INSIGHTS ON DRUG DEVELOPMENT

  • Lentiviral Vector Scale-Up Workflow In Single-Use Bioreactors Enables GMP Compliance
    Lentiviral Vector Scale-Up Workflow In Single-Use Bioreactors Enables GMP Compliance

    As gene transfer vehicles, lentiviruses exhibit many desirable properties, such as high transduction efficiencies, ability to infect both dividing and nondividing cells, and stable integration into the host cell genome. These properties make them well-suited for in vivo and ex vivo gene and cell therapies. However, cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.

  • Quality Matters – SEC Analysis For Antibody Aggregates
    Quality Matters – SEC Analysis For Antibody Aggregates

    Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

  • Kaleido Biosciences Successfully Meets Aggressive IND Filing Thanks To Strategic Partnership
    Kaleido Biosciences Successfully Meets Aggressive IND Filing Thanks To Strategic Partnership

    Designed specifically for new and emerging companies such as Kaleido Biosciences, The Quick to Care™ program is an integrated solution that combines drug substance and drug product development, clinical manufacturing, forecasting, demand planning and clinical trial supply execution managed by a single program manager.

  • Managing The Challenges Of Small Batch Formulations
    Managing The Challenges Of Small Batch Formulations

    A risk-based investment in understanding GMP manufacturing at small scales can prevent costly issues during scaling development that ultimately affect the timely delivery to patients in need.

  • Is Your Complex Formulation Process Set Up For Success?

    Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.

  • Preparing For Your CDMO Selection Process

    Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing. Don't be unprepared from the outset of your search. 

  • Corynex Protein Expression: Simplifying Recombinant Protein Production

    The rise of biologics is having a dramatic impact on how physicians treat many serious and chronic illnesses. Pharmaceutical companies looking to add biologics to their pipelines must come up with innovative ways to approach drug development and cut the high costs associated with it. In this white paper, we review how the Corynex® Protein Expression System uses an extensive toolbox to improve the levels of protein secretion and overall success rate.

  • Scaling A mAb Production Process To A Single-Use Platform

    The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.

More Insights On Drug Development

DRUG DEVELOPMENT SOLUTIONS

  • Particle Control In Biopharmaceuticals

    Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.

  • Surfactant Analysis Services

    Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.

  • cGMP Support Services
    cGMP Support Services

    With nearly 30 years of providing cGMP CMC analytical services to the pharmaceutical, biotechnology and medical device industries, Nitto Avecia Pharma Services has a proven track record of providing testing and phase-appropriate validation services for nearly all dosage forms from pre-clinical through post-mark life cycle management (including potent and controlled substances).

  • Lonza: CDMO Offerings Span Complete Biopharma Product Lifecycle
    Lonza: CDMO Offerings Span Complete Biopharma Product Lifecycle

    Ibex Solutions, from Lonza, consist of three innovative CDMO offerings that span the complete product lifecycle of a biopharmaceutical – from preclinical to commercial stages, from drug substance to drug product, all in one location. 

  • Corporate Overview Brochure
    Corporate Overview Brochure

    Nitto Avecia Pharma Services is a premier contract development and manufacturing organization offering a comprehensive range of cGMP services including formulation development, parenteral manufacturing, and a complete package of CMC analytical services for small to large molecules and nearly all dosage forms

More Drug Development Solutions

INDUSTRY EVENTS

Effective Batch Record Review – Getting It Right The First Time January 8 - 8, 2020
1:00pm - 2:30pm EST, Online Training
Duration:  90 minutes
Price:  $299 - Includes Bonus Handouts!
Clinical Research Project Management - 7 Breakthrough Behaviors For Success January 14 - 14, 2020
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error January 15 - 15, 2020
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
The MHRA Data Integrity Guidance Clarified: What it Means for Industry & Patients January 16 - 16, 2020
1:00 PM - 2:30 PM EST
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Best Practices for Deviation Investigations: Cost-Effective Problem Correction February 11 - 11, 2020
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!