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 be lost. To bridge this innovation gap, pharma CEOs will need to expand their use of alliances, in tandem with bolt-on M&A, as a pipeline booster strategy.
- Make This Your New EU IDMP Implementation Strategy
- Key Considerations For Decarbonizing Your Biotech Facility
- 3 Keys To A Fit-For-Purpose Compliance Strategy In Decentralized Pharma
- The Single-use Bioprocessing Bottleneck & Looking Ahead
- Technical Due Diligence Considerations For Multi-Site Biopharma Acquisitions
- Tech Due Diligence: Acquiring A Biopharma Manufacturing Facility
- A Better Path For CMO Relationships As The Pandemic Continues
GUEST COLUMNISTS
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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 Digital Application Dataset Integration (DADI) user interface will be used to enable structured data submissions.
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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 key facility decarbonizing considerations using a case study with quantification of estimated costs.
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3 Keys To A Fit-For-Purpose Compliance Strategy In Decentralized Pharma
Outsourcing and technology have morphed our industry into a new decentralized model. Now, each sponsor must carefully develop an ongoing compliance strategy considering its unique business model and its influence on the drug development journey. Strategies are needed to design QMS' that can expand and pivot in tandem with corporate and clinical development.
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The Single-use Bioprocessing Bottleneck & Looking Ahead
Are you asking, What happened to the bags promised for my product? The single-use system bag market had been seeing strains as early as 2018, and COVID-19 made the demand worse. This article looks into the factors contributing to the demand. Normalization of the supply chain may continue to be delayed, but it will eventually even out.
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Technical Due Diligence Considerations For Multi-Site Biopharma Acquisitions
Part 1 of this 2-part article series shared considerations for standalone biopharma manufacturing facility acquisitions. This article, Part 2, shares considerations for multi-site acquisitions when the seller is manufacturing part or all its products in-house.
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Tech Due Diligence: Acquiring A Biopharma Manufacturing Facility
As a consultant, this author has been approached on several occasions to perform on-site technical due diligence for facilities that his clients were considering to acquire. In this article, he shares the considerations you should keep in mind when acquiring a stand-alone biopharma manufacturing facility.
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A Better Path For CMO Relationships As The Pandemic Continues
In this article, we discuss how drug sponsors and service providers can better work together to continue down the path of outsourcing success that has been highlighted during the pandemic.
BIOSIMILAR WHITE PAPERS
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Strategies For Upstream Intensification
Upstream intensification is one strategy that will enable the Facility Of The Future by significantly driving down costs through an increase in volumetric productivity. Read the white paper to learn more!
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Guidelines For A High Cell Density Cryopreservation Process8/11/2021
A discussion on the integration of high cell density cryopreservation in the seed train andkey considerations for developing a cryopreservation process including choice of cryoprotectant and freezing techniques.
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Accelerate CHO Cell Characterization With The Blazar™ Rodent Panel2/24/2021
The Blazar Rodent Panel allows biopharma to move away from traditional in vivo antibody production assays when characterizing cell banks of rodent origin used in the production of biologicals.
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Turnkey Solutions To Improve Cell Culture Performance2/16/2022
This white paper describes the benefits of a one-step and neutral pH feed optimization strategy, as well as the potential application of chemically defined hydrolysates.
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Cell Therapy Scale-Up Strategies For Commercial Success9/30/2020
This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development.
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8 mm Needle – Improving Subcutaneous Chronic Drug Delivery7/21/2020
Reducing needle length can improve the risk profile of subcutaneous injections and can make injecting viscous formulations easier and quicker.
BIOSIMILAR APP NOTES & CASE STUDIES
- Fundamentals Of Size Exclusion Chromatography
- Implementing GMP For Early-Phase Development With Cartesian Therapeutics Co-Founder And CEO, Dr. Murat Kalayoglu
- Accelerating cGMP Production Using Rapid Tech Transfer
- Capture Of Histidine-Tagged Molecules Using Biacore His Capture Kit
- Cellvento® 4CHO Fed-batch Medium

- The Biosimilar Leadership Playbook: 5 Tips For Success
- Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business?
- The Biosimilar Toolbox: How To Ratchet Up Biosimilar Competition In 2021
- The Top 5 Biosimilar Developments Of 2020
- Will These Big Biosimilar Questions Be Answered In 2021?
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.
More Content CollectionsBIOSIMILAR DEVELOPMENT 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
- Viatris And Biocon Biologics Launch Abevmy® (Bevacizumab), Their Third Oncology Biosimilar, In Canada
- United Kingdom First To Grant Licence For Teva’s Ophthalmology Biosimilar Ongavia (ranibizumab)
- Alvotech Announces Positive Results From A Pharmacokinetic Similarity Study For AVT04, A Proposed Biosimilar To Stelara
- JSR Life Sciences Launches 'Similis Bio' To Help Partners Accelerate Biosimilar Development
- Formycon AG AND ATHOS KG Announce Closing Of Transaction To Acquire Biosimilar Assets FYB201 And FYB202 As Well As Bioeq GmbH
- FDA Approves Alymsys® (bevacizumab-maly), A Bevacizumab Biosimilar Developed By mAbxience
- First Subject Dosed In Phase 3 Clinical Trial Of Pertuzumab Biosimilar HLX11