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Successfully Outsourcing Formulation DevelopmentConsiderations for Emerging Biopharmaceutical CompaniesSuccessfully taking a new chemical entity from proof-of-concept to commercialization requires the biopharmaceutical company to carefully evaluate a contract services provider's formulation department and ability to become a fully integrated supplier.
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Sieve Use in the Pharmaceutical IndustryAsieve or screener is an essential part of every pharmaceutical production process, particularly as product quality and integrity are so important. The use of a sieve gets rid of oversized contamination to ensure that ingredients and finished products are quality assured during production and before use or despatch.
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Documentary EvidenceA look at the role of document management in the product life-cycle and how this can lead to the effective use of CTDs and e-CTDs when compiling compulsory regulatory submissions...
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The Next Generation of Aseptic Processing EquipmentThe industry has acknowledged only recently the significance of the contamination risk posed by humans. The authors assert that this realization, together with technological advances, will lead to the elimination of human intervention and, hence, improved sterility.
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Steps Towards Demystifying Risk-Based Decision MakingIt is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
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Creating a compelling business case for your LIMS implementationThis article examines the development of a business case to secure coveted funding for a LIMS implementation. Information on hard cost savings and soft benefits of implementing a LIMS system, and managing the compilation of the cost justification are covered.
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Scaling down biopharmaceutical operations Part 1: FermentationCreation and qualification of scale-down models are essential for performing several critical activities that support process validation and commercial manufacturing. As shown in Figure 1, these activities include process characterization and production support studies that are performed to evaluate column and membrane lifetimes, demonstrate clearance of host-cell impurities and viruses and troubleshoot manufacturing issues. While the underlying fundamentals are relatively the same as those when scaling up, some unique considerations should be taken when scaling unit operations down.4
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Why It Pays To Be CleanProcess industries are faced with increasing demands for product safety, improved quality, efficiency and profitability. The chemical, pharma and cosmetic industries are no exception.
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Viral filtration of plasma-derived human IgGHuman plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of therapeutic products have been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring and Octagam from Octapharma.
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The shape of things to comeParticle shape is an important parameter to monitor in the pharmaceutical sector, but has, historically, been too complicated to measure and be utilized on a routine basis. A newly developed digital technique could change this.
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Computer system validation ? increasing supplier valueAll sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.
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Reducing Time to Market with A Science-Based Product Management StrategyTo progress compounds from candidacy to IND rapidly, manufacturers can adopt a strategy that involves front-loading as many studies as possible to reduce the number of potential problems, finding the best solid form for manufacture through a polymorph study or screen, developing a manufacturing process and formulation that preserves this form, and adopting process analytical technology and quality-by-design principles.
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Discrete Element Simulation for Fundamental Process UnderstandingThe pharmaceutical industry handles large volumes of granular materials such as powder blends for tablet production and filled capsules everyday (1, 2). Slight changes in ingredient properties or process operation conditions can have a major effect on a finished product's quality. Given the market and regulatory uncertainties that are commonly associated with drug product development, pharmaceutical companies typically have several drugs in various developmental stages at the same time. Because of this volume, the industry must have computer-based rapid-prototyping tools that can efficiently capture and resolve the technical aspects of drug product development so that companies can confidently make decisions about drug portfolio management and planning (3, 4).
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Pharmaceutical clean rooms: specialty hygiene coatingsClean rooms are areas in which it is essential that microorganisms are not allowed to proliferate because they could contaminate pharmaceuticals and directly affect human health.
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Lean Manufacturing practice in a cGMP environmentDeveloped in the 1950s as a means to survive and compete against the giants of the automotive sector, lean manufacturing helped Toyota evolve from a small-volume producer (with little capital) to become a high-volume manufacturer in a process-rich environment. Toyota achieved this by using developments such as total production maintenance (TPM), just-in-time (JIT), Kanban, value stream mapping and Kaizen events.1 A summary of some of the lean terminology is shown in Table 1.
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The Clarification of Bioreactor Cell Cultures for BiopharmaceuticalsClarification processes are critical steps in production of biological products because they directly affect yield, product consistency, and reproducibility.
