Impact of Supply Chain Challenges on CDMOs and Key Future Trends- Pfizer

From market experience in commercialising high-quality products, access to a global network of experts, and robust security programs for digital and IP protection, discover what makes Pfizer CentreOne an Altogether Different Kind of CDMO.

The production of oral solid dosage (OSD) forms is becoming increasingly complex as innovative techniques and technologies make it easier to harness challenging active pharmaceutical ingredients (APIs) in new medicines. Here we examine the key offerings a reliable CMDO partner must provide to successfully help support your OSD on its journey to market, and explore how Pfizer CentreOne can help.

Throughout CPHI North America (Philadelphia, PA; April 25–27, 2023), we caught up with some of the exhibiting organisations to ask what the show brings to the North American pharmaceutical sector, and what is driving industry innovation in this region of the world.  

Welcome to Pfizer CentreOne. We’re a global CDMO embedded within Pfizer and a leading supplier of specialty APIs. Working with our customers, we combine our technical and commercial knowledge with open dialogue to solve challenges – we call this intelligent collaboration.

Follow along for live updates from the Content team as we bring you the latest from CPHI North America 2023 - from session talks, panel discussions, interviews, and more, there's a lot to discover with CPHI Online at the Pennsylvania Convention Center! 

Welcome to Pfizer CentreOne. We have a global network ready to deliver end-to-end analytical and manufacturing expertise. Collaborating with you, we can help take your molecule all the way from early clinical phases through commercial manufacture and lifecycle management.

Vaccines for RSV from GSK and Pfizer to be analysed by a panel of experts with a view to informing a decision from the US FDA on their approval. 

Pfizer has the experience of taking molecules from lab to patient. Over the years we’ve learned invaluable lessons in the development of biologics and share our project management experience to support our customers’ drug strategies. Backed by Pfizer resources, we deliver technical expertise, global regulatory support and long-term supply.

For 40 years Pfizer CentreOne has been guiding drug projects to success. Here’s how our services make us an altogether different kind of CDMO: 

Pfizer CentreOne excels in the manufacture of specialty oral solid dosage forms. You can count on our devotion to you and your drug, backed by the quality of Pfizer. With Pfizer CentreOne contract manufacturing, you have our dedicated team by your side and a world of Pfizer resources at your back. The expertise you need. The attention you deserve.

Partner with creative scientists and problem-solvers dedicated to making your drug development journey a success. 

Pfizer CentreOne recently introduced Enviero Progesterone, a new green-chemistry progesterone API. It's a first-of-its-kind progesterone synthesis that reduces impact to the environment.

Understanding the complexity of HPAPI transfers is critical to successful commercialization. How should CDMO partnerships approach the challenges of HPAPI technology transfer to reach patients successfully? Kieran Coffey, Technical Services Lead at Pfizer CentreOne, discusses key considerations on this critical collaboration.

Pfizer CentreOne has been a leading provider of specialty APIs for more than 40 years. We manufacture a specific segment of complex compounds: cortico- and hormonal steroids, prostaglandins, and antibiotics.

Pfizer and BioNTech’s shot on Monday became the first COVID-19 vaccine to be granted full approval by the US Food and Drug Administration.

We are a global lead in sterile injectables fill-finish. Count on us to carefully guide your compound from development through launch.With Pfizer CentreOne contract manufacturing, you have our dedicated team by your side and a world of Pfizer resources at your back. The expertise you need. The attention you deserve.

Extra supply will bring total number of doses scheduled to be shipped to EU this year to 600 million

We specialize in small-molecule API synthesis. We can perform almost any kind of chemistry you need. You can rely on us for high-quality API synthesis, from process development through long-term supply. With Pfizer CentreOne contract manufacturing, you have our dedicated team by your side and a world of Pfizer resources at your back. The expertise you need. The attention you deserve.

Multinational makes ‘difficult decision’ to halt presence in Chinese biosimilars market five years after $350 million investment

Pharmaceutical developers are increasingly relying on external manufacturing partners for expertise to develop and commercialize their products. In fact, contract development and manufacturing organizations (CDMOs) now process and manufacture approximately 28 percent of the world’s prescription and non-prescription drugs.

Distribution of vaccine to start as early as next week after MHRA grants temporary emergency use authorisation to mRNA candidate

Innovation, compliance and agility are guiding regulatory approaches across the globe. They might have important implications for your drug program.

