Search results for " drug"
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The New World of Biopharmaceutical Manufacturing
Companies are implementing end-to-end single-use platforms for monoclonal antibody, antibody drug conjugate, and vaccine production. Flexible facilities are likely to become an important part of large…
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Being Thorough When Transferring Technology
During tech transfer, methods, skills, technologies, and importantly, knowledge is transferred from the drug developer to another site or group, often a contract manufacturing organization (CMO). It’s…
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The Tide Stays High
… expectation that the regulatory environment will be less restrictive and FDA will be approving more drugs more quickly. There have even been suggestions that a venture capitalist might be appointed …
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Innovation vs. Capacity: How CMOs Compete
The contract and manufacturing organization (CMO) industry can be segmented along obvious lines such as API versus drug product manufacturers, biologics versus small molecule, dose form(s) manufacture…
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FDA Approves First Biosimilar
The approval trails a unanimous positive vote in January 2015 from FDA’s Oncologic Drugs Advisory Committee. To date, there are a total of five 351(k) applications that are publicly disclosed, includi…
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Securing the Single-Use Supply Chain
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technology has increased, the adoption of disposable equipment for commercial manufacturing…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Continuum of CQAs
Prior to the development of a new drug, companies frequently decide and document a therapeutic need in the marketplace for a new pharmaceutical. It is through this effort that th…
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Elucidating Biosimilars Characterization
…ulatory strategy, Biosimilars Strategic Unit; Colin Vose, PhD, vice-president, Centre for Integrated Drug Development; Doris Weilert, PhD, senior research pharmacokineticist, Early Clinical Developme…
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Biosimilars Development and Supply: How Complex Can the Process Be?
A typical biologic development route includes: preclinical discovery and validation of target; clinical development; drug approval, launch, and commercialization. During preclinical and early clinical…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Appropriate control of CQAs is a common review concern for both investigational new drug (IND) and license applications.6,7 Product quality characteristics encompass a wide variety of product variants…