Investing in a softgel manufacturing machine is a big step. However, if you make a mistake in choosing the right one, it will adversely affect the way the machine functions. You should know that running a softgel manufacturing machine is not easy and needs professional assistance. Apart from being heavy, these machines are difficult to handle. It’s best to hire professionals to do the job. Also, they are not portable.
Lessons learned from Micelle BioPharma’s acquisition of Strides Pharma’s softgel manufacturing facility in the U.S.
Strides Pharma, a global pharmaceutical company based in Bangalore, India, recently acquired the softgel manufacturing facility of Micelle BioPharma, Inc., which had previously been a partner in the deal. Strides already has eight formulation sites around the world, including one in the U.S. located at the former Endo Pharmaceutical Plant.
While the merger facilitated the creation of a diversified organization with global capabilities and a strong customer focus, it also created additional complexity for the company. Strides’ US softgel manufacturing facility is capable of producing up to 2 billion units per year and has Stelis commissions. In addition, Strides has two business verticals: biosimilars and specialty soft gelatin products.
Despite the recent success of the Florida facility, many of its existing problems remain. For example, the FDA sent a warning letter to Strides Pharma’s plant in India last month, citing the company’s “data integrity” problems. These issues will have to be resolved before Strides BioPharma can take full advantage of the Florida facility.
Challenges faced by CDMOs in producing softgels
The production of high-value formulations is one of the key differentiators for CDMOs. Customers value product quality over price and speed, and high-quality products can create competitive barriers. CDMOs that specialize in producing such products include UPM Pharmaceuticals. Listed below are some of the challenges faced by CDMOs in producing softgels. You should consider these considerations when selecting a CDMO partner.
Tight labor markets, rising costs, and a growing demand for biosimilars are among the challenges facing the industry. In addition to the shortage of labor, suppliers will experience delays due to sick employees. Inflation is also a key concern for drug sponsors. The pharmaceutical industry is dealing with these challenges and is leveraging government initiatives to create new supply chains. For CDMOs, this is an opportunity to increase flexibility, increase manufacturing capacity, and leverage growth potential.
Compliance with serialisation is another challenge. CDMOs serving the global market need to manage the complexity of multiple products on the same line while complying with multiple regulations across different markets. Fail to meet serialisation requirements can result in downtime, product shortages, and reputation damage. CDMOs serving the European market must also demonstrate proactivity with preparations. For more information, visit Erik Haeffler’s speaking session at NEXUS ’17.
Technology available to manufacturers
The new technology available to manufacturers of soft gel products is a great way to reduce the risk of unwanted stability changes. A new system can cut drying time from several days to as little as 20 hours. This is a significant time and energy savings. Additionally, it will produce a more consistent product. Manufacturers will be able to more accurately predict shelf life by using early-phase stability studies to develop new products. And this is just one example of how advanced manufacturing techniques can improve the quality of a softgel.
While softgel contract manufacturer technology has a long history, it is only recently that the convenience of this technology has made its way into the daily life of consumers. As a result, softgels have gained significant consumer acceptance. According to some market analysts, more than 80 percent of consumers find softgels easy to swallow. Over the last few years, however, many new formulation innovations have been made to help manufacturers of soft gels stand out in the increasingly competitive market. Developers must continue to improve product performance in order to compete.
Cost of manufacturing softgels
Manufacturing softgels requires precise temperature and humidity control, as well as airflow dehumidification. Softgels consist of a gelatin-based shell around a liquid fill. The shell consists of gelatin, water, opacifier, and a plasticizer (such as sorbitol or glycerin). To make the capsule, two flat ribbons are brought together on twin rotating dies.
While the consumer is the main concern, the manufacturing process can be very expensive. Large-scale manufacturing machinery and highly skilled operators are required to make softgels. Therefore, most manufacturers outsource the manufacturing of softgels. For this reason, the cost of manufacturing softgels can be a deciding factor. Some people are allergic to gelatin, which may be the most common reason for outsourcing the manufacturing of these supplements.