Manufacturing Contract Services

Biologics Manufacturing Without the Big Bioreactors

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Over the past few decades, the biotechnology industry has brought to patients a medical revolution with the most advanced medicine ever seen. Yet much of the world’s population cannot afford or get access to these breakthrough therapeutics. That is in part a consequence of the high associated costs of development and biomanufacturing, extended times for regulatory review and approval, and a lack of regional manufacturing and dependable supply chains (because of facility costs and a scarcity of expertise). The recent…

June 21, 2022

eBook: Biopharmaceutical Outsourcing — Capacities, Companies, and Current Trends

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Although many biopharmaceutical companies leverage in-house capabilities to produce their therapies, contract manufacturing partners represent a significant part of the biologics industry. Recent capacity investments, facility expansions, and mergers and acquisitions (M&A) activity even suggest that third-party biologics production is gaining traction. In this eBook, BioProcess Insider’s founding editor, Dan Stanton, takes the pulse of today’s outsourcing sector. First, he speaks with Dawn Ecker (director of bioTRAK database services at BDO) to establish what kinds of companies are amassing mammalian…

May 23, 2022

Bench to Bedside: Why Successful Drug Development Requires a Team Approach

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The process from drug development to market approval takes many years and requires both integration and orchestration of several activities based on deep scientific and commercial expertise. We tend to think of drug development as a sequential, phase-driven process during which a product is taken methodically from discovery through preclinical studies, clinical development, and ultimately commercial launch. In reality, development of new drugs is not linear; rather, it requires integrated coordination between collaborators from different functions and stakeholders — from…

February 11, 2022

In Search of a CMO for My Biotechnology Startup: How to Navigate a Journey Without Process Maps

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An innovative biopharmaceutical product can transform from an abstract idea at small scale into the basis of a burgeoning startup company. At that point, company leaders seek ways to ensure that a biologic will scale up in a quality-controlled, professional, and sustainable environment. That involves refining a research-stage prototype into a product that will be consistent and reproducible for research and development (R&D) and manufacturing and that will meet all relevant regulatory standards in specified target markets. Within the constraints…

February 4, 2022

Facilitating Workforce Development: A case study on improving single-use training through vendor and end-user collaboration

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Discover how Pall Corporation and Lonza collaborated to improve single-use technology training for operators using a blended approach to learning. This article presents: The importance of SUT training for operators. Why a blended approach ensures that operators get the training they need in the format that best suits their learning style. How collaboration between suppliers and biomanufacturers can shorten training program development timelines and increase the quality of training tools. How Pall and Lonza developed a digital training approach together.…

January 27, 2022

Finding the Right Partner for Outsourced Cell-Line Development

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The successful commercialization of a biopharmaceutical product begins with a robust and productive cell line. Inefficient cell-line development (CLD) can lead to costly delays and roadblocks. For that reason, small, new, and virtual companies — and even established and mid-size companies — often seek the support of outsourcing partners to develop their cell lines. Outsourcing CLD activities can ease many pressures associated with manufacturing new biotherapeutics. The benefits of outsourcing CLD and associated processes include access to specialized expertise and…

December 8, 2021

28 Years of Experience Developing and Manufacturing Biopharmaceuticals

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Avid Bioservices, Inc. is a full-service, dedicated contract development and manufacturing organization (CDMO) focused on biopharmaceutical drug substances derived from mammalian cell culture. Avid’s services include process development and current good manufacturing practice (CGMP) clinical and commercial drug-substance manufacturing, bulk packaging, release and stability testing, and regulatory submissions support. For early stage programs, the company provides process development activities such as upstream and downstream development and optimization, pilot-scale manufacturing, analytical methods development, and testing and characterization. Avid has 28 years…

August 27, 2021

Partnering with Innovators: From Raw Materials to Commercial-Ready Processes

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Advancements in life sciences technologies and the increasing demands for improved, effective, and innovative products to prevent, treat, and in some cases, cure diseases have focused the attention of drug developers on new modalities such as mRNA-, DNA-, viral vector-, and cell-based therapies and vaccines. Novel biopharmaceutical products bring a level of complexity to developing and bringing them through design, clinical studies, and to the market. Like traditional drug products, complex therapies require robust, scalable manufacturing processes, a reliable quality-driven…

August 27, 2021

Biopharmaceutical Development and CGMP Manufacturing: Expansion of Capacities for Clinical and Commercial Supply

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Richter-Helm BioLogics is a leading and steadily growing contract manufacturer based in Germany. We comply with good manufacturing practice (GMP) and specialize in microbial biopharmaceutical products. Our work focuses on recombinant proteins, plasmid DNA, antibody fragments, and vaccines. Clients worldwide already have benefited from our commitment to GMP, flexibility, and total transparency. With a proven 30-year track record and highly skilled professionals, Richter-Helm supports you with process development, supply of products for clinical trials, commercial production, in-house quality control (QC)…

August 27, 2021

Facility Design:
A Guide to Maximizing Value

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Rapid growth and changing market dynamics in biologics and vaccine sectors have prompted biopharmaceutical companies and contract development and manufacturing organizations (CDMOs) to build new manufacturing facilities at unprecedented speeds. This often means developing single-use (SU) or hybrid bioprocessing facilities with reusable legacy equipment for production of monoclonal antibodies (MAbs), antibody–drug conjugates (ADCs), and viral-based vectors. For many companies, facility design begins by engaging an engineering consultancy to develop a layout that maximizes space use and minimizes equipment, fittings, and…

May 21, 2021