Contract testing organizations (CTOs) offer considerable value by providing testing services and expertise that may not be available within organizations that are developing and producing biopharmaceuticals, from virtual companies to fully integrated international organizations. CTOs are constantly challenged by the breadth of services that are requested as well as the levels of regulatory compliance that are expected and the degree of oversight that various companies intend to impose. And knowing this variability of needs and expectations often results in a CTO trying to become “all things to all people” regarding assay tech transfer, validation, and qualification. For example, with the same type of sample from the same stage of product development, one company may expect its contracted testing to comply with 21 CFR Part 210 and 211 (good manufacturing practice [GMP]) while another may expect its testing to comply with 21 CFR Part 58 (good laboratory practice [GLP]) with different assay validation expectations for each approach…
Tag: <span>GMP</span>
Biosimilars, and related biopharmaceutical biobetters and biogenerics, are still relatively new, but are already starting to impact worldwide biopharmaceutical markets. Most discussions of biosimilars center on developed regions where markets are mature and manufacturing capabilities allow for the cost-efficient manufacture of these complex molecules. This article covers the development of these products outside the United States (US), European Union (EU), and other developed, generally rather affluent and high-technology economy-based countries. To start, we first offer some definitions…
Biopharmaceutical manufacturing will continue to be increasingly challenging as medical knowledge and understanding rapidly advance. Many new therapies and products will utilize cellular, viral, genetic, and epigenetic approaches along with a repertoire of increasingly complex proteins targeting a rapidly increasing inventory of newly discovered biomarkers. Manufacturing these products efficiently, consistently, and reliably will require sophisticated manufacturing approaches, methods, and controls. In addition, growing patient, societal, and even regulatory pressures demand that new therapeutics be developed and manufactured quickly, reliably, and efficiently.
Biopharmaceutical manufacturing will continue to be increasingly challenging as medical knowledge and understanding rapidly advance. Many new therapies and products will utilize cellular, viral, genetic, and epigenetic approaches along with a repertoire of increasingly complex proteins targeting a rapidly increasing inventory of newly discovered biomarkers. Manufacturing these products efficiently, consistently, and reliably will require sophisticated manufacturing approaches, methods, and controls. In addition, growing patient, societal, and even regulatory pressures demand that new therapeutics be developed and manufactured quickly, reliably, and efficiently. Historically, manufacturing has been viewed and managed in terms of minimizing patient safety risks.
“Closed system.” The term itself appears deceptively simple. However, the definition of a closed system, its implementation, and its impact on biomanufacturing has been anything but straightforward.
The journey toward implementing closed systems spans over 20 years. The concept of closed systems was introduced in January 2000 with the draft issue of ICH Q7. Since then, other industry guidance documents emerged, defining and supporting process/system closure as a primary means of risk mitigation to meet the baseline requirement of protecting the product, as defined in cGMP.
Presently, global regulatory agencies recognize three distinct definitions of a closed system. These definitions, found in EU Annex 1, EU Annex 2, and the PIC Annex 2A, all focus on product protection where the product is not exposed to the immediate room environment during manufacturing. This is where the journey begins.
Biopharmaceutical manufacturing often takes place in tank farms – facilities in which large-volume vessels are used to support cell culture processes with equally sized, or even larger buffer preparation and storage tanks to support downstream processing. While the large cell culture vessels used to produce products are justifiable, current downstream buffer management approaches relying on high-capacity tanks lead to constraints on facility construction, operations, and plant flexibility….
Regulatory agencies routinely announce changes in the GMP (Good Manufacturing Practices) norms and quality standards designed to guarantee that every product retains characteristics required for its pharmaceutical use.The alignment with emerging regulatory requirements is mandatory, therefore, to assure production process consistency, as well as the safety and efficacy of the finished product…
In order to move product development forward, the majority of biotech companies and academic institutions involved in cell-based therapies need new facilities in order to scale up production capabilities and comply with evolving regulatory requirements. Some institutions choose to use a contract manufacturing organization (CMO) to benefit from established expertise while others support their clinical development programs with their own dedicated production facility. The main challenges in establishing a dedicated pilot-scale production facility are described hereafter…