Sponsored Content
September 2011
Conference themes and approaches can be looked at as sort of a crazy quilt representing the state of the industry: with pieces of all different shapes and colors that come together to form a cohesive whole. They fit together in many ways, depending on the organizers (quilters?); many pieces are omitted and saved for the next quilt. But how to find the most successful combinations requires technique as well as imagination.
Here are some topics I’ve been enjoying this year so far. The annual WCBP conference and related CMC Strategy Forum early in the year are always good venues. We publish the forum’s resulting consensus papers, as you know. The particulates discussion this year was especially timely in light of new analytical techniques — and we’ll publish that paper this fall.
I returned to DC for the Phacilitate Cell and Gene Therapy conference, during which my publisher and I worked to finalize our cell therapies supplement (May). Becoming more conversant with the vocabulary and science of regenerative ...
Cosponsored by CASSS (an international separation science society) and the US Food and Drug Administration (FDA), the January 2010 CMC Strategy Forum explored antibody–drug conjugates (ADCs), which are monoclonal antibodies (MAbs) coupled to cytotoxic agents. The ADC platform of products is being used more and more for clinical evaluation in oncology. More than a dozen companies are developing several types, including products conjugated with calicheamicin, auristatins, and maytansinoids. Such products use the specificity of a MAb to deliver a cytotoxic drug to tumor cells. Depending on the chemistry of linkage, sites of attachment, and synthetic route for the small-molecule component, various chemistry, manufacturing, and control (CMC) issues arise during development and regulatory review of ADCs. Determining the appropriate assays for characterization and quality assurance (QA) is important, as is identifying potential critical quality attributes (CQAs) for the conjugate, antibody, cytotoxic agent, and ...
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In 2007, ASTM International (ASTM), formerly known as the American Society for Testing and Materials, published its “E2500-07” international industry consensus standard for conducting a risk-based design and qualification of good manufacturing practice (GMP) manufacturing systems (
1
). This guide incorporates risk- and science-based practices to focus on critical aspects affecting equipment systems throughout their design–qualification–operation lifecycle. Presentations at recent PDA and ISPE annual meetings indicate that the bioprocess industry is embracing E2500 to improve system designs and reduce costly validations. The standard describes an efficient approach to system design and qualification; however, it is not a “how-to” guide. To implement the concepts introduced, it advises companies to “develop appropriate mechanisms” and use “a systematic approach.”
Terminology is not the focus of E2500 because nomenclature does not impart functionality to a system. Neither FDA nor ICH guidances nor the US
C...
The Biologics Price Competition and Innovation (BPCI) Act of 2009 establishes an abbreviated approval pathway for biologic drugs in the United States that are demonstrated to be highly similar (biosimilar) to or interchangeable with biological products licensed by the US Food and Drug Administration (FDA). BPCI was part of the Patient Protection and Affordable Care Act (Act) that was signed into law on 23 March 2010 (
1
). As the name of the umbrella legislation implies, the legislative push for a regulatory pathway for biologic drugs is management and containment of rising healthcare costs (
2
).
Costs associated with manufacturing, product complexity, superior safety, and efficacy profiles all contribute to the high cost of biologic drugs (
2
,
3
). One report estimates a total savings of more than $71 billion over a 10-year period for generic biologics in only four therapeutic categories: interferons for multiple sclerosis, erythropoietin for anemia, growth hormone to support growth, and insulin for di...
Living systems rely on enzymes to perform many essential functions for survival. One prime example is digestion, the conversion of food into energy. Each enzyme possesses specific requirements for the types of molecules that it can use as substrates or reactants to convert to products. Here, I provide some basic information about enzymes, explain their biochemical parameters (e.g., kinetic parameters) and significance for characterization, and review related assays currently available to the bioprocess industry.
Lactose intolerance is a common enzyme deficiency throughout the world. It describes the inability or insufficient ability to digest lactose, a sugar found in milk and milk products. It is caused by a deficiency of the enzyme lactase, which is produced by cells lining the small intestine. Lactase breaks down lactose into two simpler forms of sugar — glucose and galactose — which are then absorbed into the bloodstream.
PRODUCT FOCUS
:
ENZYMES, VACCINES
PROCESS FOCUS
:
FORMULATION, PROCESSING
WHO ...
