Bio-Outsourcing

Internal Standard (IS) Variation Case Studies: Emerging from Three Common IS Challenges

Content provided by WuXi AppTec | 20-Oct-2023 | Application Note

The use of internal standards (IS) is essential for developing and applying liquid chromatography-tandem mass spectrometric (LC-MS/MS) quantitative bioanalytical...

ICH M10 Guidance: Harmonization and Modification to Bioanalytical Method Variation

Content provided by WuXi AppTec | 20-Oct-2023 | Application Note

Global regulatory standards govern bioanalytical method development, validation and the subsequent assays. When those standards are updated, industry stakeholders...

Achieving consistency in process development of mRNA therapeutics

Content provided by Thermo Fisher Scientific - Biosciences | 07-Jun-2023 | Insight Guide

Selecting raw materials is one of the earliest steps in the development of mRNA vaccines and therapeutics. The materials you choose have the potential...

Process optimization for mAb commercial manufacturing

Content provided by Catalent | 01-Jun-2023 | Product Presentation

Process characterization and validation is an important step in the product development journey and late-phase development, and it is required before transferring...

Considerations for Process Characterization of Biologics

Content provided by Catalent | 04-Apr-2023 | Insight Guide

Process characterization is an important step in the product development journey. Download this Q&A article to learn the latest trends, status, and...

eBook: mRNA prospects and scale-up solutions

Content provided by Thermo Fisher Scientific - Biosciences | 22-Mar-2023 | Insight Guide

This mRNA eBook was created by Thermo Fisher Scientific, in collaboration with Genetic Engineering & Biotechnology News (GEN), to provide you with...

Impurity profiling and analysis of TheraPure GMP nucleotides

Content provided by Thermo Fisher Scientific - Biosciences | 22-Mar-2023 | White Paper

Nucleoside triphosphates (NTPs) are vital components of emerging RNA therapeutics and vaccines. Controlling impurities that may be present in them while...

Create Better Biologic Treatments with Catalent

Content provided by Catalent | 21-Feb-2023 | Product Brochure

Deliver safe and stable products to your patients with the help of Catalent Biologics' Limoges, France site, a European Center of Excellence for early-phase...

Trends in Biopharmaceutical Raw Material Selection

Content provided by Actylis – The Partner of Choice | 31-Jan-2023 | Business Advice

Join us as our in-house experts, along with Cecile Bellamy from Pfizer, discuss current and future trends in biopharmaceutical raw material selection.

Stand-alone GMP & non-GMP Analytical Solutions for Large Molecules

Content provided by Catalent | 17-Jan-2023 | Product Brochure

Catalent offers one of the most extensive selections of biologics analytical services in the industry. We have over 30 years of experience developing and...

Supporting first lyophilised mRNA vaccine to trial

Content provided by Recipharm AB | 28-Nov-2022 | Case Study

When Arcturus presented its mRNA vaccine candidate to Recipharm, it was at the stage of a frozen product, a ready-to-administer sterile injectable for...

Liposomal and Nanoparticle Technology

Content provided by Pfizer CentreOne | 18-Nov-2022 | White Paper

Medical science is continuously searching for better ways to administer drugs into the body and to maximize the therapeutic effectiveness of the drugs...

GMP manufacturing of buffers and liquid blends

Content provided by Actylis – The Partner of Choice | 16-Nov-2022 | White Paper

Actylis manufactures buffers, process solutions, cleaning solutions, Water for Injection (WFI) for further processing, and custom liquid blends in compliance...

The value of mRNA vaccines & therapeutics

Content provided by Curia | 14-Nov-2022 | White Paper

The number of clinical trials featuring RNA-based drug products has increased dramatically since 2020.

Custom manufacturing of protease inhibitor PMSF

Content provided by Actylis – The Partner of Choice | 09-Nov-2022 | White Paper

By combining 75+ years of manufacturing and sourcing expertise, Actylis provides a wide portfolio of GMP ingredients to the pharma & biopharma market,...

Discover Catalent Biologics’ Premier European Site

Content provided by Catalent | 01-Nov-2022 | Product Brochure

Catalent Biologics’ Anagni, Italy facility is a world-class, late-stage, and commercial product launch site offering sterile and biologics manufacturing...

Choose Catalent to Launch Your Biologics in Europe

Content provided by Catalent | 25-Oct-2022 | Product Brochure

With over 30 years of experience producing sterile drug products, Catalent Biologics is your premier manufacturing and packaging partner in Europe. We...

dPCR Case Study

Content provided by CellCarta | 08-Aug-2022 | Case Study

Streamline your adoptive cell therapy program with digital PCR. Our team has a unique expertise in digital and quantitative PCR to support you in ensuring...

The Reagents Behind Much of Molecular Biology

Content provided by Thermo Fisher Scientific | 25-Jul-2022 | Case Study

The ability to amplify, modify and fabricate DNA is fundamental to modern molecular biology. Why do so many researchers take their constituent parts for...

Microsampling in Early Phase Drug Development

Content provided by Altasciences | 10-May-2022 | 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

Content provided by Baxter BioPharma Solutions | 16-Feb-2022 | 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

Content provided by Baxter BioPharma Solutions | 16-Feb-2022 | 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

Content provided by 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

Content provided by 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

Content provided by Viral Safety for mAb: Prevent, Detect, Remove | 23-Nov-2020 | 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

Content provided by Viral Safety for mAb: Prevent, Detect, Remove | 16-Nov-2020 | 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

Content provided by 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

Content provided by Take the Right Path Upstream with MilliporeSigma | 02-Nov-2020 | 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

Content provided by 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

Content provided by 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

Content provided by 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

Content provided by 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

Content provided by 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.

Content provided by 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

Content provided by Take the Right Path Upstream with MilliporeSigma | 01-Oct-2020 | 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)

Content provided by 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

Content provided by Take the Right Path Upstream with MilliporeSigma | 01-Sep-2020 | White Paper

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

Upstream Intensification – Enabling Perfusion Processes with Cell Retention Technologies

Content provided by Take the Right Path Upstream with MilliporeSigma | 05-Aug-2020 | White Paper

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

Reducing The Risk During Cell And Gene Therapy Development And Manufacturing

Content provided by MilliporeSigma - Gene Therapy | 05-Aug-2020 | White Paper

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

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

Content provided by Take the Right Path Upstream with MilliporeSigma | 20-Jul-2020 | 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

Content provided by Take the Right Path Upstream with MilliporeSigma | 20-Jul-2020 | 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

Content provided by 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

Content provided by 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

Content provided by Eppendorf Bioprocess Solutions | 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

Content provided by 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

Content provided by Eppendorf Bioprocess Solutions | 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

Content provided by 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

Content provided by Baxter BioPharma Solutions | 13-Feb-2017 | 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,...