve as a primary contact throughout the project, ensuring transparency and keeping the company informed of key milestones, updates, and challenges.

A small biotech should expect a CDMO to treat its project with the same care as the projects of big pharma clients in its portfolio.

Location and supply chain capabilities

Geographical proximity has a major impact on logistics and project management, so companies should consider the CDMO's location in relation to their own operations, particularly if the project in question involves global markets.

A good CDMO should understand specific regional regulations where a product will be marketed and be able to manage cross-border supply chains without delays. A CDMO with robust global capabilities can help streamline issues such as shipping times, customs clearance, and differences in regulatory jurisdictions.

Cost transparency and flexibility

A CDMO's pricing model should be transparent and clear. Some CDMOs work with opaque pricing structures, charging hidden fees for services like regulatory submissions, quality testing, or material procurement. It is important to request detailed cost breakdowns prior to engaging a CDMO, ensuring that the contract accounts for any potential changes in project scope.

A CDMO should also be flexible enough to manage unforeseen issues without major budget implications. It should also be able to adjust costs if the project needs to pivot or expand.

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Innovation and technological capabilities

CDMOs may be able to improve efficiency and lower costs by investing in innovative technologies and leveraging cutting-edge methods and technology. This can offer a range of advantages, but a company should also confirm whether or not these organizations will cover the costs of implementing these technologies or if the client must cover this cost.

A good CDMO will also leverage automation or data-driven analytics to improve manufacturing processes. These technologies can significantly reduce human error, streamline operations, and offer faster turnaround times.

Cultural fit and partnership philosophy

Cultural fit should never be overlooked because a company's partnership with a CDMO is a long-term engagement that can span years to decades. The CDMO should align with the company's goals, values, and underlying way of working. A robust cultural fit leads to fewer disruptions and an overall smoother, more productive, long-term relationship.

Conclusion

Working with the right CDMO can essentially make or break a drug development project.

Considering the critical factors outlined here will allow companies to select a partner that meets their technical and regulatory requirements while aligning with their long-term goals.

DS Inpharmatics' wide-ranging and comprehensive experience in guiding clients through these complex decisions ensures successful partnerships with CDMOs, streamlining the path to regulatory approval and commercial success.

Acknowledgments

Produced from materials originally authored by Meranda Parascandola from DSInpharmatics.

About Design Space InPharmatics LLC

DSI provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.

Since we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence.

Whether advocating CMC strategy, directing CMC operations, or developing CMC submission content that represents the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.

As outsourcing becomes the norm across the pharmaceutical manufacturing landscape, the complexities and considerations associated with the increasingly unique drug products on the market today have made choosing a CDMO partner more difficult ' and more critical ' than ever.

When looking for the right CDMO, pharmaceutical companies can help ensure their project's success by focusing on five primary attributes in their potential partner: quality, flexibility, speed, cost-effectiveness, and experience. By evaluating a CDMO's track record, understanding its internal processes, and gauging its willingness to conform to the processes and procedures of its clients, pharmaceutical companies can make informed choices and achieve better outcomes as a result.

The Five Key Attributes Of A Great CDMO

With hundreds of CDMOs of all different shapes and sizes to choose from, pharmaceutical companies can find themselves struggling to determine the right fit for their needs. Establishing a framework for vetting CDMOs can be the first step to success; by focusing on the attributes that distinguish a CDMO from its competitors, pharma companies can avoid the delays and pitfalls that can lead them right back to square one. Some of the most important things to look for in a CDMO partner can be found by emphasizing these five traits:

Quality:

Of the five core characteristics a pharmaceutical company should hope to find in a CDMO partner, a demonstrated focus on quality is the most important. Manufacturing partners can be fast, or comparatively inexpensive, or willing to incorporate any number of workarounds to make a project feasible, but if the final drug product falls short of commercial or regulatory quality standards, the rest of that equation ceases to matter. Every decision surrounding a manufacturing process has to be undertaken with the end product's quality in mind, from what equipment to use to which people to hire, before looking at how to save time, spend less, or move faster.

Flexibility:

Applying the concept of flexibility in the pharmaceutical space is, itself, flexible ' it can affect timelines, packaging, workflows, and processes, and can extend across business units and functions. To accommodate a range of customers, products, and processes, CDMOs must be flexible in not just how they work, but 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 core to achieving flexible, optimized workflows.

Speed:

Speed is a critical facet of a CDMO's value proposition for customers, and having the right speed for the right product and volume is the recipe for optimized scalability. From manual assembly to semi-automated and fully automated lines, employing the right speed to suit the product, the market, and the customer need is crucial. But this applies to more than manufacturing processes; having the project management tools and systems that allow a project to go from kickoff to parcel in months instead of years is equally important. Conversely, the ability to pace a project appropriately can be equally important ' finding a CDMO that can balance speed and optimized supply chain management, staffing, and process times can be just as critical as achieving an accelerated commercial launch.

