Over the past 20 years, the pharmaceutical outsourcing industry has evolved from niche, highly specialized services into an integral component of most business models and a critical link in the supply chain. Owing to market forces, including patent cliffs, a narrowing of development pipelines and the rising costs of bringing new drugs to market, big pharma has increasingly looked to build an efficiency-based model, loosening operating control and divesting assets and expertise. This has led to explosive growth in the contract services market and a continuing shift to an outsourcing model throughout the industry.
Legacy Supporting Big Pharma
Porton was initially developed through our relationships with big pharma companies. We have worked with over a dozen top 20 big pharma companies for over 10 years, including Janssen (a Johnson & Johnson company), which is one of our largest customers. Working as a supplier to big pharma — even before entering into contract manufacturing — instilled in us our strong commitment to compliance, as we mirrored the processes of our customers and optimized our business to meet global standards. Similarly, our history of working closely with big pharma customers — combined with the big pharma background of many of our prominent staff — has helped us to develop unique and relevant technical, organizational and regulatory expertise.
Porton has a history of reliable delivery combined with a very high standard of compliance, advanced technical capabilities and sophisticated management of IP issues. We have an excellent record in quality and EH&S audits with clients and global regulatory agencies and are fully compliant under GMP standards — we have been successfully inspected by the U.S. FDA, PMDA (Japan) and CFDA.
An Evolving Outsourcing Market
As the pharmaceutical industry continues to transform in response to market pressures, the outsourcing industry is reconfiguring to serve its changing needs. The costs and risks of drug discovery continue to increase, with only five of every 10,000–15,000 compounds advancing to human testing, and only one ultimately being approved for commercialization.1 Today, much of the early discovery and innovation is being performed within academia or by small/virtual pharma companies who lack any development or manufacturing resources like traditional pharma companies and fundamentally need partnerships with CROs and CDMOs to advance their concepts to the clinic and ultimately to market.
Refocusing on Growth
Observing the growing opportunity among small/virtual pharma and other customers seeking development support, we redefined Porton’s company vision and strategy after acquiring U.S.-based contract chemistry organization J-STAR Research in 2017. J-STAR has been serving as an outsourcing partner to biotechs developing APIs since it was founded in 1996 by Andrew Thompson, formerly of Merck Research Laboratories. With this acquisition, we expanded our business reach and accelerated the fulfillment of our goal to provide integrated outsourcing services in the development and manufacturing of new drugs. In addition, J-STAR Research complements the Porton Technology Center, which is also located in New Jersey. By integrating J-STAR with Porton Pharma Solutions, we have been able to match customized development capacities and advanced manufacturing expertise to better serve our customers, expanding into a full-service pharma solutions platform.
Smaller pharma companies with limited internal resources need to build long-term relationships with companies that can cost-effectively take drugs all the way from early development to commercialization.
Ongoing Investment in Technology
Technological leadership is central to our strategy to grow and deliver value to our pharmaceutical clients around the globe. Our team in New Jersey has established significant expertise in crystallization technology for solid dosage forms. We are in the process of strengthening a second team and laboratory in Shanghai as well. Through our unique partnership with Codexis, we have access to world-class biocatalysis technology that enables the development of more cost-effective and sustainable routes to pharmaceutical intermediates and APIs. Porton has implemented flow chemistry — a continuous manufacturing technology — to help increase efficiency and productivity while improving quality and consistency and reducing costs.
We have also invested in facilities and equipment for the production of highly potent APIs, including the installation of a Band 4 suite for large-scale manufacturing, and Band 5 suites for small-volume production in the laboratory (in both the United States and China). We are also exploring the use of nanotechnology to overcome the challenges of poor solubility and bioavailability, as well as other small and large molecule challenges.
Other investments are underway to expand our capacities and chemical capabilities for small molecule intermediate and API production. As importantly, we are investing in facilities, equipment and expertise to establish capabilities in biologics development and manufacturing, as well as to leverage the synergies afforded by integrated service offerings for drug product manufacturing. We are developing a business plan to ensure that we implement the most effective approaches and differentiating technologies to accelerate development and create new solutions. Newly hired subject matter experts with experience and knowledge in both drug substance and drug product development and manufacturing are helping to determine the best way forward.
World-Class Partner
U.S.-based pharma companies have long sought outsourced manufacturing services outside the United States to achieve both new efficiencies and a greater presence in foreign markets. Today, smaller pharma companies with limited internal resources need to build long-term relationships with companies that can cost-effectively take drugs all the way from early development to commercialization, including increasingly complex molecules, with the requisite IP protection, compliance, risk mitigation and speed. Their scientific experts are looking to connect with like-minded counterparts, which Porton, in conjunction with J-STAR, is eager to support.
A focus on clients and customer service is ingrained within Porton’s culture, and we believe strongly in collaboration with customers so that we can best understand their current and future needs and develop the most effective solutions to support their business. Our vision is to provide a very transparent, collaborative model that is globally compliant, mitigates risk and protects IP while optimizing efficiency for our customers.
With our high level of compliance, quality and experienced staff, state-of-the-art facilities, specialized technology platforms, record of delivery of over 50 NCE API compounds throughout the life cycle for global pharma and biotech clients and facilities in both the United States and China, Porton is not only a global CDMO, but a leading pharma solutions partner that offers highly customer-oriented collaboration and convenience, protects your IP and optimizes efficiency.
References
- Carey, Kristin and David W. Johnson. “Darwinian Outsourcing: Big Pharma Adapts to Market Realities.” 4sightHealth. 3 Apr. 2017. Web.