Manufacturing Contract Services

A Multistep Research Protocol to Develop and Implement Validated Guidelines for CMO RFI and RFP Processes: Biopharmaceutical Vendor Evaluation and Selection Minimum Standards (BioVesel)

Pursuant to the proposal for validated minimum standards for biopharmaceutical contract manufacturing organization (CMO) request-for-information (RFI) and request-for-proposal (RFP) processes (biopharmaceutical vendor evaluation and selection minimum standards, BioVesel) (1), we propose herein a multistep research protocol to develop and implement the BioVesel standards. This proposal is intended as a basis for discussion among mulitple stakeholders. Detailed research protocols for each proposed stage in the development and implementation of BioVesel will be drafted and published separately. The context of the proposed…

Proposing a Systematic QbD Approach Toward Validated Guidelines for CMO RFI and RFP Processes: Biopharmaceutical Vendor Evaluation and Selection Minimum Standards (BioVesel)

Three major concerns predominate biotechnology executive management in organizations of all sizes and above all other risks: finance (or its absence at critical moments), technological performance, and failures in coordination. Some business functions, such as human resources (HR), are effectively siloed horizontally and therein are more likely to be susceptible to only one of those risks (1). Few functions are subject to this trinity of risks simultaneously; all functions may be exposed to failures in internal coordination, and a smaller…

Worldwide Biopharmaceutical Manufacturing Capacity Analysis: Growth Continues Across the Board

While the growth in biopharmaceutical manufacturing capacity in developed, major market countries is continuing its slow and steady climb, developing regions often are seeing double that growth rate. Over the past eight years, as detailed in the “About the Data” box, our company’s index of the top 1,000 biomanufacturing facilities (1) has tracked and ranked bioprocessing facilities worldwide in terms of known or estimated bioprocessing capacity (cumulative onsite bioreactor volume) number of biological products manufactured at clinical scale commercial scale…

Seamless Transition from R&D to Manufacturing

Fast and cheap: These criteria are becoming ever more urgent drivers for manufacturers of biologics, faced with increased scrutiny on the costs of developing novel drugs, the lengthy timelines for delivering these drugs to patients, and the tightening competition to capitalize on new targets. The challenge for manufacturers is further heightened by the expectations to deliver on quality as well. Although development and production of molecules such as monoclonal antibodies (MAbs) have greatly benefited from the “platformization” of core technologies…

Emerging Technologies and Strategies to Accelerate Process Development and Time to Market

Gustavo Mahler, president and chief executive officer, AGC Biologics AGC Biologics is one of the largest global biologics contract development and manufacturing organizations (CDMO) specializing in clinical and commercial development of therapeutic proteins. It has developed more than 200 products, both mammalian and microbial, from preclinical to commercial on all scales. The company’s CGMP facilities are located in the United States, Europe, and Japan. AGC Biologics’s technologies and strategies to accelerate time to market include standardized cell-line and cell-bank creation…

Future-Proofing and Understanding Your Molecule with Contemporary Analytics and Formulation Approaches

Greg Adams, senior director of global analytical strategy and development, Fujifilm Diosynth Biotechnologies (FDB) “Proteins have personalities.” Adams began. Their three-dimensional structures and folding patterns influence how each protein will behave. Analytical methods that evaluate a protein’s quality attributes need to be reproducible and robust. Proteins are evaluated through elucidating their amino acid sequences, using molecular informatics and modeling, characterizing three-dimensional structures, and understanding the degree of posttranslational modifications. The resulting knowledge will help you ensure consistency and safeguard methods.…

Bringing Biologic Products to Market Faster By Partnering with a Single Services Provider from Development Through Commercial Supply

Andrew Sandford, vice president of business development, Catalent Biologics Catalent feels strongly about “Patients First.” The core of the company’s mission is to “enhance and improve the lives of your patients.” Bringing a new drug to market is expensive, costing about US$2.6 billion per drug. It takes an average of 12 years from drug discovery to final approval, with only 1 in 5,000 products ultimately approved by the Food and Drug Administration. The expense, risk, and long timelines of drug…

Product Development Through Commercial Production: Guiding Your Biologic from Start to Finish

Eunyoung Yang, team leader and chief development officer of the business development team, Samsung BioLogics Samsung is maximizing customer satisfaction by providing customized, cost-effective, and comprehensive development and manufacturing services. It is the number-four company in the world worth, US$92.3 billion, with 672 offices in 91 countries and employing 512,000 people. Samsung provides electronics (its most well-known business), engineering and construction for heavy industries, financial services, and healthcare support including biologics manufacturing, a medical center, and electronic medical devices. Samsung…

Cultivating Better Working Relationships with Contract Manufacturing Organizations: A Panel Discussion

On 21 March 2018, a panel discussion during BPI West in San Francisco addressed ways to improve working relationships between sponsors and contract manufacturing organizations (CMOs). Our goal as organizers was to avoid retreading overfamiliar ground: Many outsourcing articles stress the importance of good communication without delving into actual strategies for improvement. So I asked the panelists to focus on the word better and what that actually means in this context. The most productive way to approach such a discussion…

Emerging Markets: Current Insights into the State of Global Biopharmaceutical Manufacturing

Opportunities for establishing strong biopharmaceutical capabilities are expanding across the globe. This e-book seeks to encapsulate the current state of emerging markets/countries, tracing key elements above and offering examples to show where (in the world) the biopharmaceutical industry is expanding and securing its footholds. Generally, to succeed in these markets, foreign companies must exercise efficient resource management and control, show creativity and receptiveness to cultural differences, develop new strategies, and manage expectations. Working with local partners can provide access to…