Contract Manufacturing, General

Lonza's bid for Patheon makes the contract manufacturing industry re-examine the one-stop manufacturer model.

To select the right partner for media design and optimization services, several key factors must be considered.

How to ensure smooth technology transfers.

There could be a serious glut of commercial scale mammalian cell culture capacity over the next five years. Then again, there could be a significant shortage. It all depends on how things develop in expression technology, the new product pipeline, and corporate strategies.

If Indian biologics manufacturers can establish a track record for recombinant products, enhance quality image, maintain cost competitiveness, and demonstrate technology transfer and regulatory knowhow, they are likely to be in the middle of the next boom in biologics manufacturing.

The current overcapacity situation in the bio/pharmaceutical industry is a reminder that CMOs need to come up with business models and value propositions that are based on more than just selling capacity.

There are several considerations to keep in mind when auditing an outsourcing provider.

The outsourced service provider should be considered an extension of your own laboratory.

After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a provider and preparing quality agreements.

When a biopharmaceutical company pursues an outsourcing strategy, the choice of a contractor is a critical and strategic decision.

Cobra Biomanufacturing is an international full-service manufacturer of biopharmaceuticals, dedicated to designing robust processes that deliver biopharmaceutical products to its life sciences customers for preclinical through Phase 3 studies.

Discovery Laboratories (Warrington, PA) could see the end of its struggle to launch its Surfaxin (lucinactant) drug on the US market soon, as the manufacturing issues it has faced have been resolved.

The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) issued a revised draft guidance on July 20 to help ensure that the safety, purity, and potency of biologics products is not compromised as a result of innovative, flexible manufacturing arrangements.

Companies need to avoid operating in a manner that is inconsistent with the priorities established in the strategic sourcing decision.

The BIO annual meeting in early May had an upbeat tone. Investment capital is flowing into the industry at high levels, resulting in strong demand for contract development services. The funding stream is particularly strong in the US, and that is attracting more European contract manufacturers (CMOs) eager to improve business development here.

Biologics manufacturing is a technologically complex, highly regulated process. In comparison to small-molecule manufacturing, biologics manufacturing requires far more planning, investment, and skilled personnel and, therefore, can be much riskier. For biotech companies requiring such manufacturing capabilities and experience, partnering with a biologics-focused contract manufacturing organization (CMO) can be a good solution.

Outsourcing has been a cornerstone of our industry for decades.

Eden Biodesign (Liverpool, UK, www.edenbiodesign.com), SAFC (St. Louis, MO, www.sigmaaldrich.com/SAFC/Pharma), Midatech Group (Oxfordshire, OX, www.midatechgroup.com), Cellexus Systems (Cambridgeshire, UK, www.cellexusbiosystems.com), and BioConvergence LLC (Bloomington, IN, www.bioc.us) are sprucing up their product development and services with the construction of new manufacturing facilities.

Venture capital insiders say that the flow of funds into biopharma shouldcontinue, driven by the large amount of money available for investment.

By outsourcing high-end processes that demand advanced analytical and technical skills, biopharm companies are reaping substantial savings.

Partnering with a surging number of CROs, CMOs, CSOs, and other niche providers, biopharm companies in 2007 will have an estimated spend of more than $7 billion on international clinical trial outsourcing alone.

Consider the number of patients, the dose each will receive (and how this dose is calculated), the number of doses per patient, and what overage is needed to allow for vial breakage.

The greatest benefits of outsourcing are realized when a company takes a strategic approach rather than a tactical approach.

The contract manufacturer must have sufficient capacity so it can absorb possible surge in demand, and back-up capability in case of a power failure or other event.

The three largest players have accumulated, or are in the process of accumulating, nearly a million liters of capacity between them.

The changes in biologics manufacturing regulations contained in the 1997 FDA Modernization Act significantly bolstered the growth of CMOs.

In the rush to save money, the consequences of potential problems often are ignored.

A major shift is occurring in the way the biopharmaceutical industry sources goods and services. Price pressures at the retail end of the value chain and a difficult fundraising environment are forcing biopharmaceutical companies to take greater control of their costs. Purchased goods and services, including contract research and manufacturing services as well as raw materials and laboratory supplies, are a major expense in most companies, so control of those purchasing decisions is coming in for special scrutiny.

The lack of biomanufacturer acquisitions seems surprising.

Interestingly, it is companies that already have the most capacity available to them that are building even more.