Biopharmaceutical packaging needs have, and continue to change, particularly where temperamental, personalized products are concerned. Packaging equipment must accommodate today’s challenging flexibility and productivity demands.  

For temperature and time sensitive biopharmaceuticals, redeveloped technologies, safety isolators, and optimized transport are essential for these valuable products. Sieghard Schuchmann, managing director at OPTIMA pharma GmbH in Schwäbisch Hall, Germany, discusses the biopharma trends impacting packaging equipment, and the latest capabilities.

For in-depth coverage of pharma and biopharma packaging equipment trends, with perspectives from both equipment manufacturers and contract packagers, see the March issue of Contract Pharma. –KB
 
Click here to see some of the latest packaging equipment from OPTIMA, Bosch, MG America and more.

Contract Pharma: What trends you’re seeing from pharma/biopharma that are impacting packaging equipment?

Sieghard Schuchmann: The number of new developments in biopharmaceutical medications is steadily increasing presenting many new challenges to the packaging process. Biopharma creates strong demand for new machines and in the coming years, we are expecting further opportunities for growth through the increase of self-medication and in the area of personalized medicine. This is because all of these areas require specific and partly redeveloped technologies.

CP: What are some of the latest capabilities with packaging equipment? In what areas do packaging challenges persist?

SS: Optima Pharma is offering several technical innovations to meet the varied requirements of biotechnological medications – identifying  the technical details and applying them to modular machine platforms is the key to success. The MultiuseFiller series is one current example of this. Two further modular and extremely flexible machine types are the Inova SV and the Optima H4. These machines are scalable in their functionality and their output, meaning that from the laboratory scale up to high-performance production, all applications are covered with flexibility.

For minimized product loss, Optima Pharma offers several special features. Occasionally, the components that have an impact are not the ones you would expect. An optimized transport system or a controlled laminar flow would be an example. Further features such as constant final dosing, greatly reduces product loss, which is especially important for valuable products.

Isolators are without a doubt the most secure barrier system. With catalytic ventilation, decontamination time is reduced by approximately 50%. For the first time, a company has published a study on an upgrade to an older isolater. The study confirms the enormous reduction in cycle time. Isolators are also very attractive for biopharmaceutical products and small batches.

In the area of pharmaceutical freeze-drying, there are also new approaches for significantly shortening drying times. One of the objectives here is selectively controlling the formation of crystallization cores; so-called “controlled nucleation”. New methods are in development. In current customer projects, Optima Pharma is already putting the technical requirements for this in place.

CP: How are biopharma packaging needs changing?

SS: Biopharmaceutical medications are often manufactured and packaged exclusively in small batches. Many of them are highly potent or toxic to cellular life, meaning that during the aseptic processing, the product and the operating personnel must be protected. At the same time, the medications are sensitive to shear forces and often have a limited shelf life in liquid form – hence the freeze-drying trend. Last but not least, biopharmaceutical medications are very expensive. This means that every drop is precious. All of these issues require solutions. In the previous question, several were addressed.

CP: What type of equipment is most in demand among clients?

SS: The modular, yet very flexible filling and sealing machines are also in high demand. Optima Pharma also conducts many projects, which include, in addition to filling and sealing, freeze-drying and isolator technology. This concept is also a great success.

CP: How is serialization impacting packaging equipment design and features?

SS: Serialization using data-matrix codes, for instance, is technically unproblematic in current pharmaceutical systems. The actual challenge, or the “know-how”, lies in data storage and in data management in particular. The exact requirements, however, are the result of the rest of the provisions, which differ from market to market. For example, the EU Falsified Medicines Directive will soon change the infrastructure required by manufacturing all the way to the pharmacy. The exact provisions are expected to be approved in the first quarter of 2016, after which an implementation period of three years is planned.

CP: What are some expectations for future packaging services and equipment?

SS: The technical diversity in machine building is growing, in the same way that development in biopharmaceutical medications will progress. If we also think about new areas such as personalized medicine and self-medication, which in our opinion will grow equally significantly, this leads to even more technical diversity.