Pharma Capsules

Milestones

Cambridge Major Receives Fine Chemicals Award

Cambridge Major Laboratories (CML, Germantown, WI) received the 2008 Frost and Sullivan Industry Best Practices Award for business excellence and sustainability. CML competed with several North American fine-chemical companies for the award. The selection process entailed months of interviews and analysis of business practices and performance.

Frost and Sullivan said that CML's key success factors included customer diversity, a strong management team, a large portfolio of preclinical projects with a high percent of graduation into the clinical stage, timely execution of projects, and a service-oriented culture, according to a CML press release.

Ross Appoints New Vice-President

Charles Ross and Son (Hauppauge, NY) promoted John Paterson to the position of vice-president of Ross Mixing, which is located in Port St. Lucie, Florida. Paterson joined Ross as product manager of coatings equipment in 1995. In 1996 he was promoted to general manager of Ross Mixing.

In his new position, Paterson will handle general management duties at the company's Port St. Lucie plant. He will also oversee Ross's continuing development of specialty mixing and dispersion equipment for the coatings industry.

Paterson holds two design patents: one for a basket mill and one for Ross's "PreMax" high-speed mixer.

Meissner Opens Italian Branch

Meissner (Camarillo, CA) opened a new branch office in Pavia, Italy, to better serve the European marketplace. The Italian office will collaborate with Meissner's German office, which has been operating successfully for more than three years.

Meissner manufactures advanced microfiltration products, including single-use biocontainer and fluid-path assemblies, for the sterilization of drugs, reagents, and other critical biomanufacturing and pharmaceutical applications. The company provides validation services, documentation, and customer support to optimize filtration systems.

Lancaster Aids Compliance with Harmonized Methods

Lancaster Laboratories (Lancaster, PA) is providing technical and regulatory expertise to help the pharmaceutical industry comply with the new Harmonized Microbial Limits methods. The new methods for microbial-enumeration tests and tests for specified microorganisms will be required beginning Apr. 1, 2009, for the Japanese Pharmacopoeia methods (4.05) and May 1, 2009, for the US Pharmacopeia methods (<61> and <62>).

"We've been offering the harmonized methods for two years and have completed more than 200 product validations for more than 50 different clients," said Mike Yunginger, manager of nonsterile products at Lancaster Laboratories, in a company press release.

Q&A:

Marcelo Morales, chief executive officer of HollisterStier Laboratories and Draxis Pharma Contract Manufacturing

PharmTech:

Do you see a new trend emerging in the pharmaceutical industry?

Marcelo Morales, CEO of HollisterStier

Morales:

The trends that we are excited about involve innovative drug-delivery mechanisms. Drug-delivery technologies are improving, and their application is becoming broader. More molecules and drugs are becoming candidates for these delivery mechanisms than before. The benefits of these drug-delivery mechanisms include high patient uptake and compliance, safety, and patient comfort.

We're focusing energies on determining which delivery mechanisms are most appropriate for us to invest in. Prefilled injection devices such as canisters, pens, and syringes are innovative and are creating a trend. As a contract manufacturer, we should stay ahead of these technologies so that we are ready to provide services to clients who are looking to use those methods.

PharmTech:

What is the most common demand your clients are currently making of you?

Morales:

Flexibility, responsiveness, and innovation. Flexibility means working with clients amid changes in factors such as patient demand or economic pressures. For us, flexibility is the ability to adjust our production schedule accordingly to meet our clients' changing needs. Infusing Six Sigma and Lean manufacturing methodologies into our corporate culture plays a significant role in enabling that flexibility.

Responsiveness is a function of the times. Three or four years ago, clients would plan out manufacturing activity several years in advance, and contract manufacturers were able to schedule accordingly. Today, clients are asking for shorter lead times, meaning that the expectation to be responsive is greater. Strategically, we've focused on product management and business development to be highly responsive.

Finally, clients are demanding innovative methods for lyophilization and filling capabilities. We have invested considerable energy in adopting lyophilization cooling capabilities, flexible filling suites, and streamlined clinical-trial processing to meet many of these demands. We realize that there is an ongoing need to incorporate innovative techniques into our systems and services.