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 UPSTREAM PROCESSING

Biochemicals and Raw Materials

Consistency in Peptone Manufacturing:
Modern Methods Make a Difference
(Technology Review)

What factors impact peptone variability? Variability can be linked to at least two critical elements: the biological raw materials and the production site. Raw materials can vary by species of animal or plant sourced, type of components... READ MORE   

How Clean Is Your BSA? (White Paper)

Bovine serum albumin (BSA) is a critical component of many biotechnology and biochemistry systems. BSA is used in a variety of applications, including diagnostics, veterinary medical products, vaccine manufacturing, mammalian cell ... READ MORE   

Cell Culture Media

Amplify Your Titer: Kerry’s AmpliCHO CD Medium (Technology Review)

For more than 75 years, Kerry has earned its reputation for reliability and excellence in serving the biotechnology, pharmaceutical, and nutrition markets. We deliver innovative solutions to assist customers increase cell proliferation... READ MORE   

Contract Services

Extractables and Leachables Studies: Designed and Performed to
Meet All Intended Needs
(Technology Review)

There are no definitive requirements on how to perform extractables and leachables (E&L) studies. However, the US Pharmacopeial Convention recently released two chapters to provide guidance on performing E&L studies. USP chapters <1663> and... READ MORE

Expression Platforms

Looking into the Future: An Interview with Steve Bagshaw,
CEO of Fujifilm Diosynth
(Capabilities Review)

Steve Bagshaw, chief executive officer at FUJIFILM Diosynth Biotechnologies, offers some insight into the ever changing CDMO landscape and the future of medicine. Mr. Bagshaw is an industry thought leader and an advocate of the Biotechnology Industry... READ MORE

Production of Biotherapeutics Using GlycoExpress® Expression Platform Technology (Technology Review)

GlycoExpress® (GEX®) technology is a well-established human expression platform for the screening and production of biotherapeutics. By contrast with other human cell lines (e.g., HEK293 and Per.C6) GlycoExpress® expression platform... READ MORE

Gram-Scale Transient Antibody Production and Stable Cell Line Generation
Using Flow Electroporation™ Technology
(White Paper)

MaxCyte’s delivery platform is a universal, high-performance transfection technology that significantly reduces risk and shortens biotherapeutic development timelines by enabling researchers to perform early-stage development in the biomanufacturing... READ MORE

Unlock Pichia: High-Level Methanol-Free Protein Production in Pichia pastoris (White Paper)

Pichia pastoris (Komagataella phaffii) is recognized as a highly competitive expression system for fast and economic production of recombinant proteins. Pichia offers many advantages. It is an established (FDA and EMA approved) safe (generally recognized as safe... READ MORE

Single-Use Technologies

Push-Button Simplicity: Automatic Fermentation with the BioFlo® 120
Auto Culture Mode
(Technology Review)

Learning to use a bioprocess controller is a complex endeavor. Even if someone has previous bioprocess experience, moving to a new software platform can entail much learning and reduce process efficiency... READ MORE   

Automation and Modularity Allow MAb Biotech to Cut Scale (Technology Review)

Original developers of biosolutions and products, especially those facing the debut of biosimilars in core markets, have an urgent imperative to reduce manufacturing costs through increased productivity and yields.… READ MORE

Single-Use Diaphragm Valve (Technology Review)

There is now a larger selection of the world’s first controllable single-use diaphragm valve: GEMÜ SUMONDO. GEMÜ has established the first controllable single-use diaphragm valve on the market: the GEMÜ SUMONDO. In addition to a pneumatically… READ MORE

Novel Single-Use Systems Allow for Faster Powder Transfer and Higher Recovery Rates (Technology Review)

Single-use powder containment is vital in today’s safety-focused manufacturing environment. Preventing product from cross-contamination and reducing airborne particulates is a major concern. Understanding how modern bag designs...  READ MORE

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 DOWNSTREAM PROCESSING

Chromatography

A Novel Cellufine Mixed-Mode Resin: Cellufine™ MAX IB for Polishing of Monoclonal Antibodies (Technology Review)

Cellulose is well-known as a natural raw material that has mechanical strength, lower nonspecific adsorption, and good biocompatibility. Additionally, cellulose particles have unique pore-size characteristics appropriate for the chromatography... READ MORE   

Continuous Chromatography: A Multifunctional, Twin-Column Continuous Chromatography
in a Simple, Robust Design
(Technology Review)

LEWA EcoPrime® Twin LPLC is an easy-to-use, GMP-ready, multicolumn chromatography system offering analytical performance for continuous chromatography from process development to large-scale biopharmaceutical production... READ MORE   

