The best manufacturing site for a product can change throughout the life cycle. When bringing new drugs to market, biopharma companies may benefit from keeping production in the US to localize the supply chain and ensure the speed of delivery. However, the pressures on companies change as a product nears the end of the life cycle, when the process is well established and the goal is to make it cheaply and efficiently in large volumes without compromising on quality.
Choosing a drug manufacturing site based on a product';s point in the life cycle benefits patients, first by enabling rapid, reliable access to new therapeutics, and later by driving down the cost of mature products. The challenge is to find production sites that cater to both the specific priorities faced at different points in the life cycle and the universal requirements that apply to all products at all times.
Piramal Pharma Solutions (PPS) is a rare example of a CDMO that can support biopharma companies as their products move through the life cycle. With sites in the US and India that have the same quality systems and capabilities, PPS is equipped to serve both early and late life cycle products to the benefit of patients and its customers.
Piramal Pharma Solutions' manufacturing site in Sellersville, Pennsylvania has a rich history. For more than 50 years, the 31.5-acre site has been a cornerstone of drug manufacturing in the US. Today, the 21,239 square foot pharmaceutical manufacturing building at the heart of the Sellersville site is equipped to make oral solids—including potent oral solid doses— liquids, creams, and ointments. The US Food and Drug Administration (FDA) and the US Drug Enforcement Administration have inspected the facility, as has the European Medicines Agency.
At the oral solid dose side of the facility, PPS has the annual capacity to make 1.4 billion capsules and 2.5 billion tablets. The facility also houses nine manufacturing suites for creams and ointments and eight manufacturing suites for liquids. Sellersville';s liquid production capabilities include a potent suite with two rooms. The site also houses serialized packaging capabilities for oral solid dosage forms and non-serialized packaging capabilities for creams, ointments, and large-volume liquids.
.jpg "Finding a US Base for New Medicines")
The characteristics and capabilities of the site equip it to serve multiple purposes for pharma and biotech companies that want to make products in the US.
Sellersville is ideally suited for approved or nearapproval high-value new chemical entities that are expected to sell in large volumes. Biopharma companies can partner with PPS in late-phase development and use the site to manufacture the registration and commercial batches, or use Sellersville as a second source for a drug that is already on the market.
Choosing Sellersville as a production plant for a new, innovative product can be in the best interests of patients. Keeping the resource close to home can accelerate timelines and access to the material. The benefits of local production are particularly pronounced at times of disruption, as happened in the COVID-19 pandemic. While overseas sites rose to the challenge of the pandemic, onshoring can provide reassurance and resilience to mitigate the theoretical risk of an interruption to supply.
PPS is flexible about how the available space at the Sellersville site is used. Biopharma companies have the option of securing dedicated manufacturing suites and staffing them with their people to effectively rent the space. Alternatively, Piramal can handle everything for the partner by staffing and running suites dedicated to its product.
The flexibility extends to the equipment housed in the manufacturing suites. Sellersville has a wide range of advanced drug manufacturing and packaging equipment such as high shear granulators, V-blenders, roller compaction technology, and fluid bed technologies. However, some drug products are made using specific proprietary equipment that is protected by intellectual property.
PPS can accommodate biopharma companies that use proprietary equipment in the production of their medicines. The Sellersville facility is open to companies that want to house their own specific manufacturing technologies and use them in concert with the standard equipment train in place at the site. Once the biopharma company';s proprietary equipment is in place, PPS can run the whole end-to-end process if needed.
The ability to accommodate products made using proprietary equipment is one of many features that the Sellersville site shares with PPS'; oral dosage form facility in Pithampur, India. PPS has established the same quality systems and Environment, Health and Safety processes, as well as basically the same capabilities, at each site. The similarities between the two sites means biopharma companies can select a facility based on whether they are prioritizing proximity or cost.
Sellersville is physically perfectly placed to serve the US market. However, it is more expensive to make drugs in the US than in India. The Pithampur facility has been inspected by the US FDA, as well as other leading regulatory agencies, and adheres to the same high-quality standards as Sellersville and other manufacturing plants in the West.
.jpg "Moving Offshore to Lower Costs")
Yet, while the sites share the same quality practices, factors such as labor costs mean the Pithampur plant can offer reduced pricing compared to facilities in the West. Moving manufacturing from sites in the West to Pithampur realizes savings without compromising on the quality of the finished product, operations, or service. Piramal delivers 98% of projects at the Pithampur site on time and in full.
The cost savings that are possible by outsourcing production to Pithampur are particularly attractive to biopharma companies with mature products that are late in the life cycle. PPS has the capacity to make 1 billion doses of tablets, capsules, and ophthalmic liquids at the site, giving pharma companies the option to transfer the manufacture of mature products to India. The capacity is flexible enough to accommodate multiple late life cycle drug products that are needed at a wide range of different volumes. A biopharma company could take over the whole block and enlist PPS to help run it.
PPS has a track record of successfully executing tech transfers to the Pithampur facility. One large pharma company moved six products with a total volume of 1 billion units to the site to drive down costs, thereby extending the life cycle, and release internal capacity for high-value projects. PPS and the partner completed the tech transfer in 12 months.
Moving the products to Pithampur immediately reduced costs by 30%. The company realized a further 20% of cost savings by finding two new active pharmaceutical ingredient vendors, including PPS.
All told, the company realized a 25% benefit on the cost of goods sold. The smooth transfer and significant savings led the company to later transfer another four products to Pithampur.
As the example shows, biopharma companies that move the production of late life cycle products to the site will save money and free up capacity at their facilities in the West to handle newer medicines that benefit more from being made locally.
Patients are the ultimate beneficiary of the cost savings that are achieved by moving the production of mature medicines to Pithampur. Bringing down the cost of goods sold empowers companies to enter new markets and increase patient access in existing regions, making the relocation of production to Pithampur a patientcentric change.
The intense competition in the biopharma industry means companies that stand still for long periods of time risk going backwards. A manufacturing facility that was the perfect fit for a drug product when it came to market can become a drag on profits later in the life cycle. Equally, the arrangement that worked well during clinical development can fall short as a product nears the market. Biopharma companies need to continually consider the changing needs of their products to optimize production and best serve patients.
.jpg "Gaining a Competitive Advantage")
Piramal Pharma Solutions has built a global network of manufacturing facilities capable of supporting its partners as their needs change. Whether prioritizing location or costs, biopharma companies can outsource to PPS, confident in the knowledge that they will receive the same high level of service from facilities that have the same quality systems and capabilities.
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Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products and services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines and gene therapies, made possible through Piramal Pharma Limited';s associate company, Yapan Bio Private Limited.
