Bio-Outsourcing

Microsampling in Early Phase Drug Development

Altasciences | 10-May-2022 | Technical / White Paper

Microsampling significantly lessens the volume of blood and plasma/serum that is collected and analyzed to determine circulating concentrations of therapeutic...

Seasonal Vaccine Manufacturing

Baxter BioPharma Solutions | 16-Feb-2022 | Technical / White Paper

The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting...

Consideration and Options for Prefilled Syringes

Baxter BioPharma Solutions | 16-Feb-2022 | Technical / White Paper

Convenience, product differentiation, and less waste are great reasons for developing a product in a prefilled syringe. Baxter’s whitepaper describes the...

Partner with Experts in Precision Medicine

CellCarta | 17-Jan-2022 | Product Brochure

At CellCarta, we’re dedicated to working with our partners to further the limitless potential of precision medicine. Our broad technology offering is designed...

High quality excipients and formulation support

Roquette Pharma Solutions | 09-Nov-2021 | Product Brochure

As the world grapples with the effects of ongoing health crises, the market is expanding quickly as developers shift their focus to proactive therapeutics....

Tools for Confident Environmental Monitoring in the Pharmaceutical Industry

Recorded the 06-Oct-2021 | Webinar

Careful product design and controlled manufacturing of culture media can enable high levels of confidence in environmental monitoring results. New Thermo...

Rapid Biosafety Testing Enables the Future of Manufacturing

Viral Safety for mAb: Prevent, Detect, Remove | 23-Nov-2020 | Technical / White Paper

This white paper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing...

Blazar™ Platform: Rodent Virus Panel

Viral Safety for mAb: Prevent, Detect, Remove | 16-Nov-2020 | Technical / White Paper

We have a long history of developing innovative molecular technologies for cell line characterization and lot release testing for the biopharmaceutical...

Cell and Gene Therapy Definitions for Raw Materials, Starting Materials, Drug Substance and Drug Product

MilliporeSigma - Gene Therapy | 16-Nov-2020 | Application Note

The complexity of processes to manufacture cell and gene therapy medicinal products can cause confusion around definitions of raw materials, starting materials,...

Monitoring SARS-CoV-2 interaction with ACE2

Take the Right Path Upstream with MilliporeSigma | 02-Nov-2020 | Technical / White Paper

In this technical note, we investigate the interactions between the following: The spike glycoprotein binding with ACE2, Spike glycoprotein and anti-spike...

CDMO Process Development Template

MilliporeSigma - Gene Therapy | 26-Oct-2020 | Infographic

Process development is a crucial step in viral vector manufacturing and a successful CDMO partnership can help navigate the challenges associated with...

Infographic - road map to commercialization

MilliporeSigma - Gene Therapy | 19-Oct-2020 | Infographic

With the current increase in development and investment, gene therapy companies will increasingly be looking to streamline the manufacture and commercialization...

Process Development for Viral Vector Manufacturing

MilliporeSigma - Gene Therapy | 15-Oct-2020 | Infographic

Process development is a crucial step in viral vector manufacturing and a successful CDMO partnership can help navigate the challenges associated with...

Your Gene Therapy Partner From Discovery To Commercialization

MilliporeSigma - Gene Therapy | 12-Oct-2020 | Product Presentation

The MilliporeSigma organization is dedicated to supporting your cell and gene therapy from early phase through product release. Not only does our BioReliance®...

Robust, load-independent viral clearance in monoclonal antibody purification with Natrix® Q chromatography membrane

Viral Safety for mAb: Prevent, Detect, Remove | 12-Oct-2020 | Application Note

Anion exchange chromatography is an important step for viral clearance of monoclonal antibodies. Natrix® Q chromatography membrane improves cost-efficiency....

Updated US FDA Guidance For The Gene Therapy Industry: Key Changes And Areas Of Increased Focus.

MilliporeSigma - Gene Therapy | 01-Oct-2020 | Application Note

In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene therapy...

Accelerating Cell Line and Process Development

Take the Right Path Upstream with MilliporeSigma | 01-Oct-2020 | Technical / White Paper

Development of a high-producing cell line supported by a robust upstream process are critical early steps in the production of monoclonal antibodies (mAbs)....

