Q&A withVince Santa Maria, president of Bilcare Global Clinical Supplies, Americas

Santa Maria:
We see several new industry trends emerging. First, the potency of marketed compounds is increasing. The typical dosage strength 10 years ago was a few hundred milligrams. Now it is more common to have single milligram or microgram levels per dose. This dosage strength creates challenges; it is difficult to formulate and develop smaller dosage units and ensure that the bulk material is uniform with respect to the active pharmaceutical ingredient (API). We also need to look closely at employee health because highly potent compounds pose great threats to worker safety if they are not handled properly.

The opening of new markets because of the need for large and untapped patient populations challenges the regulatory processes' ability to ensure the stability of those populations and trials. I think we need to consider the increased regulatory focus on ePedigree authentication of clinical trial materials. Anticounterfeiting and consumer and patient safety are big concerns.

PharmTech:
What is the biggest industry challenge you're now facing?

Santa Maria:
Our biggest current challenge is the uncertainty in the global marketplace, specifically, what's going to happen with pharmaceutical companies. Our goal is to stay in a constant state of readiness so that we can respond quickly when our customers finalize their business models and adjust their outsourcing needs.

The industry will more than likely continue to see more clinical trials that exceed captive capacity; mounting regulatory pressures that increase the number, size, and globalization of clinical trials; consolidation of pharmaceutical companies that are decreasing their internal capacity; and the growth of emerging sectors such as biotechnology and specialty pharmaceuticals. Pharmaceutical companies are focused on getting their products to market faster with less infrastructure and fewer internal resources.

Milestones

Catalent Supports Swine-Flu Response

Catalent Pharma Solutions (Somerset, NJ) a provider of outsourced dosage-form manufacturing and packaging services to the pharmaceutical and biotechnology industries, pledges to support the industries' response to the expanding swine influenza (H1N1) outbreak.

Catalent has existing customer agreements to produce on demand substantial additional commercial supplies for antiviral drugs currently recommended by the US Centers for Disease Control and Prevention to treat H1N1-type flu. Catalent also provides prefilled-syringe filling for seasonal influenza vaccines at its recently opened Brussels, Belgium, facility. The company is preparing to deploy additional capacity for the multiple H1N1 flu vaccines that its customers are currently developing. Catalent also is providing clinical support for several influenza-treatment compounds currently in development.

CapsCanada Acquires Two Production Facilities

CapsCanada acquired two additional gelatin production facilities. The acquisition further consolidates the company's vertically integrated operations and gives it a total of four bovine-hide gelatin-production facilities. CapsCanada is a world leader in the manufacturing of pharmaceutical-grade hard capsules.

"We have experienced very strong demand, in part due to the fact that the most prestigious companies prefer bovine-hide gelatin," said Gabriel Eilemberg, the company's director of business development, in a press release. Eilemberg added that CapsCanada is the only vertically integrated capsule manufacturer. Vertical integration enables the company to provide "a secure long-term supply, better traceability, and superior quality," he said.

Schreiner Develops Package for Bayer

Bayer Healthcare commissioned Schreiner MediPharm (Oberschlei heim, Germany) to develop a specialty security seal for its Levitra (vardenafil) product. Bayer required a closure seal that was easy to handle and could be used to close the packaging again several times. The company also wanted a seal to provide clearly visible proof-of-first-opening and not be nondestructively detachable from the substrate.

Schreiner developed a tailor-made wallet seal that incorporates a starter tab and an individual void effect. The seal uses a special adhesive adapted exactly to the solution and the substrate. The nonadhesive starter tab facilitates opening the package and lifts the void seal area from the substrate. This design allows the wallet to be resealed multiple times. When the seal is opened for the first time, the void message "Open" appears. The message has a different color than the seal and remains permanently visible. To prevent undetected removal of the seal, the rear area of the seal is affixed to the cardboard packaging with a special, permanent adhesive. Any attempt to peel off the seal causes irreversible damage to the packaging.