Newsletter | April 7, 2025

04.07.25 -- What Biotechs Learn From Takeda's Internal Manufacturing Competition

INDUSTRY INSIGHTS

Discovery Through Commercialization: A Biologic Drug's Analytical Journey

Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more.

Challenges Associated With In-Use Simulated Administration Of Biologics

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

5 Best Practices To Ensure Quality Active Pharmaceutical Ingredients

It is important to develop robust, reliable processes to safeguard APIs. Review several best practices for providing patients with the highest quality treatment that meets their therapeutic requirements.

FEATURED EDITORIAL

What Biotechs Learn From Takeda's Internal Manufacturing Competition

Biotechs can learn about outsourcing facility selection from a pharma company like Takeda, who evaluates both internal and external locations to place its development and manufacturing projects. This is part two of Chief Editor Louis Garguilo's discussion with Takeda Linz's Roland Fabris.

Back To Supply-Chain And Outsourcing Basics

Vince Kosewski, KALA BIO, and Kishore Hotha, Dr. Hotha’s Life Sciences, remind us that our recent outsourcing fears should remind us of the fundamentals for approaching supply-chain decision-making.

Using Digital Shadows To Reinforce Downstream Modeling

This model class transfers real-time information in one direction, and it can help bridge the gap between digital model and fully functioning digital twin.

INDUSTRY INSIGHTS CONTINUED

Lessons In Scaling Lipids Production And Purification

The rapid scale-up of mRNA drug manufacturing is impressive but has exposed supply chain vulnerabilities for essential ingredients like lipids.

Application Of Plant And Process Models

Begin optimizing biopharmaceutical manufacturing with integrated, sustainable, and cost-effective solutions that enhance efficiency and facility utilization.

Overcoming Challenges In Combination Product Manufacturing

Blending pharmaceuticals and medical devices into a single product offers immense potential for patient care, but manufacturing these combination products presents unique hurdles.

Rapid Analytics: De-Risking Platform Strategies In Biopharma Development

Harness the power of platform strategies and proven expertise, streamlining your drug development process while ensuring quality, consistency, and efficiency at every step.

The Downstream Process: Playing A Crucial Role In Extracting Essence

For bispecific antibodies (bsAbs), the goal of downstream process development is to develop a method for obtaining highly purified bsAbs with optimal recovery and quality.

Partners For Life Strategy

The biopharmaceutical industry faces a multitude of challenges. Learn how a collaborative outsourcing partnership based on trust and transparency can foster efficient and high-quality drug production.

Streamline The Path To FIH Trials With Advanced Cell Line Development

Many CDMOs cannot handle complex recombinant proteins, which often require a CLD process fully integrated with other CDMO components, including analytics and formulation development.

Wrap-Around Labeler Ideal For Small Vials, Cartridges And Syringes

In situations calling for the reliable labeling of medical products, the limitations of fully automatic machines are quickly exposed by extremely small batches and/or products prone to overbalancing.

SOLUTIONS

Integrated Biotech Services: From Strain To Commercial Product

Backed by Lonza’s more than 30 years’ expe­rience and expertise, we offer our customers a full “one-stop-shop” service package at all stages of development and production.

Antibody Drug Conjugates: Link Your Antibody To Its Fullest Potential

Witness how our parallel development service works seamlessly with our existing antibody capabilities, helping to accelerate your ADC program and reach market faster.

Developing A mAb For A Small Biotech Developing Precision Medicines

Corvus, a small biotech developing precision medicines, primarily for oncology patients, was seeking to develop a monoclonal antibody called CPI06, now known as Mupadolimab.

Experience The Benefits Of Primary Drug Containers

The use of cyclic olefin copolymer (COC) allows for much greater design flexibility, and the creation of more robust containers, whilst also allowing the removal of potentially harmful materials.

60 Years Of Providing Manufacturing Solutions To Patients

Discover why partners trust Lifecore Biomedical for safe, high-quality injectable pharmaceuticals as they celebrate 60 years of manufacturing excellence and innovation.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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