Michael Moussourakis, Senior Manager, Technical Marketing and Commercial Development, Alconox, Inc.
A: As a trusted supplier of high quality detergents to a vast array of industries including pharma and biotech, we at Alconox, Inc. prefer the model of a solution provider. This includes customer visits, site surveys, conference calls, ensuring open lines of supply to our dealer network, and other requirements based on the customers’ needs. When best practiced, this evolves into a partnership.
Critical cleaning (the level of cleaning directly impacts the value of the final product) is an increasingly scrutinized process. Analytical techniques and detection levels are continuously improving, allowing for even higher precision in cleanliness evaluation. It is here where the quality, application and product expertise at Alconox, Inc. meets the needs of scientists and engineers by not just providing solutions, but also the groundwork for strategic partnerships. Whenever increasing regulatory and cleaning demands need to be met with decreasing resources in the biopharmaceutical and cosmeceutical industries, we work as a solution provider and partner. If an existing product does not provide the solution, synergistic detergent blends and/or new product formulations can be, and have been, created. It is at these points that we evolve from suppliers to solution providers and trusted partners.
Michael Lehmann, President, Global Sales and Marketing, Patheon
A: Patheon works closely with clients to develop custom solutions that are designed to meet individual needs. This requires a strategic approach and deep understanding of each client’s challenges. Some examples of this are the unique solutions and business models that provide flexible manufacturing options to address clients’ complex needs in a changing landscape. Flexible manufacturing services complement the traditional outsourcing service model through adaptable and scalable capacity, and allow clients to increase and decrease capacity as needed. In the face of uncertain forecasts, contract development and manufacturing organizations (CDMOs) like Patheon can offer the facilities, equipment and process technology expertise needed for operations and risk management.
Christian Treitel, Pharma Business Development Head, Bosch Packaging Technology
A: As a manufacturer of processing and packaging machines, our goal is to offer customers complete line concepts from a single source. We provide our customers with one point of contact for their entire project. This not only includes the development and installation of both standard and customized solutions. Beyond machine technology, we support pharmaceutical developers and producers with market-specific expertise, as well as detailed project and integration competence. With additional services and comprehensive consulting before, during and after start-up, we make sure that all our machines and lines are optimally tailored to specific space requirements and pharmaceutical needs. This also includes qualification and validation of the lines, as well as intensive operator training and after-sales services.
Dr. Stefan Bauer, Director Global Quality, SCHOTT Pharmaceutical Packaging
A: Patients put their full trust in the industry that their drugs will contribute to their recovery and meet high quality standards.
This responsibility is borne first by the pharmaceutical company or the drug manufacturer. Nevertheless, the packaging suppliers are also under an obligation, since their primary packaging comes into direct contact with a drug. They have to deliver faultless goods to the pharmaceutical companies at the beginning of the process chain. Product mix-ups, impurities and container closure failures are among the worst possible errors in the production of pharmaceutical packaging.
SCHOTT manufactures approximately 10 billion syringes, vials, ampoules and cartridges each year and is, of course, audited regularly by pharmaceutical manufacturers. The challenge, however, is to anchor a “GMP Mindset” in the corporate philosophy that is then lived every day.
To achieve this, we launched the “100% responsibility” campaign to sensitize our employees to all aspects of quality in daily manufacturing. With a mix of information and measures that create attention, we motivate our staff to implement the guidelines of GMP on a daily basis. In addition to regular trainings, there are also posters, banners and stand-up displays at the plants using emotional imagery to appeal to employees’ sense of responsibility, and signs remind them of the most important GMP rules.
We have already rolled out the campaign with a launch event at almost all of our 16 plants. Our employees, customers and experts who have visited us since the launch of this campaign have given us positive feedback..
John Dillon, Senior Vice President, Porton Fine Chemicals
A: Porton takes the long view on building truly sustainable and mutual value-enhancing partnerships with our customers. We take a strategic alliance approach to API and drug intermediate supply relationships by understanding our customers’ pipeline development and lifecycle challenges, and applying innovative models for impactful solutions. As an example, we recently launched a Technology Center in Cranbury, NJ (Porton USA) based on our interaction with key customers and determined a need for a US-based facility that allows on site collaboration, and is capable of conducting complex chemistry, along with low volume supply of high potency compounds. Together with our existing R&D facilities in Shanghai and Chongqing and a soon to be opened Technology Center in Shuitu, China, we are able to leverage the capabilities of both sites for overall project cost and efficiency. While Porton uses several models on a best fit-to-purpose basis, we have successfully met several challenges across the life cycle for our global customers using a Service Center model wherein we take a portfolio management approach and dynamically allocate scientific resources and production assets backed by dedicated, multi-functional service teams. Working closely with customers’ program teams, our key success factors are Flexibility, Metrics (Clear definition of value-creation parameters, near and long-term goals and most feasible pathways for best outcomes) and Ownership/Delivery.
