Integrating drug substance and drug product development - Patheon
Integrating drug substance and drug product development - Patheon
Traditionally, drug substance and drug product development have been treated as separate processes, often outsourced to different third-party vendors. This approach, while common, can lead to inefficiencies and delays in overall drug development. Separating drug substance and drug product development may result in misalignments between the two processes, such as raw material supply issues or incompatible manufacturing methods, which can impede progress and increase costs. Moreover, managing multiple vendors adds complexity to project management, communication, and coordination, potentially leading to delays.
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As a result, there is a growing recognition of the need to integrate drug substance and drug product development efforts, either through in-house collaborations or through a strategic partnership with a contract development and manufacturing organization (CDMO). Integrating these activities can streamline workflows, optimize resource allocation, and accelerate the journey from molecule to medicine. In this blog, we’ll explore five best practices when integrating drug substance and drug product development and discuss why partnering with an end-to-end CDMO can prove beneficial for sponsors looking to bring new drugs to market.
Why integrate drug substance and drug product development?
By integrating drug substance and drug product development, biotechnology and pharmaceutical companies can effectively optimize processes, eliminate redundancies, and minimize delays associated with handoffs and tech transfers between different phases of drug development. Integration also facilitates early identification and mitigation of potential issues, such as formulation challenges or manufacturing constraints, leading to more informed decision-making.
Additionally, integrating drug substance and drug product development enables companies to capitalize on synergies between the two processes, allowing for greater flexibility and agility in responding to evolving project requirements. Ultimately, integration enhances collaboration, innovation, and productivity, positioning companies for success in an increasingly competitive pharmaceutical landscape while accelerating the delivery of safe and effective medications to patients.
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How can CDMOs help integrate drug substance and drug product development?
CDMOs can play a crucial role in integrating drug substance and drug product development by providing comprehensive services that cover the entire spectrum of pharmaceutical manufacturing. These integrated, end-to-end companies bring together expertise in chemistry, formulation, analytical testing, and manufacturing, offering biotech and pharma partners access to specialized capabilities and resources not typically available in-house.
Consolidating services such as API synthesis, formulation development, process optimization, scale-up, and regulatory support under one roof through a single CDMO partner simplifies the complexities and challenges associated with coordinating with multiple vendors. By serving as a strategic partner, these CDMOs can facilitate the seamless integration of drug substance and drug product development activities from concept to commercialization.
Benefits of the One-Stop-Shop CDMO | Contract Pharma
Can you do all of your food shopping at one grocery store or do you need to make visits to additional food stores to get what you need? Will one contractor provide all of the services you need to help remodel your home or will a variety of contractors be required to achieve the desired result? In today’s complex marketplace we are continuously faced with a diversity of choices and opportunities.
Luckily for us, the internet helps us research and select the product or service that best meets our exacting needs. But in today’s highly extensive, competitive world of drug developing and manufacturing where molecules continue to increase in complexity, regulations are becoming more stringent, and the costs associated with bringing drugs to market continue to escalate, maximizing the value of a complete drug package is difficult even under the best circumstances. The internet will not necessarily help provide a solution to that problem, but the selection of the right partner from the very start usually will.
An early and carefully planned drug development process is essential to achieve success. With little room for error, having the patients in mind that later must rely on the drugs that are being manufactured to help them manage their disease, making the right choice is critical. That is why outside expertise is a good approach for improving the success rate and maintaining product and process knowledge across the entire value chain. For many of these companies, reducing the number of service providers is also the desired approach as it reduces business complexity and also offers benefits over the long-term.
Today, many pharma and biotech companies frequently look to contract development manufacturing organizations (CDMOs) that have the high-level of expertise needed to help them achieve their goals and successfully cover all aspects of the processes involved. From early development support to commercial filling and secondary packaging, the accomplished CDMO can offer everything at a single source.
The CDMO accompanies the entire lifecycle of a drug product
For pharma and biotech companies, it is important to keep an eye on the market launch of the product from the very beginning of the project. An experienced CDMO can help them in different phases of the project by:
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- Selecting the most appropriate packaging material;
- Developing and implementing flexible, extendable, reproducible and efficient processes;
- Producing clinical test samples;
- Providing analytical and regulatory support;
- Scaling-up processes and technology transfers; and
- Aseptic filling of liquid or lyophilized drug substances in vials, syringes or cartridges.
Full-service CDMOs offer customers a great deal of secondary packaging services. Typical services include labeling, packaging of user sets, packaging into blister packs and cartons as well as serialization services. Customer redesign for any commercial changes driven by situations such as patient friendliness, product safety, cost efficiency and country specific requirements is also offered. For syringes and cartridges including pens and auto-injectors, a customized assembly service for e.g. safety devices is available.
The manufactured products are delivered to clients around the world. To comply with applicable drug substance-specific and regulatory requirements, a CDMO can offer cGMP storage with different temperature levels, packaging, as well as support for worldwide transportation and international logistics, compliance management, customer clearance and analytical services. Partnering with a full-service provider can help to ensure success since they are always keeping an eye on the entire value chain of a product.
The sooner the better
The establishment of a partnership early in the development process can often mean the difference between success and failure of a compound. Pharma and biotech companies benefit from a comprehensive range of products and services that are optimally tailored to meet the needs of their substances.
Experienced CDMOs have extensive and strong working relationships with regulatory authorities around the world and can support the preparation and compilation of necessary documentation for clinical trials as well as for market approval and lifecycle management activities. They can also contribute to a reduced time-to-clinic and time-to-market since they understand the issues a company faces during drug development and know how to take the compound from preclinical to commercial manufacturing in the most efficient manner possible.
This approach means there is no need to change partners, which is often a time-consuming redevelopment of manufacturing processes. The qualified CDMO understands business priorities and helps develop strategies that save time, optimize capital costs during development, preserves scarce API and enables a drug product to meet the regulatory requirements. Risk mitigation through a high-level of know-how in a wide variety of active drug substances, delivery systems and markets is also provided.
In summation
An experienced CDMO offers customer’s skilled teams with in-depth knowledge to meet a wide variety of product and patient specific needs. Quality, flexibility and a comprehensive approach to the customer needs make the difference when choosing the right partner. By outsourcing complex processes to an experienced provider, pharma and biotech companies can help accelerate their time-to-market and maximize the value of their complete drug package.
Dr. David Brett joined Vetter in as product and service manager with a focus on innovation in injectable drug-delivery systems, clinical development and commercial manufacturing. He became team leader of product and service management in , and is responsible for the development of Vetter’s service offering to optimally fit customer requirements.