GMP – BioProcessing Journal

The Impact of Process Closure on Biomanufacturing Risk

“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.

Manufacturing Risk Analysis and Management

closed system contaminant control cost reduction facility design GMP process closure

Deploying Automated Buffer Production for cGMP Use: Points to Consider

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….

Manufacturing

automated buffer formulation automation buffer management chemical equilibria GMP in-line conditioning

The Establishment of a Documentation System and Quality Control Strategy for the Plantibody HB-01 Production Employed in rHBsAg Purification for Pharmaceutical Use

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…

Biologics Production Regulatory

documentation GMP immunopurification plantibody quality control transgenic plants

Dendritic Cell Vaccine Production Facility: From Design to Operation

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…

Manufacturing Regulatory

closed cell culture dendritic cell vaccine facility design GMP process development vaccines

Vero Cells in Vaccine Production

The Vero cell line is one of the most widely used continuous cell lines in the world, cited in over 10,000 publications. Though originally developed as a host for viral replication, uses for this highly adaptable cell line have expanded far beyond the research laboratory to include diagnostic practices in hospitals, epidemiological surveys, in vitro fertilization clinics, bacterial toxin assays, and vaccine production. ATCC has played a pivotal role in this expansion by distributing the Vero cell line, ATCC® CCL-81™, to the worldwide scientific research community. Recently, ATCC developed a fully-characterized master cell bank of Vero cells prepared under current good manufacturing practice (cGMP) conditions (ATCC® CCL-81.4™). This report traces the history of the Vero cell line from its origins in the laboratory of Dr. Yosihiro Yasumura to its use as a continuous cell substrate for vaccine manufacturing…

Biologics Production Cell & Tissue Banking

continuous cell line continuous cell substrate GMP vaccines Vero cells viral vaccines

Fitting a Square Peg into a Round Hole: Methods Development, Qualification and Validation for Complex Biological Products

Manufacturers of biological products have come to accept that it makes sense, from both a business as well as a regulatory perspective, to address GMP compliance issues with bioprocessing methods as early as possible in product development. Logically, this same reasoning would also apply to the associated analytical methods used to characterize the product; however, companies still frequently leave methods optimization and validation until later in the developmental timeline which can expose them to unexpected regulatory challenges. In addition, as therapeutics increase in complexity (e.g., cell therapies, transgenics), it raises the likelihood that product characterization will be assessed by novel and increasingly intricate assays—making it difficult to follow a “one size fits all” approach to method selection, development and validation…

Manufacturing Regulatory

analysis FDA GMP method qualification validation

GMP Production of an Encapsulated Cell Therapy Product: Issues and Considerations

One of the major concerns facing relatively young biotechnology companies once a lead product has been identified is the issue of manufacturing. Usually this involves the upscaling of a lab-scale process while at the same time, complying with good manufacturing practice (GMP) to ensure a reproducibly-produced and consistent product. It also involves the establishment of specific and robust assays in process controls and release criteria. This issue has become more acute in the EU since 2004 due to the EU Clinical Trials Directive requiring GMP-certified production of investigational medical products even for phase I trials. Startup biotech companies are often limited in their finances and resources, as well as being bound by tight milestones. Quite often the expertise in upscaling and GMP-compliant production as well as the facilities and equipment required are not available in-house…

Cell & Gene Therapy Manufacturing

automation contract manufacturing GMP outsourcing quality control scale-up technology transfer

Design of a Biotech Clinical Trial Manufacturing Facility

Key questions for any company planning to build a new facility include processes to be followed for effective design, commissioning, and qualification. Pilot plants need to be flexible, but as flexibility increases, so does complexity and cost. The scope of the new clinical trial pilot plant for bioprocess operations at Eli Lilly and Company (K360) was based on specific technology platforms and extensive benchmarking. Global regulatory issues had to be considered in the design as well because the material it produces will be used worldwide. The K360 plant has the capability to produce mammalian, bacterial, and yeast-based protein and peptide products following typical processes for growth in bioreactors. The protein or peptide of interest is recovered following fermentation and then purified in the facility. The plant’s output is bulk active pharmaceutical ingredient (API)…

Manufacturing

automation bulk active pharmaceutical ingredient manufacturing clinical trials facility design GMP

Considerations for Characterization and Comparability of Recombinant DNA-Transduced Cellular Products

Recombinant DNA-transduced cellular products encounter the product development and regulatory issues of both gene therapy and cellular therapy products. The characterization of recombinant DNA-transduced cellular products remains highly challenging for both sponsors and regulatory agencies. The regulatory concerns and product testing for such cellular products are similar to those for all biologicals. These concerns include the demonstration of product safety, identity, purity, and potency; the control of the manufacturing process to ensure the consistency of product manufacturing under a proper quality control program; and the demonstration of reproducibility and consistency of product lots by means of defined product lot release testing criteria…

Cell & Gene Therapy Regulatory

characterization comparability FDA GMP quality control recombinant DNA-transduced cellular products testing

Managing Technology Transfer for Cost-Effective Development and Manufacturing of Biopharmaceuticals

In today’s aggressive biopharmaceutical market, many drug discovery organizations, including both big pharmaceutical companies and small technology start-up companies, are outsourcing the development and manufacturing of their biopharmaceuticals to specialized contract manufacturing organizations (CMOs). Outsourced biopharmaceuticals range from those in early phase production to products that are well advanced down the development pipeline. As a result, there has been an expansion of CMOs that specialize in all aspects of biopharmaceutical manufacture, from process invention and development, through small-scale GMP production, to process validation and large-scale manufacture. The CMOs provide R&D services, quality function, and state-of-the-art good manufacturing practice (GMP) facilities needed for the production of biopharmaceutics. Using CMOs for biopharmaceutical process development and manufacture provides major cost savings by dispensing with the need to invest in experienced personnel and expensive manufacturing facilities…

Manufacturing

contract manufacturing GMP outsourcing process development technology transfer

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