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Discrete Element Simulation for Fundamental Process UnderstandingThe pharmaceutical industry handles large volumes of granular materials such as powder blends for tablet production and filled capsules everyday (1, 2). Slight changes in ingredient properties or process operation conditions can have a major effect on a finished product's quality. Given the market and regulatory uncertainties that are commonly associated with drug product development, pharmaceutical companies typically have several drugs in various developmental stages at the same time. Because of this volume, the industry must have computer-based rapid-prototyping tools that can efficiently capture and resolve the technical aspects of drug product development so that companies can confidently make decisions about drug portfolio management and planning (3, 4).
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Scaling down biopharmaceutical operations Part 1: FermentationCreation and qualification of scale-down models are essential for performing several critical activities that support process validation and commercial manufacturing. As shown in Figure 1, these activities include process characterization and production support studies that are performed to evaluate column and membrane lifetimes, demonstrate clearance of host-cell impurities and viruses and troubleshoot manufacturing issues. While the underlying fundamentals are relatively the same as those when scaling up, some unique considerations should be taken when scaling unit operations down.4
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Rapid Results for life Science ApplicationsEssentially, RAD is a set of tools…that allows for rapid prototyping and reiterative testing that enable faster development and implementation of new applications.
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High-Resolution Ultrasonic Spectroscopy: Analysis of MicroemulsionsThis article introduces the application of high-resolution ultrasonic spectroscopy (HR-US) for the analysis of emulsions and suspensions. The authors outline the principles of the technique and illustrate its application for analysis of the crystallization of lysozyme and the formation of a microemulsion.
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USP Initiatives for the Safe Use of Medical GasesUSP monographs, if they are consistently observed and applied, can help reduce medical gas errors.
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Virtual screening using chemical feature-based pharmacophores and virtual molecule librariesThe discovery of suitable lead structures for new drugs from an inexhaustibly large reservoir of theoretically possible compounds is one of the biggest challenges for the pharmaceutical industry. In the last few years, combinatorial chemistry methods have been developed to synthesize a huge amount of diverse new chemical entities (NCEs), which may subsequently be tested for biological activity in vitro.
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When Simple Isn't Good EnoughAlthough there is no global regulation or industry standard on labelling requirements, some organizations are beginning to lay down their own standards.
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Challenges and Strategies for the Downstream Purification and Formulation of Fab Antibody FragmentsAntibody fragments pose unique challenges in terms of recovery, purification, and formulation.
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Making tissue culture commercially viableThere are over 250 operations in the EU in various stages of development involving tissue engineering, regeneration and subsequent attempts at commercialization.
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Integrating PAT with MESWith all the challenges that the manufacturing industry has had to deal with over the last ten years - growing compliance demands, increased competition and price pressures - it is perhaps not surprising that pharmaceutical firms are increasingly trying to streamline their manufacturing processes to maintain profit margins, speed up the time-to-market, as well as comply with market regulations that are becoming increasingly stringent.
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IMS Limit Test Improves Cleaning Verification and Method DevelopmentA limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.
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Scaling down biopharmaceutical operations Part 1: FermentationCreation and qualification of scale-down models are essential for performing several critical activities that support process validation and commercial manufacturing. As shown in Figure 1, these activities include process characterization and production support studies that are performed to evaluate column and membrane lifetimes, demonstrate clearance of host-cell impurities and viruses and troubleshoot manufacturing issues. While the underlying fundamentals are relatively the same as those when scaling up, some unique considerations should be taken when scaling unit operations down.4
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Enforcing GMP compliance for APIs in EU medicinesThe Active Pharmaceutical Ingredients Committee (APIC) - a sector group of Conseil European des Federations de l'Industrie Chimique (CEFIC) - first voiced the need for EU GMP API legislation in 1993 to help ensure the safety of medicines. In 2000, the International Conference on Harmonisation (ICH) finalized the harmonized API GMP Guideline Q7, which became legal in the US and Japan in 2001. The EU adopted a directive in March 2004 that includes the requirement for APIs in medicines for the EU market to comply with ICH/Q7A. Member States are transposing the directive into their national law: about half of them have completed this process, seven more are well on their way to completion, while seven others are still in earlier stages of adoption.
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Direct Compression: Microcrystalline Cellulose Grade 12 versus Classic Grade 102Although the most commonly used microcrystalline cellulose grade in direct-compression applications is the fine grade 102, the use of coarse grade 12 may offer better weight and content uniformity results.
