Development of a drug isn’t just about scientific discovery; it’s also about efficient, precise, and collaborative development. For pharmaceutical companies, a successful drug depends on many specialised network partners, including API Contract Manufacturers and full-service contract manufacturers that develop or provide APIs to meet the highest quality standards for their compounds. Additionally, pharmaceutical contract manufacturers often utilise API Contract Manufacturers to help maximise the efficiency of the drug development process.
This blog will examine how pharmaceutical companies are increasingly utilising API Contract Manufacturing, the potential benefits to drug development, and how the growing trend towards strategic alliances between active pharmaceutical ingredient contract manufacturing companies and contract manufacturers is transforming the way drugs are developed.
The Growing Role of Contract Manufacturing in Pharma
The pharmaceutical industry is a competitive, high-demand market. Currently, companies are facing increasing pressures; R&D costs are becoming ever higher, regulatory requirements are becoming increasingly complex, and pressures from stakeholders to bring products to market in less time than ever. In such an environment, contract manufacturing has evolved from a convenience to a strategic necessity.
Contract manufacturing enables pharmaceutical companies to utilise a vast array of expert resources without having to invest large amounts of capital in their own manufacturing facilities or specialised equipment. In addition, contract manufacturers of small molecule active pharmaceutical ingredients (APIs) through to contract manufacturers of sophisticated biopharmaceuticals can efficiently and successfully increase their production capacity while delivering products of the highest quality.
The API contract manufacturing relationship is not limited to the actual production of drugs. Manufacturers of pharmaceuticals act as a source of partnership and serve as a consultant to pharmaceutical companies, assisting them in resolving regulatory concerns, optimising supply chains and, on occasion, rapidly adapting to changing market demands typically not available to them via in-house production.
API Contract Manufacturing: The Engine Behind Modern Medicines
The Active Pharmaceutical Ingredient (API) is the primary component of any pharmaceutical product that creates the therapeutic benefit of that product. Manufacturers of APIs must follow strict regulations and can only produce APIs in large quantities when they have the appropriate experience and specialised facilities available to them.
These are a few of the advantages of using API contract manufacturing:
- Access to Expertise & Technology: Pharmaceutical companies use contract manufacturers to leverage advanced technologies without having to invest in developing these capabilities in-house.
- Ability to Scale Up or Down Quickly: API contract manufacturing companies can change the amount produced as needed throughout the development life cycle, from clinical trials through to commercial production.
- Cost Savings: Contract manufacturing eliminates the financial burden associated with maintaining a specialised infrastructure, including the costs associated with regulatory compliance and employing highly trained personnel.
- Regulatory Compliance Knowledge: Experienced contract manufacturers understand and operate in accordance with the many global standards that apply to API production, thereby decreasing the risk of non-compliance for their pharmaceutical clients.
An example would be a small biotech startup that is developing a new antiviral drug and lacks the resources to manufacture these products at the required commercial scale. The biotech startup can enter into a contract with an experienced active pharmaceutical ingredient contract manufacturing company that can produce the necessary product in compliance with all regulations and on time, so that the startup can continue to innovate.
Pharma Contract Companies: More Than Just Manufacturers
Most people consider active pharmaceutical ingredient contract manufacturing companies as simply being focused on manufacturing products. However, the functions of a pharmaceutical contract manufacturing company have significantly evolved. Today, a contract manufacturer is viewed as a partner who provides Additional Services in addition to Manufacturing during the entire Drug Development process through Commercial Launch.
The following are some examples of the additional services that pharmaceutical contract manufacturers provide:
- Process Improvement & Optimisation: Pharma contract companies help improve an Organisation’s Manufacturing processes by optimising Efficiency within the Manufacturing Process, thus allowing the Organisation to save money and improve yield.
- Providing Guidance Related to Regulatory Approvals: Pharmaceutical contract manufacturers assist their customers in navigating Complex Regulatory approval Processes throughout multiple Regulatory Agencies throughout the world.
- Flexible Supply Chain Management: Pharmaceutical contract manufacturers provide customers with the ability to produce products at multiple manufacturing locations (e.g., factories) so that the Organisation can be Flexible and resilient in the face of Disruptions affecting any Factory.
- Innovation-Related Partnerships: Contract manufacturers and their customers frequently form Partnerships to help each other develop Novel Drug Delivery Systems or Unique Formulations.
The importance of supporting organisations in developing New Therapeutic Areas and/or expanding internationally cannot be overemphasised, particularly when many regulatory issues create different Regulatory environments in each country. Thus, having a knowledgeable partner can mean the difference between successful market entry and delays that can result in significant financial losses.
Customization & Flexibility: The New Standard in API Production
API Contract Manufacturing is an excellent opportunity for companies to create the exact type of product they need using the latest technology and processes available. Today’s APIs are often made up of many molecules; therefore, they must have an accurate molecular structure, controlled particle size, and a very high purity level. A batch of API could potentially vary from one batch to another, so having an API contract manufacturing experience in creating a custom product that meets the customer’s specifications will give that customer peace of mind.
Committing to a contract manufacturer with state-of-the-art technology, robust quality control and robust process monitoring capability allows a pharmaceutical company to:
- Rapidly advance promising drugs through discovery and into clinical trials.
- Tailor a drug formulation for multiple modes of delivery, such as oral tablets, injectable routes, and inhalable therapies.
- Minimise production constraints and continue to produce the same quality of product for each batch created.
The need for increased customisation for BioTechnology-based products becomes even more pressing because they are manufactured using living cells. A contract manufacturer in the Pharmaceutical industry can develop and implement the numerous complicated upstream and downstream manufacturing processes required to manufacture Biologics, which would otherwise be prohibitively expensive to develop internally.
Driving Innovation Through Strategic Partnerships
Pharmaceutical organisations that have been successful in driving creativity within their business do so by building partnerships that allow for true collaboration between manufacturers and pharmaceutical companies, which brings about true innovation. Pharma contract companies are reliable sources for their expertise on how to save costs based on efficiency of the process, formula innovation and market needs.
Examples of innovative approaches include:
- The use of Continuous Manufacturing, where instead of batch processing, there is the use of continuous processes and Equipment and operations that improve efficiency.
- Adoption of Green chemistry, which reduces waste, energy consumption and maintains the required level of quality of products.
- Digital Integration, the use of IoT’s Artificial Intelligence to assist in the monitoring of production and the prediction of maintenance times.
All three of these examples not only provide for cost savings but also significantly reduce the time frames of product development, enabling more rapid introduction of new therapies to patients.
Conclusion: From Partnership to Progress
The process of innovating pharmaceuticals goes beyond the actual discovery of drugs. It includes working together as well as being accurate and dependable. APIs (active pharmaceutical ingredients) and pharma contract companies in the medical industry are not just businesses that supply medicines; they provide companies in the sector with means through which to make progress toward improving the lives of patients and gaining efficiency while helping patients access safe and effective treatments.
To achieve this goal, pharmaceutical organisations should choose their partnership organisations carefully based on their capabilities to provide assistance, flexibility, and regulatory knowledge, so that active pharmaceutical ingredient contract manufacturing companies can put all of their attention on developing and providing the best quality, most effective, and innovative therapies to their patients.
The right partnerships will not only help an organisation grow; they will also assist organisations in accelerating that growth within an extremely convoluted industry.