Results from a Phase III clinical study found Pfizer and BioNTech's mRNA-based vaccine candidate, BNT162b2, is more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection, the companies announced Monday.

Can collaborating with an embedded CDMO like Pfizer CentreOne benefit my drug program?
Yes, it can. You may have a few misconceptions about the embedded model so let’s have a look at those and how they align with our Pfizer values – courage, excellence, equity and joy.

Growing demand for pharma and biotech outsourcing presents a tremendous opportunity for CDMOs, but the impact of COVID-19 adds to a growing list of considerations for finding the right commercial partners to deliver critical medicines.  A recent CPHI webinar sponsored by Pfizer CentreOne sheds light on the latest trends in both the large and small molecule CDMO space

vaccine

In your quest to meet the regulatory requirements for your oral solids project, you may encounter significant hurdles. Anticipating these early on and thoroughly planning your approach can help. Experts in the Pfizer CentreOne global network, Gillian Miller, Process Analytical Technology and Data Analytics Lead and Beth Kendsersky, Global Regulatory Chemistry, Manufacturing and Controls (CMC) Lead, discuss common regulatory challenges and how to approach them.

Getting drugs to market faster and more economically is prompting new drug product development strategies to support better business and patient outcomes. Development of critical drug substances, particularly novel small molecule active pharmaceutical ingredients (APIs), is now being turned over to outsourced partners who have become the integral, primary drivers of the product’s overall development and go-to-market strategy.

A review of the market dynamics and drug development trends driving strategic outsourcing decisions.

In the realm of Sterile Injectables (SI), sponsors come in a variety of sizes and with a range of experience levels. The oncology segment, which will drive much of the growth in the SI market (expected CAGR of 9.1%) in the coming years, is the focus of many drug developers with significant differences when it comes to history, footprint and experience.1 The same is true for contract development and manufacturing organizations (CDMOs) and the dynamics of these outsourcing relationships have a huge influence on project success. CDMOs work with all types of sponsors, from small, emerging, sometimes virtual companies, to large biotech and pharma companies. To accommodate such variety, CDMOs must make every possible effort to customize their operations to the sponsor’s product technical needs without compromising quality or safety. The two mottos, “Right the First Time” and “No Cutting Corners Allowed” are pillars for a CDMO.

In this white paper, we discuss how a small or medium-sized biotech or pharma company can benefit from the experience and assistance provided by a CDMO.

As more and more pharma companies look to contract manufacturers for technical expertise, commercial knowledge and specialized technologies to bring their products to market, the CDMO market is more crucial than ever before in advancing the pharma industry. In a crowded marketplace, choosing the right manufacturing partner for your product is key. This webinar will examine the latest trends and developments in the large and small molecule CDMO space – from manufacturing complex products at scale, to acquiring talent and technology to future-proof Pharma.

Listening. Solving. Guiding. 

Intelligent Collaboration with Pfizer CentreOne

This panel will provide an update on the pharma regulatory landscape, addressing the following key points: Are current regulatory frameworks ready to support innovation? Balancing opportunities and challenges Novel regulatory pathways and approaches Protecting Trade Secrets in the Medical Product Approval Process Compounding challenges for the (bio)pharmaceutical industry What are the major impacts of new regulations on drug manufacturing? How to handle changes and variations in a changing environment and a Global market This presentation was originally aired as part of the CPHI Festival of Pharma.

In this presentation, three of Pfizer CentreOne’s technology transfer MVPs present the playbook for a project accelerated by the pandemic.

The team will discuss the vital moments in the project that enabled success at a pace never seen before, including: The value and need for having all parties (SMEs and decision-makers) at the table at every meeting - killing ‘we’ll get back to you’ time! Optimizing and streamlining engineering runs Better batch strategy Orchestration of effort - the need for effective vendor relationships, responsiveness and everyone knowing their role

For each, we’ll answer:

What did we use to do? What do we do now, why do we do it that way and how does it expedite timelines? All with the ultimate question in mind: how does this benefit patients?


