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FEATURED EDITORIAL


We Need More University-Based CDMOs

What the outsourcing world needs now is university-based or -affiliated, CDMOs.
So says Joanne Beck, COO, Boston Pharmaceuticals, and whose career has spanned
Amgen, Abbott/AbbVie, Shire, and Celgene.

 * FDA Releases Pre-Launch Activities Importation Requests (PLAIR) Guidance
 * Biopharma In China: The Emerging Global Force Of Domestic Suppliers

 * Therapeutic Oligonucleotides: Regulations & Quality Standards
 * Calculating Process Capability Of Cleaning Processes With Partially Censored
   Data
 * Biopharma Partnerships: The Key To Filling The Life Sciences Innovation Gap
 * Breaking Down The CDMO Size Barrier
 * New ICH Q14 Guidance Applies QbD To Analytical Procedures
 * Key Considerations In Early-Stage Biopharma Financing
 * Here’s How To Grow With Your CDMO


GUEST COLUMNISTS

 * Calculating Process Capability Of Cleaning Processes With Partially Censored
   Data
   
   When cleaning sample results are below the detection limits (DLs) of an
   analytical method, these data are known as "non-detects" or "left-censored"
   data. There are basically two…

 * Biopharma Partnerships: The Key To Filling The Life Sciences Innovation Gap
   
   The life sciences industry is facing a significant slowdown due to patent
   expirations. Many organizations have not established a robust enough pipeline
   to overcome the revenue to…

 * New ICH Q14 Guidance Applies QbD To Analytical Procedures
   
   ICH's new draft guidance (Q14) for Analytical Procedure Development describes
   an enhanced approach for method development, validation, and life cycle
   management employing elements of quality by design (QbD) and risk management
   tools. This article…

 * Key Considerations In Early-Stage Biopharma Financing
   
   After over two years of soaring IPO valuations and high stock prices, biotech
   had a reckoning in the back half of 2021. But while the industry is clearly
   facing headwinds, there’s significant cause for optimism for early-stage
   biotechs looking for funding, not the…

 * Make This Your New EU IDMP Implementation Strategy
   
   Just when the life sciences industry was as sure as it could be that EU
   Iteration 1 of ISO Identification of Medicinal Products (IDMP) implementation
   for centralized procedures in Europe was ready to go, the EMA announced a
   change of plan. Until further notice, the…

 * Gene Therapy Competitive Dynamics: Winner Takes All?
   
   A one-time gene therapy treatment with the potential to cure patients could
   create a “winner takes all” dynamic, whereby second and later entrants for
   the same indication would have significantly smaller patient populations. The
   extent to this dynamic will…

 * Key Considerations For Decarbonizing Your Biotech Facility
   
   Biopharmaceutical manufacturing processes do not directly utilize fossil
   fuels, but fossil fuels are used in the generation of raw materials,
   consumables, packaging, and in supplying energy to building systems and
   manufacturing equipment. This article looks at…

 * How Will Advanced Computing Technologies Catapult Medtech Into The Future?
   
   There is an almost unlimited profit potential for medtech manufacturers to
   use advanced computing technologies such as AI, faster and smaller computing
   hardware…

More From Guest Columnists


PHARMA OUTSOURCING WHITE PAPERS

 * Addressing The Evolving Needs Of Variable Drug Delivery Regimens
   
   Pharmaceutical companies now have a wearable solution designed to enable new
   delivery formats in alternate settings and customization to support
   adjustments to formulations and variations in treatment regimens.

 * Assessing End-To-End Drug Development Partnerships
   
   As drug development becomes increasingly expensive and complex, pharma
   companies are relying on CDMOs. Consider the opportunities and challenges of
   end-to-end arrangements.

 * Integrated First-In-Human Services To Streamline End-To-End Development And
   Manufacturing
   
   Lonza’s SimpliFiH®️ Solutions offering is designed to simplify and accelerate
   the development pathway, even for APIs with challenging properties, such as
   low aqueous…

 * Principles Of Raman Spectroscopy And Application To Pharma Development
   
   Learn how Raman spectroscopy is used to analyze a chemical compound’s
   structure and an example of how this technique is used to analyze amorphous
   material created…

 * Considerations For Improving Outcomes In Biopharmaceutical Process
   Development
   
   In this article, we take a look at how the biopharmaceutical process outcome
   can be improved by increasing the performance and robustness of the
   bioprocess workflow…

 * Biotech's Mirrored Universe: Predictive Engineering And Digital Twinning
   
   The biotechnology industry now can harness advanced engineering techniques
   that have helped save astronauts, save energy, and save countless millions of
   dollars.