BioSC® in a Fully Integrated Continuous MAb Manufacturing Process (Technology Review)

With the demand of higher production and reducing cost in biological manufacturing, continuous bioprocessing is replacing the traditional batch-mode manufacturing. Many biopharmaceutical companies are seeing the benefits... READ MORE

Cleaning and Sanitization

Bioburden: Current Innovations and Practices to Address Microbial Contamination in Downstream Bioprocessing (White Paper)

Bioburden control is an area of serious concern for both manufacturers of biologicals and suppliers to the industry. This white paper considers some of the risks related to downstream processing and presents recent developments... READ MORE   

Separation and Purification

The Forgotten Immunoglobulin” LigaTrap™ Technologies and Advancements in IgM Purification (White Paper)

It’s been over 30 years since the identification and commercialization of protein A. Since its inception, protein A has served as the pinnacle purification platform for the immunoglobulin G (IgG) subclass of antibodies, both monoclonal and polyclonal forms... READ MORE   

Endotoxin Removal in a New Scalable Dimension (Technology Review)

Endotoxins are degradation products from dying gram-negative bacteria and complex aggregates of acidic lipopolysaccharides (LPS). Each is composed of lipophilic lipids and hydrophilic polysaccharides. In humans, endotoxins can cause immune... READ MORE   

KanCapA™ 3G: An Innovative Protein A Resin for MAb Manufacturing (Technology Review)

Recent improvements in monoclonal antibody (MAb) upstream process technologies have led to increased product titers (from 5 to 10 g/L) and a corresponding change in impurity levels. To yield highly pure MAb drugs from such high-titer feedstocks... READ MORE  

Prometic Bioseparations (Capabilities Review)

Since 1987, Prometic Bioseparations Ltd. (PBL) has been pioneering the design, development, and manufacture of affinity purification technology for laboratory-scale and industrial-scale bioprocessing. With 30 years’ experience in the... READ MORE   

Capturing a scFv from E. coli Using Protein L Affinity Chromatography (Technology Review)

Single-chain variable fragments (scFv) are antibodyderived molecules with several advantages over full-length IgGs, including rapid target access and good tissue penetration. Straightforward and efficient capturing solutions similar to protein A... READ MORE   

Single-Use Technologies

Genderless Sterile Connectors: How Single-Use Connectors Can Increase Efficiency, Saving You Time and Money (Technology Review)

Standardizing equipment in biopharmaceutical production streamlines operations, saving end users time and money. An area ripe for standardization is the use of genderless connections, those in which the connector halves are identical in design... READ MORE  

The Experts in Noninvasive Liquid Flow Measurement Via the Ultrasound Transit Time Method (Technology Review)

Germany-based em-tec GmbH has been developing and manufacturing products and components for the medical and bioprocessing industry for decades. With many years of experience, em-tec has become known as a strong partner for consulting... READ MORE  

Reducing Complexity of Custom Single-Use Assemblies (Technology Review)

Since the introduction of single-use technologies (SUTs) more than 20 years ago, their benefits have been well recognized, and their adoption has been swift. The ability to customize a solution for every operation, every scale, and every... READ MORE 

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 MANUFACTURING

Antibody/Non-Antibody

MabPlex: Custom, Flexible, and Reliable Contract Development and Manufacturing (Capabilities Review)

MabPlex provides world-class solutions to biopharmaceutical clients around the world. Our company is based on the quality by design (QbD) principle, from site construction to manufacturing and delivery of our clients’ biologic drugs... READ MORE   

Contract Services

Who We Are (Capabilities Review)

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people... READ MORE   

Let’s Make Your Success — Biologics Manufacturing: Relentlessly Dedicated
to Your Drug Program
(Capabilities Review)

Althea is a fully integrated contract development and manufacturing organization providing clinical and commercial drug product services. Althea offers cGMP drug product filling in both vials and syringes and production of microbial-derived recombinant... READ MORE   

Continued Expansion of Our State-of-the-Art Facilities and Services: Meeting All Your Manufacturing Needs from Development to Commercialization (Capabilities Review)

Avid Bioservices is a contract development and manufacturing organization (CDMO) specializing in mammalian cell culture process development and cGMP production of clinical and commercial-scale monoclonal antibodies, recombinant proteins... READ MORE   

Accelerated Development Through Strategic Analytical Partnerships (Capabilities Review)

The analytical field for biologics has evolved greatly over the past 30 years, and the underlying growth has shifted from biopharmaceutical companies to contract research organizations (CROs). The global biopharmaceutical market is growing... READ MORE   

Expanded Biomanufacturing Center of Excellence: Increasing Flexibility and Manufacturing Scale for Customized Solutions (Capabilities Review)

