Outsourcing Articles

CMC Biopharmaceuticals A/S, a Copenhagen, Denmark-based provider of contract biomanufacturing services, has acquired the biologics development and manufacturing operation that Eli Lilly and Company gained when it purchased ICOS Corporation in January 2007. The operation, which will be known as CMC ICOS Biologics Inc., is located in Bothell, WA, and is responsible for developing and manufacturing therapeutic proteins for early clinical trials. The financial terms of the deal were not disclosed.

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Stability optimization of a drug product is commonly only considered during the drug development phase. The decision to package a product in a vial or a syringe is typically made in the early phases of drug development and testing and is based on allowing for ultimate flexibility for the clinical site. The stability of the drug product with the container is tested throughout the drug development life cycle but, again, is typically only performed on a container that allows the ultimate flexibility in dosing and administration at the clinical site.

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The analysis of biological samples for drugs and their metabolites in a regulated environment is an integral part of nearly every drug development program. The toxicological and clinical programs that require bioanalytical support are critical to establishing the drug's safety and efficacy, and can involve many thousands of analyses spanning multiple species, studies and years. In a pharmaceutical R&D environment, where multiple drugs are in various stages of development, management of the logistics, costs and science involved with this process can be a complex task. Outsourcing bioanalytical work to contract research organizations (CROs) while adding another level of complexity to managing drug development, has become an essential strategy for pharmaceutical companies. Deciding when, where and what to outsource is a multifaceted exercise. An assessment of the factors affecting the decision to outsource is an important step in initiating or improving such outsourcing strategies.

Across the globe, companies spend anywhere from 40% to 50% of every logistics dollar on third party logistics (3PL) services.1 The opportunity to reduce this spend is a priority for organizations that are trying to drive down operational costs and increase their bottom line. However, for pharmaceutical and biotechnology firms, selecting a 3PL provider isn't as simple as comparing costs. It requires a careful examination of a vendor's credentials, capabilities, business practices, technology and track record for safely storing, handling and distributing valuable pharmaceutical products. Just because a 3PL provider has experience transporting and handling books, CDs or food products, does not mean it is adequately equipped to contend with both deliberate and accidental threats commonly encountered in the global pharmaceutical supply chain.

The safe manufacture of potent active pharmaceutical ingredients (APIs) and products containing these APIs requires both "hardware" -- facility features, modern equipment and engineering controls -- and "software" -- programs, practices and procedures -- to adequately protect personnel and the environment. When outsourcing pharmaceutical production to third party contract manufacturing organizations (CMOs), their technical capability to meet clinical or commercial requirements is only one aspect that needs to be evaluated. There is also a need to ensure, with the same rigor, that these CMOs are capable of safely handling potent APIs and products.

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The pharmaceutical industry, which is generally associated with precision and quality control, has in reality failed to keep up with other industries in terms of manufacturing efficiency and productivity, largely because of the cost and burden involved in revalidating any process changed in the spirit of improvement. Once manufacturers confirm or validate their processes as compliant, they traditionally have been very reticent to change them. The simple fact is that pharmaceutical manufacturers, which historically have enjoyed consistently robust profit margins, have had little economic incentive to introduce change.

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In an atmosphere of declining R&D productivity, mounting pricing pressure and changing regulatory requirements, pharmaceutical and life sciences companies face increasing challenges to achieve and maintain profitable growth and innovation. Pharmaceutical outsourcing offers companies one of the strongest opportunities to address these challenges, allowing companies to focus limited resources on the highest-return business initiatives, to access specialized expertise, to achieve cost-saving benefits and to reduce burn rates that lead directly to greater shareholder value.

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Wyeth has suffered some high-profile FDA setbacks in recent months, but the company remains committed to a radical R&D  model implemented earlier this decade. With this new structure yielding a minimum of eight INDs annually, Wyeth faced the challenge of efficiently handling clinical trials for all these new compounds.

We recently caught up with Robert Maguire, M.D., Wyeth's vice president, chief of operations for clinical R&D, to discuss the company's approach to global clinical trials, its position on "exclusivity" with clinical sites, the learning curves for clinical operations in emerging regions, the company's approach to innovation, and the development of its Early Clinical Development Center (ECDC)  network.

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The objective of formulation development sounds simple enough to a layman: Put an active pharmaceutical agent into a platform that can be properly delivered for therapeutic value. But from the point of view of formulators and pharma companies, this process is anything but simple. Pressure to fill pipelines and get product to market quickly can take their toll on formulation development, as pharmaceutical companies -- particularly smaller firms that are struggling to get their feet on the ground -- try to hurry through the formulation development process. This can often lead to finger pointing, disappointment and risk.

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AstraZeneca is in full-on spin control mode following a potentially tarnishing interview that asserted the pharmaceutical giant was getting out of the drug-making business. According the September 17 edition of The Times of London ran an article titled "AstraZeneca to outsource manufacturing," which featured a key quote from Dave Smith, AstraZeneca's executive vice president of operations, which sent shock waves through the industry: "Manufacturing for AstraZeneca is not a core activity."

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