RALEIGH – More than 1,000 pharmaceutical manufacturing leaders gathered at the Raleigh Convention Center Tuesday focused on cutting-edge technologies designed to improve the delivery of drugs to patients with life-threatening illnesses. The 25th Annual Life Sciences and Technology Conference, presented by ISPE-CaSA (International Society for Pharmaceutical Engineering – Carolina-South Atlantic Chapter), explores the future of manufacturing technologies, automation, reliability and pharma facilities.
During the keynote address, Paul McKenzie, Ph.D., executive vice president at Biogen, talked about overall production advances and supply-chain transparency over the last two decades. Biologics manufacturing is experiencing greater efficiency than ever before – touting product outputs of 10g per liter or better. This increased output results in lower production costs and improved quality control for companies producing at these levels. McKenzie handles global manufacturing and operations of the company’s advanced biologics manufacturing facility in Solothurn, Switzerland.
Biogen is also heavily vested in ASO (Antisense Oligonucleotide) pharmaceuticals. It is a newer line of medicine–based therapies that deliver modified RNA to restore or alter genes that function incorrectly. The manufacturing of these life-saving medications rests on multiple issues – one identified is the safe use of solvents in the splicing process. These solvents can be flammable, corrosive and toxic. Facilities involved in ASO production require additional handling protocols, safety equipment and disposal planning.
Deadlines forthcoming for Regulation Compliance
Pharmaceutical manufacturers have nine months remaining to become fully compliant with the 2013 U.S. Drug Supply-Chain Security Act passed during the Obama administration. A pharmaceutical and medical device counterfeit and fraud expert, Lars Olsen discussed the regulatory requirements for serialization and gave insights on the latest packaging trends. Olsen, a global technology partner within assembly and packaging at NNE, says the largest change in packaging will be the ability to track each step of the distribution chain from the manufacturer to the patient. The FDA-enforced U.S. laws take effect Nov. 27, 2018.
During a one-on-one with Olsen, he shared details on what is involved in the package-labeling process known as serialization. In short, serialization is the use of a 2D barcode on pharmaceutical products and establishing a documented chain of custody from the consumer back to the manufacturer. This process is important for medical forensics, as well as government oversight of pharmaceutical distribution. The code contains a unique sales unit ID, aka serial number, in addition to the national product code, lot number, expiration date, as well as other identifiers as required.
“Eighty percent of product recalls from the market are due to packaging errors,” says Olsen. While increased supply-chain tracking may be beneficial for enforcement agencies and consumer safety, it comes with some real costs and challenges to the industry.
The first challenge is upfit. According to Olsen, it costs between $1 and $1.5 million to add serialization to a production line. From an industry expense standpoint, in Europe alone, there are an estimated 22-25,000 pharmaceutical packaging production lines. The cost of this change will need to come from somewhere.
The second challenge is a lack of universal standards. The U.S. FDA requirements are not a match for the EU requirements, and the EU allows the individual member countries to set their own standards, not to mention hundreds of other countries in the world. There is no consistent tracking methodology in the information, barcode type, or chain of custody procedures.
This leads to the biggest challenge, corporate integration. Olsen offers that many companies that are attempting to comply treat serialization as a project that just affects the packaging division, as opposed to a change in the management of operations as a whole.
“Twenty to 25 percent of operational costs is simple product packaging,” says Olsen. “The OEE (overall equipment effectiveness) in the pharmaceutical industry runs between 40-60 percent. The addition of serialization can reduce efficiency by as much as 5 percent. This can be a financial game changer for the manufacturer, even big pharma.”
Manufacturer-led solutions to these challenges are emerging, but need time to prove themselves. Manufacturers have been trying to maximize order size by introducing multi-market packaging. However, this will be a challenge with the future diversity in serialization legislation. An increase in SKUs (Stock Keeping Units) must be anticipated and incorporated into packaging strategies and needs to be mitigated by efficient handling of small-size batches.
Olsen emphasizes that training on all level of operation is required to minimize human errors. Introducing serialization means that you push GMP compliance from the batch/lot level down to the individual sales/shipping unit level.
Olsen will be repeating his presentation via a free webinar on April 10 at 9 a.m. (EST).
While the pharmaceutical manufacturing industry is facing some significant challenges, companies are reacting with additional specialization. Organizations like ISPE are producing guidelines, best practices and education programs to meet the challenges of today’s world of medicine. In addition, process and facility engineers, as well as equipment manufacturers are upping their game to help solve these problems. With the greater Triangle area ranked the 8th largest biopharma cluster in the U.S. according to GEN, these changes in the industry will help fuel economic growth in the region and across N.C.