Pharma’s Almanac Q1 2020
Pharmaceutical companies have a responsibility to guarantee both the supply of high-quality medicines and the safety of their personnel. Next-generation pharmaceutical innovation is facilitated by collaboration with service providers with operational and regulatory experience and the right people, processes, and policies to improve productivity and efficiency while reducing costs and environmental impacts.
Critical to the success of contract partners is an efficient, agile quality control/quality assurance (QA/QC) culture underlying global, scalable networks and integrated, full-service manufacturing and supply chain services.
Evolving Pharma Business Models
To remain successful in the rapidly changing biopharma sector, pharmaceutical and biotechnology companies are evolving their business strategies. The predominant approach is to focus on core strengths and engage research, development, and manufacturing service providers to help span gaps in their capabilities and offerings.
Big pharma companies have been consolidating manufacturing capacity for advanced products and looking to outsource the production of products near the end of their patent protection or that require specialized technologies. Generic firms are subcontracting more complex (e.g., poorly soluble, sterile injectable) products that they are unable to produce within their existing infrastructure. Emerging biotech companies have limited infrastructure and resources and rely heavily on service providers across the entire development cycle. Similarly, midsize and specialty pharma companies are outsourcing significant parts of the value chain, often due to lack of capacity.
There is a general movement on the part of traditional contract manufacturing organizations (CMOs) to expand development capabilities and become CDMOs. Demand for bioproduction from CDMOs continues to increase, and many CDMOs are also investing in the digital transition, which could be a potential source of growth.
Leveraging an Effective Partnering Model
In many ways, the business models required to meet the challenges pharmaceutical companies face are addressed by the strategy Servier has been refining since its inception. Servier has leveraged an effective partnering model to establish itself as France’s second-largest pharmaceutical company, committed to developing patient-centric medicines on a global basis.
In 2015, Servier Group began offering its highly developed operations, quality culture, and global drug and supply chain development skillset to partners. As a CDMO business embedded within an internationally recognized pharmaceutical company, we bring to our pharma partners a collaborative, high-performance operational infrastructure.
At the core of our manufacturing and development offerings is Servier’s broad expertise in organic chemistry, the commercial-scale processing of hydrogenation, preparative chromatography, and crystallization processes. We also offer analytical services and extensive experience and commercial-scale manufacturing capacity for solid dosage forms, as well as a comprehensive range of packaging options and supply chain management and serialization solutions for customers around the world.
We are transitioning from a “one-stop shop” approach to a multi-local strategy to adapt ourselves to customers’ demand. An important element of this strategy is InnoONE™, our high-containment offering for commercial production of highly potent drug product at our newly installed OEB5 suite at our Arkow, Ireland facility. This upgraded facility enables flexibility in capacity and batch size and is fully integrated with all other capabilities in Servier’s global CDMO network.
Servier is positioned to manage virtually any small molecule or drug product manufacturing project from development to commercial-scale production. We are also one of pharma’s key business developers globally, meeting the needs of partners looking to manufacture locally near home markets where Servier has manufacturing sites (China, Egypt, Ireland, and Russia) or those looking to create strategic access to new international regions.
A sustainable, high-performing quality regime seeks transparency and collaboration from all facets of the organization, spanning operations, procurement, and executive management.
A Quality-Centric Approach
The success of every company developing and producing finished drug product, active pharmaceutical ingredients, excipients, or raw materials is dependent on an institutionalized quality effort. QA/QC is an essential element of operational excellence. Assuring product quality across a drug manufacturing organization requires an intensive effort, including allocating a broad range of company resources and personnel.
Strong process design and control strategies at the line level must be combined with a robust quality regime and an institutional framework designed to support an effective quality management system (QMS), quality risk management (QRM) approaches, and a continuous improvement program. It is also incumbent on the quality organization to understand process excursions and to support an effective and documented corrective and preventive actions (CAPA) program to prevent them from recurring. A sustainable, high-performing quality regime seeks transparency and collaboration from all facets of the organization, spanning operations, procurement, and executive management.
Quality has been a distinct organizational imperative and an integral element of Servier’s operational and corporate culture since its inception. Servier’s quality and compliance track record is the result of a highly developed global quality systems management (QSM) infrastructure that proactively assures international regulatory compliance and excursion-free processes — operational excellence based on six decades of QA/QC best practices and dedicated, experienced staff.