Cost-effectiveness:

When it comes to cost-effectiveness, CDMOs should be positioned to leverage process analytical testing (PAT), including in-machine inspections, verifications, and non-destructive testing to control expenses. Being able to verify, using data, that an assembly is correct throughout the course of a process rather than at the end reduces risk at final release testing, marrying quality and cost by eliminating waste and lessening labor. While many pharma companies may be keen to select the CDMO with the lowest cost estimate, this inclination can end up costing them in the long run. It's important to be deliberative when comparing proposals, particularly if one stands out as markedly inexpensive when compared to the rest. How comprehensive is their plan? Is there the potential for multiple change orders? Does it truly meet every one of the project's goals? Understanding the rationale behind the price tag is important to choosing the most economical CDMO rather than the cheapest one.

Experience:

While quality is the most important consideration when choosing a CDMO, the most important clue in determining whether a manufacturing partner is capable of achieving the quality and scale needed to ensure the success of a project lies in its experience. Having both long-standing and varied experience ' encompassing a range of therapeutic modalities, delivery systems, packaging options, and scales ' can be invaluable for pharma companies, particularly ones that lack the financial resources to accommodate rework.

PCI's Value Proposition For Customers

At PCI Pharma Services, these five attributes are all part of its comprehensive approach to contract manufacturing. To ensure quality, PCI works to lower the defect rate of products by conducting more early testing and trials using placebo or water-filled syringes. Another key means of improving quality is to reduce handling, and to this end, PCI employs in-line processes from primary packaging/assembly to the carton and into the shipper, minimizing the potential for loss and streamlining manufacturing. Finally, one of the most important aspects of PCI's approach to quality is in its early process drift detection. By performing frequent machine inspections and assembly verification, as well performing testing as often as hourly rather than at the end of the batch, PCI is able to identify process drifts before they result in defects.

A key component to ensuring flexibility for PCI has been in creating multiple formats on one machine or platform, allowing users to shift between processes rather than have dedicated lines for each. This machine flexibility, when combined with an array of machines capable of performing a wide variety of processes, allows CDMOs like PCI to offer quick start-up and streamlined scale-up, both of which are valuable for customers at every phase of development. Equipment like PCI's autoinjector assembly lines, which can transition between producing three separate makes of device with streamlined retooling and changeover, are just one example of the access to resources customers are afforded to meet the demands of their manufacturing paradigms.

In providing a one-stop-shop for customers that allows them to scale up seamlessly, PCI offers solutions to fit nearly any manufacturing scenario. Its Biotech Center of Excellence, which was recently expanded through major capital investment, represents PCI's commitment to creating more manufacturing capacity to support the expanding biologics space. PCI combined partnerships with leading suppliers with increased high-speed automatic syringe assembly and labeling, vial labeling and cartoning, and autoinjector assembly to revolutionize its capacity and flexibility. These improvements were coupled with building out existing cold storage capabilities and leading-edge manufacturing suites to create a comprehensive, state-of-the-art manufacturing and packaging facility.

PCI understands that by the time a customer has reached the packaging stage they are eager to finally bring a product to market, making the speed of both manufacturing and management integral to bringing their therapeutics over the commercial finish line. PCI is experienced in scaling products within highly constrained timelines; for one of its recent projects, related to vaccine production, PCI was able to scale up to commercial production within six months of receiving the order. Its ability to achieve the necessary speed to facilitate such quick turnarounds is the result of PCI's focus on quality and flexibility, coupled with its extensive experience. With facilities around the globe and leading expertise in a range of packaging options, PCI can offer customers packaging that is more economical, more environmentally benign, and even more patient-centered.

PCI has designed packaging options in the past to help facilitate self-administration of injectable medication for patients with arthritis; its experience in designing packaging that goes beyond traditional expectations can help customers realize additional value for their products in a regulatory atmosphere that places increased emphasis on patient acceptance and adherence.

While all of these factors ' quality, flexibility, cost-effectiveness, and speed ' help to make a CDMO competitive in the current market landscape, it's ultimately, experience that allows PCI to avoid past pitfalls and delays. Being able to perform equipment assessments and device selection in conjunction with device manufacturers is key to helping customers make data-informed choices regarding component selections and have design input throughout the process. Ultimately, the earlier that a CDMO like PCI is brought into the process, the more customers can leverage its expertise to avoid issues and create opportunities to be proactive.

By Alex Weaver, Sr Director of Engineering, PCI Pharma Services

We are committed to supporting clients at every stage of the manufacturing cycle, delivering best-in-class services efficiently and effectively.

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