Q&A withVince Santa Maria, president of Bilcare Global Clinical Supplies, Americas
Do you see a new industry trend emerging?
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.
Another trend in the industry is that, out of a desire for faster timelines and lower cost, companies are putting APIs directly
into capsules and circumventing the need for a formulation-development process on unproven molecules.
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.
What is the biggest industry challenge you're now facing?
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
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
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.