Optimization, Validation and Implementation of Retroviral Retentive Filters for Production of Adeno-Associated Virus (AAV)

MilliporeSigma - Gene Therapy | 15-Sep-2020 | Application Note

Viral contamination is a risk for all biotechnology products. Recent studies have shown that viral retentive filtration is one of the most robust steps...

Strategies for Upstream Intensification

Take the Right Path Upstream with MilliporeSigma | 01-Sep-2020 | Technical / White Paper

The Facility of the Future represents a transformation in how biologics are developed and manufactured.

Reducing The Risk During Cell And Gene Therapy Development And Manufacturing

MilliporeSigma - Gene Therapy | 05-Aug-2020 | Technical / White Paper

While new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing...

Upstream Intensification – Enabling Perfusion Processes with Cell Retention Technologies

Take the Right Path Upstream with MilliporeSigma | 05-Aug-2020 | Technical / White Paper

Upstream processes can be intensified using high cell density cryopreservation, perfused seed train or production processes with steady-state perfusion,...

A Cost Analysis and Evaluation of Perfused Seed Train Scenarios Through Process Modeling

Take the Right Path Upstream with MilliporeSigma | 20-Jul-2020 | Technical / White Paper

This white paper describes process modeling and compares the process economics of a conventional upstream process versus three perfused seed train alternatives...

Seed Train Intensification Using High Cell Density Cryopreservation and Specially-designed Expansion Medium

Take the Right Path Upstream with MilliporeSigma | 20-Jul-2020 | Technical / White Paper

Strategies such as process intensification have the potential to create shorter lead times, reduce plant footprint, increase flexibility, and reduce COGs.

Learn more about KLEPTOSE® BioPharma for your protein stability challenges

Roquette Pharma Solutions | 14-Jun-2019 | Case Study

Therapeutic proteins are inherently unstable and sensitive to temperature change, shearing, shaking, solvents, ionic strength, purity, protein concentration,...

Marken Delivers Compassionate Use Dose of Emergency Medication to Critical Pediatric Patient

Marken | 02-Jul-2018 | Case Study

A desperate mother in Germany urged her team of doctors to reach out to a Marken client on behalf of her two year old girl. The child was battling leukemia...

High-Density Vero Cell Perfusion Culture

Eppendorf for Bioprocess – Solutions that grow with you | 01-May-2018 | Application Note

Viral diseases like rabies, rotavirus and influenza are causing many deaths worldwide, resulting in a strong demand for more productive manufacturing techniques...

Survey Report: State of the global biomanufacturing and bioprocessing industry 2017

William Reed | 19-Oct-2017 | Research Study

In September 2017, BioPharma-Reporter.com conducted its second annual ‘state of the industry’ survey on its user base of biopharmaceutical industry professionals....

The Next Stage – Eppendorfs new Mastercycler X50

Eppendorf for Bioprocess – Solutions that grow with you | 05-Sep-2017 | Application Note

The Mastercycler X50 is Eppendorf's new PCR cycler with lots of new benefits. Not only can you heat with 10°C/s, you can also optimize two different...

Method for Optimizing mAb Polishing Using CMM HyperCel™ Mixed-Mode Cation Exchanger

Pall Biotech | 12-Jun-2017 | Application Note

mAbs are produced for a number of therapeutic applications. However, mAbs are not a homogeneous family of products. Each mAb is unique, based on its isoelectric...

Novel Analytical Techniques For Monoclonal Antibodies

With the rising interest in biopharmaceuticals, drug developers need to quickly understand and evaluate the binding of therapeutic antibodies to Fc receptors. ...

Best Practices in Formulation and Lyo Development

Baxter BioPharma Solutions | 13-Feb-2017 | Technical / White Paper

The ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose,...

Functional Comparability of a Biosimilar

SGS | 19-Sep-2016 | Technical / White Paper

Regulatory authorities require head-to-head comparison at multiple levels to demonstrate that a proposed biosimilar is “similar or highly similar” to the...

Manufacturing Recombinant Protein Therapeutics under Cost Constraints

Rentschler Biotechnologie GmbH | 16-Jun-2016 | Product Presentation

Therapeutic proteins such as monoclonal antibodies and fusion proteins represent one of the fastest growing segments in the drug pipeline, which puts pressure...

