Manufacturing Contract Services

Analytical Support for Biologics: A Conversation with Almac Sciences

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Almac Sciences (a member of the Almac Group) recently expanded its suite of analytical solutions to include biologics testing. This follows a 2019 expansion of the company’s facility in Athlone, Ireland, where it provides a comprehensive range of flexible pharmaceutical testing services to support drug development programs adhering to industry regulations and good manufacturing practice (GMP) standards. “Biologics have gained huge traction in the past decade and are poised for stronger growth in the coming years with potential to significantly…

December 17, 2020

Innovations in the Manufacturing of Cell and Gene Therapies

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Advancements in next-generation cell and gene therapies are fulfilling the promise of personalized medicine and attempting to cure and heal patients. Multiple approved products have been launched in global markets and the number of clinical trials continues to grow. Developing innovative advanced therapies is one of the biopharmaceutical industry’s greatest opportunities to dramatically improve patients’ lives. WuXi Advanced Therapies is a contract testing, development, and manufacturing organization (CTDMO) that has launched several innovative world-class platforms. It offers integrated platforms to…

December 3, 2020

Unraveling the Complexities of Technology Transfer

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In the biopharmaceutical industry, technology transfer refers to transfer of any process, together with its documentation and professional expertise, between development and manufacture or between manufacturing sites (1). This operation is common in the biopharmaceutical industry for a number of structural reasons. They include the dichotomy between small, innovation-based drug companies and large ones able to conduct late-phase clinical development and endowed with manufacturing capacity; the high capital cost of biopharmaceutical plants, which makes contract manufacturing attractive; and the need…

September 22, 2020

Developing Advanced-Therapy Products Through Global CDMOs

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Tremendous growth in the cell and gene therapy (CGT) industry is driving unprecedented demand for manufacturing services. To be sure, advanced-therapy developers increasingly are choosing to install in-house capabilities. Doing so can offer companies greater control of their processes, timelines, and budgets than they might have when outsourcing products (1). But industry experts agree that contract development and manufacturing organizations (CDMOs) will remain integral to CGT manufacturing and commercialization (1, 2), especially with veteran contract partners scrambling to acquire CGT…

September 22, 2020

Giving You the Power for Clinical and Commercial Success

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As a result of increased focus on customized medicine and continued emphasis on drug development for rare diseases, the biopharmaceutical industry continues to advance its methods for disease treatment by developing target-specific novel therapeutics. Formulations for these types of programs are complex and therefore present challenges in the design, scale-up, and manufacture of drug substances and drug products. Such challenges can delay getting critical products to patients. Contract development and manufacturing organizations (CDMOs) can help advance therapeutics and navigate production…

August 10, 2020

Sharing Viral Vector Expertise: A Conversation with Yposkesi’s Chief Executive Officer

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As a full-service contract development and manufacturing organization (CDMO) specializing in gene therapy development, Yposkesi produces recombinant adenoassociated virus (AAV) and lentivirus (LV) vectors using adherent-based and suspension-adapted cell expression platforms. Alain Lamproye joined the company as chief executive officer (CEO) in January 2017, having served previously as president of the biopharmaceutical business unit of Novasep (2012–2017) and as CEO of Henogen, its subsidiary dedicated to gene therapy. He has held managerial positions in pharmaceutical operations at Merck Serono (including…

May 24, 2020

Ask the Expert: Accelerating Development and Manufacturing Platforms for Viral Vectors

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Bai-wei Gu, Juan Lagos, and Matthew Weaver (heads of cell line development, upstream process development, and downstream process development groups, respectively, at WuXi Advanced Therapies, ATU) joined forces on 29 October 2019 to feature their company’s viral-vector manufacturing capabilities for cell and gene therapies. In addition to adherent platforms for lentivirus (LV) and adenoassociated virus (AAV) vectors, ATU soon will offer suspension-cultured viral vector platforms for them as well as analytical measures that support release testing. Transitioning from adherent to…

March 3, 2020

Supply and Demand Trends: Mammalian Biomanufacturing Industry Overview

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Since the 1986 approval of the first recombinant therapeutic antibody, OKT3, biopharmaceuticals have become a large percentage of overall pharmaceutical company revenue. In 2018, sales of the top five selling recombinant proteins — Humira (adalimumab, AbbVie), Keytruda (pembrolizumab, Merck), Herceptin (trastuzumab, Genentech), Enbrel (etanercept, Amgen), and Avastin (bevacizumab, Genentech), all antibodies — totaled over US$48 billion. The compound annual growth rate (CAGR) for antibodies revenue was about 20% from 2004 to 2014. Those products include naked monoclonal antibodies (MAbs), Fc-fusion…

February 7, 2020

Ask the Expert: Accelerating Timelines By Integrating Cell-Line Development and Manufacturing

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In a 31 October 2019 “Ask the Expert” presentation, Nicole Wakes (group leader of Abzena’s cell-line development team) observed that drug sponsors often outsource their early upstream activities to a few different contract research organizations (CROs). But that strategy can thwart short timelines and introduce regulatory and financial risks. Wakes described Abzena’s upstream approach, illustrating how partnering with a single, multicompetent CRO from cell line construction through manufacture can streamline workflows. Integrating cell line development and manufacturing in this way…

February 6, 2020

Ask the Expert: Developing Bioprocesses for Clinical Manufacturing Success

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Biopharmaceutical companies need to make critical chemistry, manufacturing, and controls (CMC) decisions during clinical development of recombinant protein biologics and advanced therapies. In a 17 December 2019 “Ask the Expert” webinar, Nigel Shipston (director of program design at FUJIFILM Diosynth Biotechnologies, FDB) reviewed key aspects of selecting and working with a contract development and manufacturing organization (CDMO). He also highlighted important factors that should be considered during early stages of process development. Shipston’s Presentation The sheer magnitude of investment required…

February 6, 2020