Parenterals, supplied in sterile vials, ampules, syringes, and cartridges, are infused or injected into the body to treat a wide range of diseases. Parenteral delivery is a vital way of administering medicine and offers several advantages such as avoiding the effects of digestion and metabolism. Rising demand for parenteral delivery can be attributed to the number of biologics available and those in the development pipeline.

The parenteral drug manufacturing process requires proper mixing and sterile sampling for parenteral formulations, while taking into consideration operator safety, maintaining process sterility, and enabling collection of representative samples.

Having a variety of filling options and innovative equipment within a CDMO facility underscores the successful scaleup and commercial filling to meet client needs. Additionally, providing the flexibility to accommodate a variety batch sizes is key.

Paul Bolek, MSAT Supervisor, Commercial Support and Technical Services at GRAM, shares insight on successful scaleup, innovations in the fill-finish space, and the company’s unique partnership with Bausch+Stroebel.

Contract Pharma: How does equipment variety promote successful scaleup and commercial filling?

Paul Bolek: Grand River Aseptic Manufacturing (GRAM) offers some of the latest technology in parenteral filling. All four filling lines in our cutting-edge sterile filling facility are Bausch+Stroebel and are within Grade A SKAN isolators. GRAM is equipped with two four-head vial lines, one VarioSys line capable of processing vials syringes and cartridges, and one eight-head vial line. The variety of lines allows GRAM to be flexible with whatever size batch sizes come our way. We have a very knowledgeable and ambitious team who are quick thinking and can adapt to meet most needs and challenges they face. GRAM also utilizes a state-of-the-art facility to support the production process.

Contract Pharma: How do filling options relate to different types of products, and are there pros and cons to each?

Paul Bolek: GRAM utilizes rotary piston pump and peristaltic filling systems on filling lines for vials, syringes, and cartridges. This allows us to fill an extensive range of different densities and viscosities. GRAM also has a commercial scale lyophilizer, so we are capable of filling both serum and lyo products. The pro is that this gives GRAM the flexibility to take on many different projects with different profiles. 

Contract Pharma: What are the benefits to pharma/biotech clients who work with a CDMO that uses one OEM for their filling lines?

Paul Bolek: Operator/technician familiarity is the most significant benefit. Although the lines are different, the overall layout and structure of the HMI and machine construction create confidence in operators/technicians going from one line to the other. One OEM also helps with maintenance and troubleshooting issues. All the documents are laid out the same, and the technical documents and labeling are the same, which also helps with training and specialization on the equipment. Additionally, the ability to match the filling line to the project need and the ability to scale up as the project grows is a significant benefit for our customers.

Contract Pharma: How is GRAM’s relationship with Bausch+Stroebel unique? Why is that important for customers to understand?

Paul Bolek: GRAM’s relationship is unique because it has been more of a partnership rather than just “doing business” with each other. When we selected Bausch+Stroebel (B+S) to manufacture our filling lines, we understood that we would have to work with B+S for the time that we owned and operated these filling lines. GRAM and B+S also understood that we need each other to be successful, and we can work together to ensure success for a long time to come. There is also a mutual respect for each other’s expertise. We understand that they build this equipment and know it inside and out, and they understand that we are the end user and have our own experience and expertise. This mutual respect has made working together a great experience. 

Contract Pharma: What are some innovations you are seeing in the fill-finish space?

Paul Bolek: The biggest change I have seen is the evolution of isolator technology, specifically the guidance around them.  Isolators have been around for a while, but over the past 5 – 7 years, it seems like the regulatory side is starting to catch up with the innovation. I have also seen a significant increase in resources and standardization across the industry around isolator technology and processes.

Learn more at https://www.grandriverasepticmfg.com/