Interest in biosimilar protein drugs continues to grow, and pharmaceutical manufacturers are racing to patent new drug formulations in order to survive in an evolving market.  

Biosimilars are receiving a lot of attention due to the perceived cost-savings that consumers hope to gain and opportunities for alternative pharmaceutical manufacturers to enter both established and emerging markets. The characteristic protein makeup of biosimilars, however, requires strict and careful manufacturing practices in order to maintain safety and satisfy U.S. Food and Drug Administration (FDA) regulations, all while yielding a return on investment.

Pharmaceutical manufacturers must prepare themselves for some of the challenges that lie ahead for the biosimilars market. To help the industry avoid pitfalls, we spoke with two industry experts to weigh in on the important challenges pharmaceutical companies can anticipate in the manufacturing and packaging of biosimilars.

Know the Challenges of Biosimilar Manufacturing


Dr. Michiel Ultee, Principal, Ulteemit BioConsulting, LLC

A major payoff of investing in biosimilar manufacturing is that you can get to market faster than a new innovator biopharmaceutical. Some friendly advice would be to start three to five years before a patent expires. A biosimilar manufacturer will also want to purchase large quantities of the innovator product because they will need various samples of different batches to truly understand the range of allowed variability in analytical properties. Having a strong analytical system will also be paramount in determining the characterization of the biosimilar; for example, quality mass spectrometer and electrophoresis instrumentation for structure and glycoform testing. 

In order to compete on price, biosimilar manufacturers should select a cell line with high specific productivity as well as the ability to grow to high cell densities, thereby yielding the highest amount or titer in each bioreactor run. In addition to these cell-line features, biosimilar manufacturers will want to develop an efficient downstream process to purify the biosimilar from the crude cell harvest. A robust cold chain is needed as well to handle the bulk drug and drug product because of the temperature sensitivities of biological products. This includes investment in temperature monitors to ensure that products maintain ultra-cold temperatures. Lastly, biosimilar manufacturers may want to consider packaging innovations because this is an area where the FDA allows some latitude. For example, an innovator drug that is stored in a vial could instead be packaged in a pre-filled syringe, resulting in greater convenience and reduced agitation of the protein solution during shipping and handling. 

Opportunities for Additional Industry Insight

In tackling these challenges, biosimilar manufacturers specifically can benefit from the opportunities to find a wide range of manufacturing and supply chain solutions, educational programming and networking opportunities at Healthcare Packaging EXPO, co-located with PACK EXPO Las Vegas (Las Vegas Convention Center; Sept. 25—27). Produced by PMMI, the Association for Packaging and Processing Technologies, the Healthcare Packaging EXPO will house 250 exhibitors showcasing solutions in cleaning and sterilisation, controls and robotics, dosing, packaging, processing, tamper-proof packaging, supply chain services, automation and cold chain logistics. Attendees can also take advantage of the Innovation Stage, which provides free and convenient, on-floor access to a series of 30-minute seminars hosted by industry experts. 

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