What to look for in a fill & finish partner
Biopharmaceuticals have complex molecular structures, and developing and running the fill & finish processes to manufacture the dosage forms are challenging. Having the right CDMO partner is key to bringing these complex projects across the finish line. But what should one look for when selecting a partner?
Strong quality track record
First and foremost, they must have exemplary quality standards. You will be entrusting your extremely valuable product to them, and you must be confident it will be handled carefully. Do they have a strong track record in aseptic techniques, and do they have comprehensive systems in place for checking the process and the product?
Maintaining sterility throughout the fill & finish process is paramount if microbial contamination is to be avoided, and regular monitoring of the cleanroom environment is essential to show that the air, surfaces and personnel within the filling area achieve all required cleanliness standards. This extends to cleaning and validation, ensuring cross-contamination between batches cannot occur.
Following controls and procedures
There are many other standards you must be confident they can meet. For example, the fill must be accurate to ensure dosage uniformity, and validation and regular calibration of the equipment is vital. Robust in-process controls must be in place to monitor critical parameters such as fill volume, temperature and pressure, with real-time monitoring to detect deviations quickly. And, of course, it is essential that all personnel involved have comprehensive training, and adhere to correct procedures at all times.
Ensuring product integrity
Another vital factor is ensuring the biologic itself remains intact throughout, with regular checks made for changes such as protein aggregation or degradation. The integrity of the containers and closures must also be ensured – and validated.
Of course, all fill & finish activities must comply with GMP standards and all other regulatory requirements. Comprehensive and accurate documentation must be kept throughout, and then thorough quality control testing carried out on the final product to verify its safety, potency and purity, including release testing.
From early development to industrialization
Other considerations may assist in achieving a product that meets all requirements in a timely fashion. One is whether the provider can support your project all the way from early development through to commercial launch quantities. Transferring manufacturing processes from one provider to another as a project progresses inevitably introduces delays. If a company works with a single CDMO throughout, it will shorten the development timeline, and eliminate many avoidable scale-up risks.
Meeting regulatory requirements
Ultimately, when selecting a fill & finish partner, can you be confident they will meet all regulatory quality requirements? Choosing the right partner will ensure all essential aspects are covered. The safety of patients depends on it.
Underpinning everything we do here at Siegfried is our reputation for the highest quality across the board. We can make the small quantities required for early clinical studies, all the way up to production on a commercial scale, with multiple filling lines that can handle vials as small as 2ml, and as large as 250ml.
Our track record speaks for itself. A great example is our work on the first Covid vaccines. We set up aseptic fill & finish capacity specifically for these vaccines in record time, and by the end of 2022 we had filled several hundred million doses of the Pfizer/BioNTech vaccine Comirnaty. This included solving some significant issues related to the temperature. We regularly work at –40°C, but can go as low as –80°C where required, and this was key to the success of the Covid vaccine project.
Our strict adherence to aseptic processing techniques is paramount, with careful consideration of all aspects of the operation, from starting materials and equipment to air quality and surface sterility, and deep understanding of the complex supply chains that underpin it all. And, of course, we have a group of highly skilled operators who will do whatever it takes to make your project work.