Survey Report: State of the Biopharmaceutical Industry 2016

William Reed | 14-Jun-2016 | Insight Guide

In May 2016, BioPharma-Reporter conducted its inaugural ‘state of the industry’ survey. The key objective of the poll was to gauge views about the current...

Mycoplasma Detection in Biopharmaceuticals

SGS Life Science Services | 16-May-2016 | Technical / White Paper

The detection of mycoplasma contamination is of utmost concern in bio-therapeutic and vaccine manufacturing. The two pharmacopeia techniques rely on the...

In search for “A cell line for Life”

Fujifilm Diosynth Biotechnologies | 23-Nov-2015 | Technical / White Paper

The key to developing an elegant, robust and manufacturing-ready process starts during cell line and process development. Early identification of the expression...

Lyophilisation Parameters to Eliminate Surface Cracks

Patheon Inc | 19-Oct-2015 | Data Sheet

Learn about the correlation between lyophilisation cycle parameters and cake morphology in a biosimilar product. The presence of cracks on the surface...

New White Paper: Multiplexing in Bioanalysis

SGS Life Science Services | 28-Sep-2015 | Technical / White Paper

SGS scientists have validated a multiplex, bead-based immunoassay which determines nine cytokines simultaneously per sample, resulting in savings in costs,...

How sustainability efforts could change your supply chain for the better

World Courier | 14-Sep-2015 | Technical / White Paper

Going green is moving from a clichéd corporate phrase to simply the way business is run. Companies around the globe continue to make significant investments...

Using Multiple Techniques in Protein Characterization

SGS Life Science Services | 25-May-2015 | Case Study

The aggregation of biopharmaceuticals is a complex process, for efficient analysis it’s essential to carefully select orthogonal methods to minimize gaps...

Single-use systems designed for your workflow

Thermo Fisher Scientific | 01-Apr-2015 | Technical / White Paper

Fluid transfer is an integral part of any biopharmaceutical manufacturing process, and one that can prove challenging. Choosing a customized, single-use...

Demonstrate Biosimilarity of Insulin Biosimilars

SGS Life Science Services | 30-Mar-2015 | Technical / White Paper

Download this white paper to learn about two SGS developed assays used to show comparability in reactivity between the reference product and the biosimilar...

The whole blood assay: Detection of broad spectrum of pyrogens & examples of medical device testing

Merck KGaA, Darmstadt, Germany | Recorded the 09-Apr-2015 | Webinar

Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard...

GPEx® Expression System Increased Production of Pritumumab in a CHO Cell Line

In this case study poster presentation, the GPEx®  mammalian expression technology was used for the production of Pritumumab and compared to human hybridoma...

Three steps to obtain the ‘best’ recombinant CHO cell line

Fujifilm Diosynth Biotechnologies | 23-Feb-2015 | Technical / White Paper

When developing efficient, high quality biomanufacturing processes, it is imperative that the expression system (‘host cell line’ and ‘vector’) and the...

Customized Biosimilarity Analytical Testing from Catalent

Catalent Pharma Solutions | 09-Feb-2015 | Technical / White Paper

Assessment of biosimilar molecules requires an orthogonal analytical approach.  Any one particular analytical technique is not able to fully define the...

Accelerated Biosimilar Development From Catalent Biologics

Despite the controversy surrounding the thicket of regulatory requirements for approval of biosimilars in various markets, regulatory agencies and governments...

Broad spectrum pyrogen detection

EMD Millipore | 08-Dec-2014 | Application Note

The Monocyte-Activation Test (MAT), which was introduced into the European Pharmacopoeia in 2010, detects pyrogens in pharmaceuticals. It covers a much...

The scalable solution to consistent cell culture

Thermo Fisher Scientific | 07-Nov-2014 | Case Study

From research through to full scale bioproduction, you need a system that delivers reliable results, makes effective use of space and is easy to scale...

Directed evolution creates superior CHO cell lines

Fujifilm Diosynth Biotechnologies | 03-Nov-2014 | Data Sheet

Directed evolution is an iterative approach where selective pressure is applied to a system to identify variants with desirable characteristics, in this...