Business

Uniting Small-Molecule and Biologic Drug Perspectives: Analytical Characterization and Regulatory Considerations for Antibody–Drug Conjugates

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Cosponsored by CASSS (an international separation science society) and the US Food and Drug Administration (FDA), the January 2010 CMC Strategy Forum explored antibody–drug conjugates (ADCs), which are monoclonal antibodies (MAbs) coupled to cytotoxic agents. The ADC platform of products is being used more and more for clinical evaluation in oncology. More than a dozen companies are developing several types, including products conjugated with calicheamicin, auristatins, and maytansinoids. Such products use the specificity of a MAb to deliver a cytotoxic…

September 23, 2015

Glycosylation of Therapeutic Proteins: Current Understanding of Structure–Function Relationships

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A CMC Strategy Forum held in Washington, DC, on Sunday 28 January 2007 focused on two topics related to protein structure and function (1). First, analytical techniques used in the glycan analysis characterization included recent advances and correlations among the various tools. And second, current understanding of glycosylation’s functional relevance to therapeutic proteins was discussed in the context of its effects on biological activity, pharmacokinetics, and Fc effector functions (for monoclonal antibodies, MAbs). Progress has been made in the field…

September 23, 2015

Analysis and Structure Characterization of Monoclonal Antibodies

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On 6 January 2003, 129 attendees participated in the second Well-Characterized Biotechnology Product (WCBP) Chemistry and Manufacturing Controls (CMC) strategy forum, titled “Analysis and Structure Characterization of Monoclonal Antibodies (MAbs),†held in San Francisco to discuss lot release and characterization test issues specific to MAbs (1). The objective of the meeting was twofold: to identify a “core†set of assays most useful for lot-release testing of MAbs and to define a mechanism for selecting appropriate potency tests. Two separate workshops…

September 23, 2015

Lot Release and Characterization Testing of Live-Virus–Based Vaccines and Gene Therapy Products

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The January 2005 CMC Strategy Forum was devoted to a discussion of live virus vaccines and viral vectors used for gene therapy. The purpose of the meeting was to determine whether consensus positions could be reached among the delegates regarding lot release, stability, characterization, and comparability testing. Part 1 of this two-part report on that meeting describes factors influencing the choices of lot-release assays for vaccines and gene-therapy products (1). Part 2 presents potency testing, characterization, and comparability studies, including…

September 23, 2015

Elucidation: The Medical Products Industry Must Resist the Pharmaphobes

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I often ask people: “Do you think medical practice is better, worse, or the same compared with what it was when I graduated from medical school nearly 50 years ago?†The most common answer is “I guess it’s somewhat better,†although some say “Worse!†I explain that the unequivocal right answer is “hugely better!†For example, our average lifespan is now a decade longer, and we suffer far less from incapacitating diseases such as arthritis. Then I ask, “Why are…

September 23, 2015

Manufacturing Strategies: BPI Theater @ Interphex 2015

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Bill Hartzel (director of strategic execution for advanced delivery technologies, Catalent Pharma) 1:30–1:55 pm Reducing the Risk Associated with the Filling of Biologics with Advanced Aseptic Processing  Hartzel discussed leveraging “blow–fill–seal†(BFS) aseptic processing technology to reduce risks associated with biologics fill and finish. A number of drug recalls have been associated with microbial and particulate contamination of glass vials, problems that could be solved using BFS. Automation eliminates human intervention at this critical stage, driving out associated risks. Hartzel…

August 24, 2015

Secondary Packaging: Creating Value with Product Lifecycle Management

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with Daniela Guttmann and Susanne Hall Increasing regulatory requirements combined with the market pressure to develop patient-friendly drug delivery systems make product lifecycle management (PLM) a decisive field for today’s pharmaceutical and biotechnology companies. Their strategic service providers also are affected by those conditions. For example, as an internationally operating contract development and manufacturing organization (CDMO), Vetter reports an increasing number of life-cycle management projects with its customers in the past years. Learn more in this white paper from Vetter.…

June 22, 2015

Challenges in Implementing Quality By Design: An Industry Perspective

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In the fall of 2004, the US Food and Drug Administration (FDA) published a final report entitled Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach (1). This publication set the groundwork for a prospective risk‑based approach to pharmaceutical product development. It was published on the heels of a November 2003 agreement between the FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to develop an internationally harmonized plan for developing…

June 16, 2015

Special Report: A World of Difference — Biosimilars and Biobetters Offer Unique Benefits — and Risks

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by John Otrompke, with Cheryl Scott and S. Anne Montgomery When the United States Food and Drug Administration (FDA) approved the country’s first ever biosimilar on 6 March 2015, it had been a long time coming. After all, the European Union had approved the first biosimilar in 2006, and a number of others have followed in Europe since then. Still, the approval of biosimilar filgrastim, a recombinant colony-stimulating factor used to offset the complications of chemotherapy, was a welcome step…

June 16, 2015

Paying for Pricey Medications: Debt Financing Options Could Provide a Solution

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In an era of US$1,000/dose medications, a new approach may be needed to finance an emerging breed of expensive but highly effective pharmaceuticals and vaccines, according to a new Rand Corporation analysis. In other industries, it is common for suppliers to encourage customer investment — particularly for costly capital purchases such as new automobiles and machinery — through approaches such as equipment leases or supplier-financed credit. The healthcare industry could learn from such approaches. For example, instead of paying up…

June 16, 2015