Marianne Spaene, Executive Vice President Global Business Development, Marketing & Sales, Siegfried USA
A: Siegfried’s focus is to support the common objectives and challenges of our customers and to provide value-added service offerings in order to put our customers as much as possible in advance of their competition. Therefore, we do not have one preferred model, as we recognize the important difference between strategic, tactical, and opportunistic collaborations. Strategic partnerships involve intensive exchange of information creating win-win scenarios built on the basis of transparent communication. The other two models are as equally important, but differ in that they need both intensive communication with clear understanding of expectations and project requirements, so each party understands one another’s expectation. All three partnerships require thorough evaluation and technical verification; however, the type of transparent information exchanged is different for each.
James E. Gregory, President & CEO, UPM Pharmaceuticals
A: Market analysts have predicted that as many as 30% of existing custom manufacturing organizations will be forced to exit the market in the coming years due to a variety of market and competitive pressures. Drug owners and developers are doing their part to shrink the pool, consolidating their supply chains and mitigating risk by engaging fewer, more strategically oriented suppliers. To survive, contract service providers are responding in similar fashion, acquiring and investing in the necessary assets and capabilities to deliver the flexible end-to-end development services, and manufacturing capacity contract service buyers are demanding to sustain their business models. UPM itself has made $12 million in capital expenditures in this direction over the past 24 months.
For both UPM and its strategic partners, we’ve found the most effective partnerships involve much higher levels of collaboration and integration, built on a foundation of transparent communications and trust engendered over time. Of course, reliability, quality and comprehensive value-added technical expertise are key structural components of any strategic, long-term relationship, and both organizations must contribute to operational transparency. Ultimately, the cost and time pressures faced by pharmaceutical companies to successfully bring their products to market are increasingly being met by flexible, strategically responsive partners equipped to meet pharma’s increasingly complex development and manufacturing needs.
KaShauna G. Rohlehr, PMP, Program Manager, CMO Alliance & Program Management Global Manufacturing and Supply (GMS) – Rockville,
A: Collaboration is the driving force that allows drug manufacturers to solve technical challenges, meet aggressive development timelines and bring complex products to market in record time. The best model is built on strategic partnerships that encourage collaboration externally with client personnel and internally, within the CDMO, across functions such as process development, manufacturing and quality assurance. When it comes to commercial biopharmaceutical drug development, process development is the primary mission of CDMOs active in the space, including GlaxoSmithKline Biopharmaceuticals. Process development begins with the expression system, continues through to API release, and covers both upstream and downstream operations across quality, analytical, scale-up and validation lines. The ability to customize platforms to suit customer needs and build cost-effective, robust manufacturing operations is based on two-way communication among strategically aligned collaborators. The combined expertise, knowledge and capabilities between the CDMO and client inevitably form an outcome that as a whole is greater than the sum of its parts. We’ve found clients in our space prefer closer, longer-term relationships with partners that have the culture and processes already in place to encourage a higher-order of collaboration across all functional and operational levels.
Nicholas Green, President & CEO, Therapure Biopharma Inc.
A: Our preferred model would typically be a partnership vs. transactional business relationship. However, this very much depends on perceived value in the eyes of both parties. For example, if the client is using a CMO purely as a means of accessing additional capacity, understands their process well and has internal manufacturing experience and/or capacity, relationships tend to be more transactional. In our business, as a contract, development and manufacturing organization (CDMO), we provide a complete suite of services from early process development to commercial manufacturing. As such, we are well suited for small to mid-size organizations with clients that rarely have internal capability and rely on Therapure’s development and manufacturing expertise. There is an increasing number of companies that are explicitly pursuing this strategy where each party can see significant value in the relationship, both long- and short-term. The scale of our operation, as well as the breadth of our offering, also means that clients typically view Therapure as a resource throughout the development of the product; and they ultimately expect Therapure to be their commercial supplier, if and when they ultimately gain FDA approval.