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This webinar originally aired as part of CPHI Discover - 17-28 May 2021 As a science-based health industry, pharmaceutical professionals are always working towards improving human health and well-being. The environmental protection needed as a result of climate emergencies are an essential factor in helping to improve the health and lives of patients. With increasing international support, the climate emergency is in motion and concerns over water consumption, pharmaceuticals in the environment (PiE), antimicrobial resistance (AMR) and the industry’s reliance on fossil fuels have put pharmaceutical manufacturing practices under the spotlight as discussions around the circular economy and carbon targets dominate sustainability milestones outside of the industry. While the drive towards circularity will offer growth opportunities, natural resources efficiencies and the protection of future medicines supply, in one of the worlds most regulated industries, the pharmaceutical industry’s approach to circularity is met with several challenges including the speed of transition to new innovative technologies and the supply chain. Addressing climate emergency’s effect on public health Reuse-Recycle- what role can waste management play in improving secondary raw materials? Aligning goals and collaboration across the value chain Standardizing Sustainability: Industry progresses on setting sustainability standards

Talk of bringing back domestic manufacturing to North America has dominated conversations around pharma manufacturing for years, and have been a key talking point in government post-pandemic recovery plans, but how far have we come and who is this really working for? Asian CDMO’s recognizing the trend for western domestic production are globalizing their operations. Will there be an increase in the Civica Rx business model? This session broadcast was a part of CPHI North America Show

In this session, originally broadcast as part of the CPHI North America content programme, Pfizer CentreOne’s presenters, Tom Wilson and Nicole Strauss will take a deep dive into the recipe for supply chain management success in the face of capacity challenges. Solving those challenges revolves around trust; building it, nurturing it and utilizing it. In a way, it’s like having all the ingredients to bake the perfect cake. If you are missing a key ingredient, the whole recipe is in jeopardy. Supply chain issues and logistics can feel startlingly similar. Raw materials, schedules, processes and communication are all key elements, any of which can be thrown off track by missing components or information. Tune in now to understand how to optimise supply chain management.

Outsourcing drug manufacturing is a common solution to building manufacturing capacity among drug sponsors. Developing appropriate oversight for CDMO’s is key to a successful product launch. This session will discuss key responsibilities for drug sponsors in overseeing their providers, including which responsibilities can be delegated and when. We will also explore best practices in obtaining optimum performance and adjusting oversight as necessary to reduce overall program risk. This session was broadcast as part of CPHI NA show.

Provides an overview of PC1 as a global leading CDMO across, a wide range of services for the pharmaceutical and biotech industry, leveraging Pfizer's expertise

Where QBD was the orchestral sheet music that determined how drug product development has been harmonized over the last 15 or so years, contemporary patient-centric risk-based approaches to drug development are the pop evolution. The music is still beautiful when produced well - but the focus is no longer on the full orchestra, it's on key players and moments. First - think McCartney and Lennon - one without the other and we don’t have the Beatles. The same can be said for collaboration between drug process development and commercial production colleagues. They are central to ensuring that products are easier to transfer and can be scaled, and that manufacturing challenges are identified early on and addressed proactively. In his keynote, Bernd Schümmelfeder Director-Team Leader PPD Business Development, Pfizer explores how lyrics (communication), rhythm (standardization), bass (structured development processes), and lead guitar (the use of smart technologies) throughout the drug development process come together to create beautiful music - a drug that gets to patients safely and at pace. Key areas for discussion include: Clear decision and inflection points to manage costs and prioritize projects with a higher probability of success Smart technologies like modeling to identify challenges early on and avoid late-stage pitfalls Use of platform technologies to simplify the tech transfer process and improve process robustness Areas to optimize the product development and manufacturing process to make it more efficient, cost-effective, and patient-focused

Pfizer’s manufacturing excellence story can be likened to the sport of crew rowing. Eight people, literally rowing in the same direction in unison. Multiple efforts, focus and strengths are combined in the pursuit of a common goal. It takes precise choreography, teamwork and a common understanding of the manner in which results can and should be achieved.
“The power of the team is unlocked as each rower works in harmony, adding their power to the whole. When everyone buys in and commits to the system, great things can be achieved.”
IMEx (Integrated Manufacturing Excellence) is Pfizer’s production system that mandates a common way of working, applies that at all levels, globally and rewards individuals, teams and facilities on their outcomes. The advantages and success of IMEx are shown clearly in increased speed to patients. That’s the focal point of what Pfizer does and a tool like IMEx is important because it supports that global goal.
But how do we apply it to our CDMO business? How do we leverage such a powerful tool to create the same value for our clients? How does the coxswain and team, working together, create harmony with a supply chain that isn’t entirely our own?
Answering these questions are the crux of this presentation.