More Pharma Outsourcing White Papers


PHARMA OUTSOURCING APP NOTES & CASE STUDIES

 * Leveraging Commercial Packaging Expertise Early To Ensure Successful Scaling
   From The Clinical Stage
 * The Cell & Gene Talent Crunch: Attracting Top-Notch Employees In A
   Competitive Landscape
 * Specialty Medicines: Keys To The Packaging Process From Clinical To
   Commercial Launch
 * Early Plasmid Optimization For Long-Term Commercial Success
 * Keys To Successful Risk Management In Clinical Trials

More Pharma Outsourcing App Notes & Case Studies


NEWSLETTER ARCHIVE

 * 05.24.22 -- Key Considerations To Drive Bioprocess Innovation
 * 05.23.22 -- Fixed-Dose Combination Products: Advantages And Challenges
 * 05.23.22 -- Process Development: Rodney Dangerfield Of Outsourcing?
 * 05.21.22 -- Resources For End-To-End Inhalation Expertise

More Newsletters
 * We Need More University-Based CDMOs
 * Breaking Down The CDMO Size Barrier
 * Here’s How To Grow With Your CDMO
 * Process Development: The Rodney Dangerfield Of Outsourcing?
 * Catching Lightning In A Biopharma: Now What?

More From Chief Editor Louis Garguilo



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CONTENT COLLECTIONS

 

In this latest collection of interviews, CEOs share their views on the current
thinking, strategies, and trends in the cell-therapy space regarding
outsourcing, and working with external partners.

More Content Collections


PRODUCTS & SERVICES

 * AxiChrom™ Chromatography Columns
 * Analytical Testing CDMO Services
 * Gibco BioProduction Services
 * 4CHO Fed-batch Media And Feeds
 * High Potency Manufacturing
 * Parenteral Manufacturing Contract Manufacturing & Services
 * Best Practices For Evaluating A Perfusion Medium
 * Clinical Trial Packaging & Labeling

More Products & Services


INDUSTRY NEWS

 * BD And Mitsubishi Gas Chemical Have Signed A Letter Of Intent (LOI) To
   Discuss A Partnership Agreement To Explore New Ways To Advance Biologic Drug
   Delivery
 * Be Bio And Resilience Announce Strategic Collaboration To Manufacture
   Engineered B Cells, A New Class Of Cellular Medicines
 * Piramal Pharma Solutions New API Plant In Canada Goes Online; Initial
   Production Runs Successfully Completed
 * Biopharma First: CPC’s AseptiQuik® Genderless Connector Makes Sterile
   Connections And Disconnections Using One Product
 * Ionetix And Atonco Sign A Partnership Agreement To Fight Bladder Cancer
 * AGC Biologics Invests In Viral Vector Suspension At New U.S. Campus
 * Grand Opening Of Kodiak Sciences’ Purpose-Built Bioconjugation Facility To
   Support Potential Commercial Manufacture Of KSI-301, An Antibody Biopolymer
   Conjugate For Retinal Diseases
 * Bavarian Nordic To Manufacture First Freeze-Dried Doses Of Smallpox Vaccine
   Upon Exercise Of Contract Option By The U.S. Government
 * LGM Pharma’s Unique Mix Of API Sourcing And CDMO Services Is Fueling Robust
   Growth
 * Vertex Announces Further Expansion In The Boston Seaport At Dedication Of The
   Jeffrey Leiden Center For Cell And Genetic Therapies
 * Ricoh To Strengthen Support For Drug Discovery Services Using mRNA
 * Procaps Group To Acquire Grupo Somar (Including Química y Farmacia, Gelcaps
   And Related Entities) From Advent International, Gaining An Important
   Presence In Mexico, The Region's Second Largest Market
 * ABL And Odimma Therapeutics Join Forces In Personalized Cancer Immunotherapy
 * EV Biologics Signs MSA With LONZA Cell & Gene Therapy

More Industry News


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