Rapidly increasing demand for cell-derived products has placed huge pressures on the biomanufacturing industry’s production capacity requirements. Media development strategies continue to be a primary focus for optimizing output from cell culture systems. Animal cells used in manufacturing protein products have complex nutrient requirements specific for each cell type, clone, and product. Individual nutrient requirements were once addressed by using serum-based media rich in growth factors and supplements, which provided an optimal culture environment for cell growth and productivity (
1
). However, the use of serum is gradually being phased out in biopharmaceutical manufacture. Seasonal and continental differences in serum composition and batch-to-batch variations lead to inconsistent cell culture performance and product quality. Moreover, because of contamination risk from blood-borne adventitious agents (mycoplasma, viruses, and prions), regulatory agencies strongly discourage the use of animal-derived...
Single-use technology is now well established for many bioprocessing unit operations, including sterile filtration and product storage, where it provides specific benefits such as elimination of cleaning and cleaning validation, reduced risk of contamination, and enclosed systems for safer handling. Recently, single-use technology has been introduced into more complex unit operations such as purification by chromatography (
1
), tangential-flow filtration (
2
), and mixing systems.
More complex processing steps, however, present a challenging task for developers of single-use products. Mixing systems fall into this category because the range of applications can be very wide, and mixing requirements often differ substantially among those. Developers of single-use mixers must take into consideration several factors: liquid–liquid and solid–liquid mixing, suspensions, immiscible liquids, fluid viscosity, shear-sensitive fluids, susceptibility to foaming, container shape and dimensions, process scale, mixing ...
Academic laboratories have embraced localized surface plasmon resonance (LSPR) as the “new wave” of label-free technology (
1
). This technique is based on the ability of colloidal metal nanoparticles or nanostructured metallic films to absorb light in a narrow wavelength range. Metal nanostructures “sense” changes occurring at their surfaces by shifting the frequency of the light they absorb or reflect. As a consequence, a basic LSPR system requires only optical fibers, a source of white light, and a detector (
1
,
2
). The simplicity of LSPR instrumentation contrasts with its exquisite sensitivity. Binding events and functional activity of nucleases (
3
) and proteases (
4
) can be monitored and quantified in real time based on observation of a single 20-nm nanoparticle — probably one of the world’s smallest biosensing supports (
5
).
Nanostructured metallic films, rather than isolated metal nanoparticles, enable commercial endeavors by their robust and reproducible nature. With recent advances in nanof...
Resin Information
Literature:
Toyopearl info in French
Applications:
Purification of proteins, peptides, and oligonucleotides
Features:
Tosoh Bioscience introduces a new website and brochure featuring the Toyopearl resin portfolio for French-speaking scientists. The website overviews materials of construction and provides links to company information. The brochure covers all aspects of biochromatography for method development and larger-scale applications: size-exclusion chromatography (SEC), ion-exchange chromatography (IEC), hydrophobic interaction chromatography (HIC), and affinity chromatography (AFC) including protein A. Small prepacked Toyoscreen columns for rapid method development are also presented.
Contact
Tosoh Bioscience
www.toyopearl.fr
Pharmaceutical Waters
Product:
Nexus systems
Applications:
Purified water and water for injection (WFI)
Features:
The Nexus range of standard, packaged, prevalidated water distribution systems offer flow rates ≤30 m
3
/h. The hygienic design and fabrica...
The BioProcess International Conference is your one-stop industry resource for driving down costs; improving quality; and achieving rapid, robust, and resilient process development and manufacturing. This is where challenges are explored, solutions are uncovered, and opportunities are developed — at the largest and most highly respected event solely dedicated to biopharmaceutical manufacturing.
New This Year
Symposia and Training
An expanded roster of preconference symposia will help you gain new skills and update your knowledge in a variety of areas:
Preconference Symposia
, Monday, 31 October 2011: “Contamination Control — Lessons Learned, Best Practices, and Case Studies”; “Incorporating Single Use in Process Development and Scale-Up”;
“Understanding Lyophilization and Designing an Optimal Lyophilization Process”; “Global Strategies and Experience in the Development of Biosimilars”; “Case Studies of Process and Analytical Transfers in Biomanufacturing”; and “Using DoE Effectively for Process Characteri...
The growth potential for biopharmaceutical companies in emerging markets is no secret. By 2015, up to 35% of the global biopharmaceutical market will be in China and other developing countries. Yet even though most companies have reset their research and development (R&D) and supply chain models to support global expansion, their regulatory submission strategies and capabilities often fall short. The number of regulatory requirements has grown exponentially as biopharmaceutical companies enter new and disparate markets, but efforts in global regulatory harmonization have stalled. To support the global growth imperative, regulatory functions must meet the local needs of a greater number of countries while supporting an expanding list of products and aggressive project timelines. Altering regulatory strategies to meet new business models will generate faster approvals and help propel growth in emerging markets.
Biopharmaceutical companies have honed their regulatory submission operating models to facilitate...
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