CELL AND GENE OUTSOURCING
Sustainable Approaches To Oligonucleotide Manufacturing
An industry expert shares about sustainable Oligo manufacturing approaches that can save time, cost, and resources – while improving purity, quality, and scalability of these promising therapeutics.
An End-To-End Industrialization Roadmap For Autologous Cell Therapy
Explore specificities and challenges, leveraging automation for scalability with the Cocoon® Platform, and building a vein-to-vein network to achieve ‘just-in-time’ delivery of therapies.
How To Apply Quality By Design Principles To Cell And Gene Therapy Release Testing
Review how to develop and use QC assays that can facilitate both product and process understanding and control.
From Platform To Patient: Streamlining Gene Therapy Development
Explore how platform processes advance gene therapies, the impact of strong partnerships on patient access, and the future shaped by these collaborations.
Critical Supply Chain And Logistics Considerations For Cell And Gene Therapy Management
Explore the unique challenges and complexities involved in key CGT logistics areas like donor and patient accessibility, critical raw materials management, and innovative temperature control equipment.
Preparing For FDA Pre-Approval Inspection: Quality And Regulatory Topics
Consider these strategies for meeting quality and regulatory requirements in cell and gene therapies that can also help to identify issues early, reduce risks, and prevent delays and rework.
Mastering The Art Of Developing A Successful Bispecific Antibody
Learn innovative strategies to overcome the complexities of bispecific antibody development, from intelligent design to efficient purification techniques.
Manufacturing Life-Saving Gene Therapies
Take a look behind the scenes and hear firsthand about the commitment to patients and clients at Andelyn Biosciences.
Advancing Viral Vector Manufacturing: The Importance Of The Cell Line
Explore the pivotal role of cell lines in viral vector manufacturing, a complex, multi-step process that has traditionally been both time-consuming and labor-intensive.
Quality Agreements: Defining Governance In CDMO Partnerships
Quality agreements serve a critical role within a CDMO-Sponsor partnership. Review the importance of aligning objectives, quality standards, and compliance frameworks to establish a robust foundation.
Early Developability And Analytical Toolbox For The Production Of Multi-Chain Biotherapeutics
In recent years, the number of biotherapeutic molecules requiring more complex assemblies has greatly increased. Typically, these multi-chain molecules are no longer compatible with platform approaches and require a more agile approach to early developability and method d...
Selecting Containers For Sensitive And Costly Cell & Gene Therapies
Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.
Optimizing Monoclonal Antibody Manufacturing For Commercial Success
Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.
Biopharmaceuticals Development And Manufacturing: Wide-Ranging Expertise And Vertically Integrated Service
The company’s wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art cGMP facilities while ensuring full process and product compliance at all stages of research, deve...
Future-Proof Your Aseptic Filling
Using the Cytiva SA25 Aseptic Filling Workcell, a standardized system designed with flexibility built in, ensures that companies can pivot between products quickly and adapt as manufacturing needs change.
Candidate Screening And Feasibility Studies For Viral Gene Therapies
Create a simple, modular path to cGMP manufacturing that minimizes risk. Explore a strategic approach for early-stage development and how it can propel therapies to the clinic and the market.
Scale-Up Allogeneic Cell Therapies To Large Patient Populations
Achieve your therapeutic and commercial goals by utilizing a tried-and-tested standardized approach combined with the latest technology and reliable analytics.
AAV Analytics: Key Considerations When Developing A Clinical Program
Finding partners with the necessary skills to optimize AAV processes is crucial for minimizing risk. Explore key considerations for advancing your therapy from concept to commercialization.
Accelerating Your Gene Therapy: Not All Platforms Are Created Equal
Standardized methods, materials, and analytics are critical for overcoming hurdles in the gene therapy space. Explore how a platform approach to fast-track AAVs can enhance quality and efficiency.
Tailored CMC Solutions That Meet Needs Of Novel Molecular Biologic Formats
Explore an integrated drug substance/drug product CMC strategy and technical case studies that provide insight into delivering product-specific solutions and enabling the acceleration of novel molecular formats.
Secure And Industrialize Your CGT Process Towards cGMP Manufacturing
Learn the principles of commercialization readiness and guidance to address them in process development as well as the best time to implement automation and minimize commercialization risks.
Viral Vector Manufacturing: Improve Efficiency With A Platform Approach
Learn more about the platform-based scalable suspension process for LVV production and how it is impacting CGTs advancing toward commercialization.
Minaris Advanced Therapies Philadelphia Campus Overview
Our Philadelphia Campus serves as a centralized hub for collaborative efforts, supporting numerous companies throughout the CGT pipeline, from initial research to commercial-scale manufacturing.
Improved And Rebalanced Plasmids To Ramp Up Your AAV Productivity
Growth in rAAV-based therapies is creating a need for dramatically increased production. Learn how AAV productivity can be optimized using platform technologies capable of affording significantly higher titers.
Combining An MVA Technology Platform With Innovative Analytical Methods
Learn how this process development platform for MVA impacts vaccine manufacturing and supports the drug life cycle from process and analytical development through trials and commercialization.
De-Risk Your Path To Clinic With An AAV Suspension Platform
Build a reliable, de-risked path to the clinic while avoiding unforeseen costs and compliance-related delays with advice from Suparna Sanyal, PhD, Head of Viral Vectors Commercial Development.
The CDMO Value Proposition For Your Autologous Cell Therapy
This panel session features a decade-long story of partnership in bringing two life-changing gene therapies to market successfully in 2022.
Revolutionizing How Medicines Are Made, Funded, And Scaled
Hear from site leaders and virtually tour the process and analytical development laboratory and GMP manufacturing facility which includes four additional 2,000L single-use bioreactors.
Building A Strong Safety Culture In The Biopharmaceutical Industry
Explore how fostering a strong safety culture — rooted in accountability, collaboration, and proactive risk management — can drive operational excellence and long-term success in biopharmaceuticals.
Meeting Needs And Exceeding Expectations Worldwide
Whether you are looking to optimize your existing formulations or require full-scale manufacturing solutions, Boehringer Ingelheim BioXcellence™ is dedicated to helping you realize your vision and deliver impactful therapies.