Manufacturing Contract Services Archives - BioProcess InternationalBioProcess International

Investigation of HCP Enrichment During CGMP Scale-Up

by Kerry Wooding, Jacob Stubbs and Jared Isaac

On paper, scaling a bioprocess from a 10-L to a 100-L to a 2,000-L bioreactor may seem like a straightforward math problem that could be solved by software. In practice, however, the exercise relies on a complex set of biological, chemical, and engineering assumptions; on maintenance of healthy cell cultures; and on management of equipment and analytics while adjusting to each increase in scale (1). Process development and quality control groups need to monitor how scale-up might affect critical quality…

BioProcess Insider Interview: Dave Backer, Oxford Biomedica

by BPI Contributor

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: David Backer, Chief Commercial Officer, Oxford Biomedica. Early in 2022, Oxford Biomedica (OXB) purchased a majority stake in Homology Medicines. The companies have taken similar journeys, the primary difference being that they have worked with lentivirus (LV) and adenoassociated virus (AAV) vectors, respectively. Both companies started as drug developers and established manufacturing capacity to support internal products. Because of program attrition, OXB began offering its capabilities as a service. OXB now…

BioProcess Insider Interview: Jon Gunther, Just-Evotec Biologics

by BPI Contributor

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Jon Gunther, Head of Business Development, Just–Evotec Biologics. Evotec’s presence in the biopharmaceutical industry grew significantly with its May 2019 acquisition of Just Biotherapeutics. The combined company now provides integrated research and development (R&D) services and good manufacturing practice (GMP)-grade production processes for antibody (Ab) therapeutics. Just–Evotec already has established a manufacturing facility in Redmond, WA, and has initiated construction of a sister site in Toulouse, France, which should come online…

Partnering with a CDMO: Past the Service Offering

by BPI Contributor

Elie Hanania, PhD, vice president of process development for viral vector technologies, Avid Bioservices. Speaking as a representative of a global biopharmaceutical manufacturer, Hanania explored several considerations for identifying a suitable third-party manufacturer. Developers approach contract development/manufacturing organizations (CDMOs/CMOs) for different reasons. Biotechnology start-ups often lack internal capabilities for producing clinical-trial drug substance; thus, many such companies leverage CDMOs’ capacity and process-development expertise. Large, established pharmaceutical companies might work with contract partners to free up internal capacity for other products,…

How a Premier, Single-Source Platform Accelerates Biologic Drug Discovery and Innovation

by BPI Contributor

Jijie Gu, chief scientific officer, WuXi Biologics. WuXi Biologics has established itself as a contract research, development, and manufacturing organization (CRDMO) with comprehensive capabilities for multiple biopharmaceutical modalities. Gu presented on advances that his company has made in contract research for drug discovery. WuXi Biologics provides services for target evaluation, antibody generation, lead identification and optimization (LI and LO), developability study, and regulatory submission. The company leverages multiple platforms to accelerate LI, including an improved murine hybridoma technology with optimized…

Reflections on 20 Years: A Conversation with Yposkesi’s Chief Technical Officer

by Brian Mullan

Brian Mullan joined Yposkesi, an SK pharmteco company, as its chief technical officer in 2020. With over 20 years of experience, he has held leadership roles in late-phase process development, product launch, and commercial supply for large pharmaceutical companies making therapeutic monoclonal antibodies (MAbs). In eight years at Novartis, Mullan held posts as head of manufacturing science and technology and as a global technical project leader. From 2008 to 2012, he was process technology-transfer lead at Eli Lilly and Company.…

Global Excellence in Biomanufacturing: Fueled by 150 Years of Creating Value Sustainably

by Christiane Bardroff

Rentschler Biopharma began its role as a contract development and manufacturing organization (CDMO) for biopharmaceuticals in 1997. Founded in 1872 as a pharmacy in Laupheim, Germany, the company transitioned to pharmaceutical manufacturing, then branched out into biotechnology, and ultimately channeled its expertise and experience into becoming a global CDMO. Our success over the past 150 years has been based on a strong foundation of creating value sustainably, and that has paved the way for further advancement and success. As a…

Continuing Commitments to Quality Reflections on Contract Manufacturing Organizations and Success in the Biopharmaceutical Industry

by Nick Green

Nick Green has worked in the global pharmaceutical and healthcare-services industries for more than 35 years, including significant experience with third-party manufacturing of biological products. He currently serves as president and chief executive officer (CEO) of Avid Bioservices, a contract development and manufacturing organization (CDMO) that focuses on biopharmaceuticals derived from mammalian cell cultures. He has held senior leadership positions at several life-science companies. That includes time spent as president and CEO of Therapure Biopharma, Evolve Biologics, and Rhodia Pharma…

A Biotech Revolution

by Tony Hitchcock

To celebrate the 20th anniversary of BioProcess International, Tony Hitchcock (technical director at Charles River Laboratories) participated in a supplier survey on important bioprocess innovations, technologies, and advancements over the past two decades. He has over 38 years of experience in the biotechnology industry, specifically in production of critical starting materials and complex biologics for clinical trials. What is the most important bioprocessing innovation in the past 20 years? The emergence and adoption of single-use production systems has been important…

The Changing CDMO Landscape

by Dan Stanton

Contract development and manufacturing organizations (CDMOs) have evolved from simple service providers to full partners. Such companies now offer development and end-to-end services for highly complex biologics in a transition from contract manufacturing organizations (CMOs) and contract research organizations (CROs) to CDMOs. Before 2000, some drug companies (e.g., Merck, Novarits, Boehringer Ingelheim, and others) offered their excess manufacturing capacity to other drug makers. Chemical companies provided fill–finish and related services. Between 2000 and 2008, a number of dedicated CMOs emerged:…