Contract Manufacturing, General

Oct 09, 2007
BioPharm International
By BioPharm International Editors
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.
Oct 09, 2007
BioPharm International
By BioPharm International Editors
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.
Aug 21, 2007
BioPharm International
By BioPharm International Editors
The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) issued a revised draft guidance on July 20 to help ensure that the safety, purity, and potency of biologics products is not compromised as a result of innovative, flexible manufacturing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.
Aug 01, 2007
BioPharm International
By BioPharm International Editors
Companies need to avoid operating in a manner that is inconsistent with the priorities established in the strategic sourcing decision.
Jul 01, 2007
BioPharm International
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.
Jun 02, 2007
BioPharm International
By BioPharm International Editors
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.
Jun 01, 2007
BioPharm International
Outsourcing has been a cornerstone of our industry for decades.
May 23, 2007
BioPharm International
By BioPharm International Editors
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.
May 01, 2007
BioPharm International
By BioPharm International Editors
By outsourcing high-end processes that demand advanced analytical and technical skills, biopharm companies are reaping substantial savings.
May 01, 2007
BioPharm International
Venture capital insiders say that the flow of funds into biopharma shouldcontinue, driven by the large amount of money available for investment.
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