Bridging the Gap
Quality Assured: How PCI Pharma Services helps to bring life- changing therapies to patients
sponsored by PCI
PCI is a CDMO with global presence. Our services include lyophilization and sterile fill-finish manufacturing; the development, clinical and commercial manufacture of high-potent and non-potent drug products, including solid oral, liquid and semi-solid medicines; clinical trial supply services including packaging, labelling, storage and distribution; and finally, complete commercial packaging solutions and launch capabilities. This fully integrated offering positions us as a true end-to-end supply chain partner, able to work with clients to deliver their drug products to patients anywhere in the world.
CDMOs play an essential role in the pharmaceutical industry, supporting companies to deliver products to patients swiftly and efficiently. Moreover, PCI’s flexibility and agility ensures we are well positioned to assist with any number of challenges that may arise. Biopharmaceutical drug development remains a key trend, demanding specific expertise and capabilities when it comes to Quality Assurance.
PCI has been focused on becoming a trusted CDMO partner by building strong working relationships with our clients, providing high quality on-time in-full (OTIF) services and the bespoke packaging solutions needed to meet often unique requirements. At the heart of that relationship lies effective communication as well as understanding that customers need their products to be produced at the right time, and of the right quality.
As a CDMO, we must provide consistency in approach, reliability in service, flexibility in meeting the varied nature of requirements, and true expertise in the areas contracted to us. A strong focus on identifying any issues and pursuing corrective and preventive action (CAPA) in a timely manner is also of core importance. Never should a CDMO’s skill set ever be in doubt, and everything we do should be underpinned by a robust quality framework and an understanding of the challenges specific to our customers’ products.
Meet the Authors
Rob Frater: Laboratory Manager
I have worked at the Hay-on-Wye facility for nearly six years totalling 28 years’ experience in the industry where I started out as an analytical chemist. Today I am responsible for the day-to- day lab operations, as well as managing the planning, execution, and delivery of specific client projects. I believe that the growth in biopharmaceuticals and large molecule R&D presents an interesting area of focus from an analytical perspective. Product testing is significantly different from traditional small molecule work, with challenges in terms of learning about new techniques (such as capillary electrophoresis), new applications of traditional techniques (such as liquid chromatography), and the nuances of sample handling. There are also unique challenges when it comes to biosimilar products and as such, it is a very rewarding field to work in.
Another field that interests me is the use of pre-filled syringes (PFS) and auto- injector (AI) dosage formats, and the requirements to test the functionality of such devices. Tests such as break/glide force on PFS or injection time for AIs are again a departure from typical oral dose format testing.
Arthur Stevenson: QP Services Manager, Qualified Person
I have worked in the pharmaceutical industry for over 20 years, starting in QC laboratories and then moving into Quality Assurance, becoming a Qualified Person in 2014. I’m familiar with many areas of the industry, including traditional small molecule manufacturing, but as my university degree had a heavy focus on biology, biopharma manufacturing interests me at a more fundamental level.
There are many areas working at PCI that excite me but specifically I get a lot of satisfaction working directly with clients and supporting them to get their products to market or clinic as efficiently as possible, or resolving their supply chain/compliance challenges.
Biotech and biological products have a huge role in meeting unmet patient needs by delivering life changing medications, and it is exciting to be part of that at PCI.
Both authors are based at PCI Hay-on- Wye, a commercial packaging Centre of Excellence specializing in cold chain, biologics and high potent packaging operations. The site also provides a number of support functions, including QP services, serialization, clinical trial support, analytical testing, and stability services.
Four trends that matter in biopharmaceuticals
Right now, we are noticing four areas in biologics that appear to be major talking points for our customers, which means they’re also of fundamental importance to PCI.
First, there is emphasis on the development and validation of cold chain packaging processes. As has been demonstrated with the supply of vaccines during the pandemic, it’s clear that robust cold chain management is vital. During packaging, there must be appropriate processes in place for controlling time-out-of refrigeration, and effective controls for handling materials and the associated risks. Customers also need packaging designs that maximize shelf-life and protect the product throughout the cold chain supply cycle. PCI is investing heavily in its facility in Hay-on-Wye, increasing cold- chain storage to meet the growing needs of the industry.
Second, we are seeing more interest in packaging design, with a focus on flexibility and agility, particularly for clinical trial supplies. Commercial market demands are also a major influence, and there really isn’t a one-size-fits all approach. Being able to think creatively as a solutions provider is therefore critical in this area.
Third, we are seeing demand from customers for a wide range of batch sizes, from small-scale clinical batches of a few packs (typically packed by hand) up to fully- automated, large-scale commercial packing runs. Having the flexibility and capability to provide all solutions whatever the scale vastly enhances the level of bespoke service that can be offered to clients.
Fourth, there is more recognition that method transfer management is crucial when it comes to outsourcing. Again, PCI is well accustomed to method transfer – proven time and again as new clients and projects are on-boarded, and we are trusted to support their analytical needs. However, managing biopharmaceutical method transfer can create some specific challenges. The need for advanced analytical instruments and techniques means that some testing might need to be outsourced; in such cases, PCI will work to facilitate and manage transfers between a client-contracted lab on one side and a PCI-contracted lab on the other.
With any method transfer, it’s important to quickly build up a solid understanding. We do this through research and by asking subject matter experts the right questions about the principles underlying unfamiliar techniques, including a deep dive into the critical parameters and how they may be influenced. Even where testing is on more familiar ground, such as with HPLC-based techniques, the subtleties and nuances of sample handling have to be understood and considered; even using the wrong type of HPLC vial can impact the results.
An eye on the next need
PCI is constantly monitoring the landscape to ensure that we adapt and evolve to meet customer needs, whether this be through enhancing our services, increasing cold-chain storage, adding grade-D classified packaging rooms, or investing in new skills and equipment. We also keep a keen eye on new regulations and any region-specific changes that may affect the supply chain. For example, post- Brexit, trading arrangements have unsurprisingly created challenges in the industry. However, PCI’s ability to leverage its global network means we have a robust solution: with a significant footprint in the EU, PCI is able to perform QP release upon import. The close working relationship between all sites in our network – particularly between the UK and EU sites – ensures that any challenges posed by Brexit are managed efficiently and effectively without impacting our customers’ supply chain.
At PCI, we pride ourselves on maintaining robust and effective customer communications. After all, regular and fluid communication between a customer and their chosen CDMO is essential to ensure a smooth, productive relationship, as well as resolving any issues that arise in real time. We work hard to ensure the CDMO–customer relationship is collaborative and positive which ultimately ensures that we are able to deliver on our mission of being the bridge between life changing therapies and patients.