Q&A West Pharmaceuticals: The essentials of contract manufacturing

EPM speaks to Patrick Malone, vice president, Operations, Contract Manufacturing at West Pharmaceutical Services, about the essentials in contract manufacturing and the latest trends affect manufacturers.

Why are more pharma companies outsourcing their manufacturing requirements? 

Outsourcing is a strategy that many pharma companies use to remain competitive, reduce infrastructure and overhead expenses, and improve their operational efficiencies.  It also allows them to focus on formulation and drug development and provides the flexibility needed in a fast paced, ever-evolving market.

How are CMOs preparing for advances in manufacturing such as continuous & Industry 4.0? 

Industry 4.0 typically refers to the use of data and automation in manufacturing.  Simulation, additive manufacturing, data & analytics and augmented reality are technologies that are currently being used to create “smart factories” where systems, machines and people work together to rapidly design or create something while improving efficiencies and eliminating errors. CMOs are getting their house in order - through Improvements in infrastructure. It is important to have the right infrastructure, security, systems and data storage - not to mention, an exceptional talent pool to support these technologies and market growth.

What advice would you give to customers working with CMOs for the first time?  

Strategic partnerships should be mutually beneficial and collaborative in nature. Partnering with a CMO can have many benefits, including innovative strategies that mitigate risk and improve time to market. Understand if the CMO is a leader in their given market - do they offer end-to-end solutions, and can they support scale up strategies including clinical trials, HF support, regulatory, analytical testing and device manufacturing and life-cycle management?

What trends are you expecting to occur within the CMO market over the next few years?

We expect to see increasing demand for biologics and generics as well as biosimilars. Due to the capital-intensive nature of the business and complex manufacturing requirements, pharma will continue to rely on CM partners that can offer an integrated approach to services from packaging, testing, filling, device assembly and final packaging – both for commercial and clinical production. This is all in an effort to mitigate risk, streamline their supply chain and meet time-to-market expectations. 

How do you ensure good project management when working with pharma companies?

When managing projects with pharma companies, it is important to understand and manage the project scope and have clear alignment on resource requirements, project timeline, budget and possible risks and mitigation strategies. An understanding of the regulatory and compliance strategies is also important. Finally, establishing a project management governance process is also a critical element of effective project management.

How does West ensure it stays on top of advancements in the industry – i.e. new packaging requirements or drug delivery solutions for biopharma? 

West stays current on advancements in the industry through a variety of methods:

Participation in industry consortiums and engagement with industry groups and standard setting organisations.  

• Participation in key industry conferences and trade shows which provide excellent opportunities to engage with customers and share knowledge of industry trends and needs. 
• Utilisation of a customer advisory board to maintain ongoing dialogue with industry leaders, providing the ability to better to understand their challenges and opportunities.   

Do you find pharma companies wanting more integrated services from CMOs rather than having to work with multiple companies on different stages of a product’s lifecycle? 

It is common that pharma companies will want integrated services from CMO’s and most will have a desire to create strategic partnerships with CMOs.  Through the creation of strategic partnerships, pharma companies will ensure access to advanced technology, gain capacity and scalability and have access to a global manufacturing footprint that will mitigate risk and facilitate entry into emerging markets.  

What are some of the biggest regulatory hurdles CMOs working in pharma face?

CMOs contribute information and data to their customer’s regulatory filings and are responsible for ensuring all quality requirements are met. Regulatory requirements vary across different countries so a CMO must understand the regulatory landscape and align to their customer’s product distribution strategy. An agile quality system is a requirement in meeting a broad set of regulatory requirements. Timing and uncertainty around regulatory clearance/approval can also present a challenge to CMOs. Clear communication with the customer around this timing is important as CMO’s need to effectively plan their capacity to support their customer launch and market expansion needs.

How has Covid-19 affected West’s operations and what is the company doing to help the situation?

The Covid-19 pandemic has created unprecedented circumstances for our operations. From the beginning of this pandemic, our top priority has been the health and safety or our team members, while effectively balancing our commitments to our customers. Strict protocols were implemented to ensure a safe work environment for all our team members, including:

• Implementing remote working for all those whose responsibilities did not require them to be onsite.
• Restricting external visitors to our plants.
• Restricting travel and cross-site visits for West team members.
• Social distancing practices, including staggering of shifts and break times.
• Implementing door screening and use of PPE such as face coverings.
• Focusing on team member education, including best practices for limiting the risk of virus transmission, at work and outside of work.
• Requiring team members who exhibited Covid-19 symptoms or similar flu-like symptoms to stay home, seek medical attention and get tested for Covid, if appropriate.  
• Modifying HR policies to support additional paid sick time and altering attendance policies, and waiving co-pays for certain healthcare benefits.
• Offering additional childcare benefits to support our team members who needed to be onsite, but required unplanned and unbudgeted alternate childcare as a result of schools being closed.

We are also actively engaged in supporting efforts to ensure rapid Covid-19 test solutions are available and preparing to provide products to assist with effective and safe delivery of new vaccines that will be developed.