Our state-of-the-art biologics manufacturing facility (which uses single-use systems) is expanding to add 22,000 ft2 of space and with that, the flexibility and scale to support your growth. The expansion adds a new 2 × 2,000-L single-use bioreactor... READ MORE   

Quality By Design: Transforming 21st Century Pharmaceutical Manufacturing
(Technology Review)

The quality of pharmaceutical products is the top priority for both biopharmaceutical companies and regulators. To ensure consistently high product quality and improve the efficiency of manufacturing and regulation, the US FDA introduced... READ MORE   

Rentschler: A World-Class Biopharmaceutical CDMO (Capabilities Review)

Rentschler Biotechnologie GmbH, located in Laupheim, Germany, is a leading biopharmaceutical contract development and manufacturing organization (CDMO) for bioprocess development and manufacturing of biopharmaceuticals... READ MORE   

Biopharmaceutical Development and GMP Manufacturing: Preclinical to Commercial Supply (Capabilities Review)

Richter-Helm is a Hamburg, Germany–based contract development and manufacturing company with a proven 25-year track record, specialized in products derived from bacteria and yeasts. Count on us to flexibly provide a comprehensive range... READ MORE   

The Microbial CMO: Process Development and Manufacturing of Biologics (Capabilities Review)

Wacker Biotech is “The Microbial CMO” — the partner of choice for contract manufacturing of therapeutic proteins using microbial hosts. Our service portfolio covers molecular biology, process and analytical development, and the GMP production of biologics... READ MORE   

Single-Use Technologies

The Many Strengths of One Film: Fortem™ Single-Use Platform Film Built for Bioprocess (Technology Review)

Single-use technology has been transforming the modern biomanufacturing workflow. You can now find single-use bags at every stage of bioprocessing: bioreactor and mixing systems, harvest and collection, purification, liquid and powder storage... READ MORE   

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 Analytical Methods and Instrumentation

Downstream Development

Is Your HCP Assay Fit for Purpose? (Technology Review)

Removal of host cell protein (HCP) impurities in drug substances is critical in the manufacture of highquality drug products and for patient safety. A key requirement is a thorough analysis of HCP contaminants, which may vary considerably... READ MORE   

Sensors

Dissolved Oxygen Quantification in a DO-Sensitive Product: Study of DO Values at Laboratory and Industrial Scales (Technology Review)

Sulfur is an essential component of all living cells. In plants and animals, the amino acids cysteine and methionine contain most of the sulfur, and the element is present in all polypeptides, proteins, and enzymes that contain these amino acids... READ MORE   

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 Posters

Nonaffinity-Based IgM Purification Platform

The biological properties of IgM antibodies make them very effective vehicles for in vitro diagnostics and therapeutics. However, purification of IgM antibodies is far more complex than that for IgG antibodies. Furthermore, affinity chromatography is not... READ MORE   

Effective Viral Clearance in mAb Purification Using TOYOPEARL® Resins

Impurities such as viruses are typically present during the manufacturing of biological drugs. The viruses may be present in the unprocessed material from the upstream collected harvest, such as released from cell culture media (endogenous) or... READ MORE   

Identification of Process Parameters Which Underpin Robust Platform Production Processes

Critical objectives for the biopharmaceutical industry are the creation of robust, reproducible processes which result in consistent critical product quality attributes and yields. To meet these requirements within a short time period it is... READ MORE   

Collaborating to Address the Bioburden Challenge

Bacteria and their byproducts can negatively affect the safety and potency of a biopharmaceutical drug. At a minimum, bioburden contaminations lead to reduced productivity as a result of lost batches and/or deviation investigations... READ MORE   

Purification of Antibody Fragments with Amsphere™ A3 Protein A Resin

The binding mechanism between the engineered C domain of the Amsphere™ A3 protein A (PrA) ligand and a VHH single domain antibody (sdAb) was revealed. Binding sites in the PrA ligand in helices 2 and 3 and in framework regions 1 and 3 of the VHH... READ MORE   

Modular, Single-Use Facilities Increase Biomanufacturing Flexibility

The pipelines of biopharmaceutical companies are becoming increasingly diverse while improvements in cell lines are leading to more productive bioprocesses. These factors are driving new capacity demands for bio-pharmaceutical companies and their... READ MORE   

Resin Selection to Optimize the Flexural Strength of Bioprocess Film

Abstract Single-use bioprocess technology offers several advantages for manufacturing biopharmaceuticals, such as increased transportability of fluids throughout the bioprocess workflow and a greater diversity of systems to support specific unit... READ MORE   

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