Highly complex biologics and other specialty drugs are advancing at an unprecedented pace. These products present several challenges relating to manufacturing and fill/finish operations, as well as primary packaging. Frank Heinricht, Chairman of the Board of Management at SCHOTT discusses the pharma/biopharma trends impacting primary packaging, the current challenges, and some of the latest advances.

SCHOTT, a supplier of parenteral packaging for the pharmaceutical industry, has more than 600 production lines in 13 countries that produce syringes, vials, ampoules, cartridges and special articles of tubing glass or polymer. –KB
 

Contract Pharma: What are some of the key trends in pharmaceutical packaging today?
 
Frank Heinricht: Pharmaceutical packaging needs to support the trends taking place in the overall pharmaceutical industry, which includes increased spending on flexible manufacturing, biologics and self-administered drugs, along with increased spending on drug manufacturing in fast growing regions like China and India.
 
Over two-thirds of the drugs in the development pipeline of pharmaceutical companies are highly complex biologics and other specialty drugs that are typically produced in small batches, pushing manufacturers towards smaller and leaner manufacturing operations. Subsequently, the demand for ready-to-use (RTU) components and flexible filling technologies is growing.
 
CP: What are the current challenges with primary packaging? In what areas are pharma/biopharma companies seeking more advanced packaging solutions?
 
FH: Current challenges with primary packaging are closely linked to the trends we are witnessing and mentioned above. The packaging needs to support flexible manufacturing concepts (ready-to-use), the trend towards self-administration by being compatible with drug delivery devices and needs to be available in ever-better quality in growing regional markets such as China and India.
 
Especially biologics require specialized packaging to limit the potential for drug/container interaction or contamination from extractables and leachable. This becomes highly relevant when considering so-called low-fill applications. In a standard vial, the heel region is chemically inhomogeneous after the forming process and is subsequently more likely to cause drug/container interaction. In low-fill applications, the vial is filled only to a small extent, meaning that a larger percentage of the drug liquid comes in contact with this critical bottom region of the container. This leads to a proportionally higher concentration of leached elements than with normal filling volumes.
 
As pharma companies are seeking more advanced packaging solutions, SCHOTT has introduced its next generation of vials concept. By combining a number of features, these vials offer drug stability with a homogeneous inner surface even for so-called low-fill applications and efficient and cost-competitive fill & finish.
 
CP: What are some of the latest advances with new products/technology?
 
FH: New technologies are improving drug stability and minimizing drug/container interaction during shelf life. SCHOTT recently introduced its next generation of vials, which are designed for sensitive biologics, high potent drugs or vaccines and even so-called low-fill applications. The vials are made of a Type I FIOLAX borosilicate glass with improved features and include the company’s validated delamination controlled production process, both ensuring a particularly improved resistance of the inner surface. To ensure the superior leaching profile and the delamination controlled process, the patented SCHOTT Delamination Quicktest is used as release criteria. This objective test method, which offers results within 8-10 hours, allows you to determine a threshold value for the risk of delamination. If the value is lower, the vial is able to withstand the onset of delamination.
 
The company also offers syriQ BioPure prefillable glass syringes designed to keep sensitive drugs stable over shelf life and making administration more convenient for patients. This is achieved through improved manufacturing processes leading to ultra-low tungsten and low adhesive residuals, as well as accurate dimensions for optimal device compatibility. A uniform silicone layer eases the self-administration process with for example an auto-injector. SCHOTT is currently enhancing the E&L profile of syriQ BioPure syringes with the aim to eliminate silicone as the lubricant in glass syringes in the near future.
 
These advances in primary packaging will improve the safety and stability of biologic drugs, and combat the packaging challenges associated with biologics, high potent drugs, vaccines and so-called low-fill applications.

 

Frank Heinricht took office as Chairman of the Management Board in June 2013. He is responsible for the Business Units Pharmaceutical Packaging and Tubing as well as for the Corporate Functions Research & Development, Compliance/Legal, Human Resources, Marketing and Communication and Strategic Development. In addition to his position at SCHOTT AG, he is also a vice chairman of the Supervisory Board of the Würth Group, Chairman of the Supervisory Board of Sennheiser electronic GmbH & Co. KG, President of the Federal Association of the German Glass Industry (BV Glas) and Member of the Presidential Board of The Federation of German Industries (BDI).