Our quality track record also reflects our “Right First Time” ethic. Proactive compliance means anticipating issues and thinking ahead so that the organization can respond more efficiently with a high-performing response. Servier’s quality team assesses regulatory guidance as it arises to determine possible impacts on operating units and to craft the best policies and cost-effective solutions.
High levels of diverse skills and leadership management are absolutely essential to our team, ensuring that everyone is qualified to manage all types of dossiers. In managing for quality, our main goal is to prevent any risk to the patient, which is achieved through a foundation built on continuous improvement. Servier adopts an interdisciplinary approach that promotes collaboration and institutional culture. Our QA/QC effort has a distinct operational/manufacturing operation bias and features interdisciplinary quality management system teams from each Servier facility. These local teams are managed by a core corporate QMS team that ensures consistency of QA/QC activities across Servier’s manufacturing operations. Combining local expertise and central quality authority also helps Servier manage its global compliance efforts effectively and assure the performance of its chemical and drug substance quality systems worldwide. Serialization has been deployed by Servier in Europe and is operational in Russia, as are tamper-evident seals used against counterfeiting.
Embedded Business Continuity Management
Pharmaceutical manufacturers, including contract development and manufacturing organizations (CDMOs), have a social and patient responsibility to ensure that the production of drug substances and final drug products are not disrupted. Beyond the need to ensure the ongoing supply of important medicines, drug companies have a responsibility to mitigate threats to their business operations and assets to protect their employees, the environment, and the local community.
Business continuity management (BCM) is an effective structured approach to meet these obligations. It is also an effective method for achieving competitive advantage for contract service providers. CDMOs with a successful BCM strategy can demonstrate to potential customers the long-term sustainability of their business. Clients have greater confidence in manufacturing partners that have resources in place to rapidly respond to potential threats to their operations.
BCM activities typically fall under the aegis of quality and risk management departments but also involve governance, information security, and compliance groups. Commitment from top management is essential to implementing an effective BCM strategy. The effort begins with performing a business impact analysis (BIA) to identify the critical operations, facilities, and equipment that may be vulnerable to disruptions, determine what the potential impacts are, and reveal gaps in the ability to overcome these losses.
Servier has two main BCM goals: (1) to reduce the probability that a disruption of our operations will occur, and, (2) in the event of an incident, to reduce the impact. We recognize that not all incidents can be prevented. With a BCM plan in place, we are prepared with equipment, procedures, and strategies designed to reduce any impact and ensure continuity or at least rapid resumption of operations. This commitment to business continuity sets us apart from other CDMOs, underscores our acceptance of our responsibility to the patients, our employees and clients, and makes Servier CDMO an excellent strategic partner.
We focus on the implementation of backup solutions for key pieces of equipment and processes, protection of our equipment and facilities, and extensive auditing and management of our suppliers, to ensure the quality, safety, and security of our manufacturing operations. Our BCM strategy often drives our operational strategy. Process mapping is performed whenever moving or changing equipment is proposed or when taking on a new project. This approach allows us to determine the choice that provides the least risk for the entire Servier group — anytime risk is reduced, performance is improved.
Regulatory Affairs Are an Integral Part of the Business Model
As demands from regulatory authorities and the complexity of projects continue to increase, we expect that more pharmaceutical companies will be seeking CDMOs that can provide reliable, robust regulatory affairs (RA) support. In addition, the smaller emerging and specialty biopharmaceutical firms developing a growing percentage of novel drug candidates do not have the experience and expertise required to ensure ongoing compliance, the development of high-quality dossiers, and the updating of dossiers for marketed products.
At Servier, we view regulatory affairs as an integral part of our business model. The RA team at Sevier that supports partner projects comprises the same experts that perform RA activities for Servier Group. Consequently, the team has extensive experience in supporting a wide range of projects for the development of both novel APIs and generic versions of existing branded products from early development stages through commercialization and throughout life cycle management efforts.
Committed to Transformational Change
With the pharmaceutical industry facing growing pressure to reduce costs and accelerate the development and commercialization of novel medicines, there is a real need to increase operational productivity and efficiency. Servier’s continuous improvement programs were delivering improvements on the order of 5%–10% annually.
Our supply chain management from procurement of raw materials to packaging components has been enhanced, as is performance with respect to quality assurance, environmental management, energy consumption, production costs, and scheduling. A right-first-time approach results in production process with minimal losses.
As a result, all employees at Servier have a better understanding of not only their responsibilities, but also their roles in the company, where the company is going, and how it will get there. All of these improvements lead to a company with enhanced corporate social responsibility and a higher level of trust with our partners across the value chain and beyond, including regulators and investors.