Newsletter | December 22, 2025

12.22.25 -- How AI Is Rewriting Tech Transfer Timelines

Outsourced Pharma Newsletter | December 22, 2025 | View web version here.

INDUSTRY INSIGHTS

Top 5 Cell Line Development Challenges (And How To Avoid Them)

The top five common cell line development pitfalls — scalability, stability, complexity, analytics, and tech transfer — can be avoided with experienced partners and integrated, predictive strategies.

Meeting Annex 1: A Proactive Approach To Regulatory Compliance

It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.

Quality By Design: How Laboratory Capabilities Enhance CDMO Partnerships

Successful CDMO partnerships in sterile manufacturing depend on advanced laboratory capabilities, transparent collaboration, and integrated systems that transform challenges into advantages.

FEATURED EDITORIAL

How AI Is Rewriting Tech Transfer Timelines

By replacing trial-and-error with virtual simulations and predictive analytics, AI is giving even small biotechs the process development capabilities once reserved for Big Pharma — and slashing tech transfer timelines in the process.

The Promise And Paradox Of QbD

The difference between QbD as burden and QbD as advantage lies in critical thinking supported by structure — a hierarchy of metrics, toolsets, and tailored platforms.

INDUSTRY INSIGHTS CONTINUED

Optimizing Bispecific Antibody Expression Via Multi-Omics Analysis

Discover how diagnosing ribosome pausing sites and optimizing codon usage dramatically improves bispecific antibody titers, turning difficult-to-express candidates into viable therapeutics.

Utilizing Fed-Batch Intensification To Increase Titer In Biologics Manufacturing

Learn how the advanced principles of process intensification can be applied to process and equipment design, increasing facility throughput, and ultimately offering a wide range of benefits to customers.

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.

High-Throughput Formulation Development For High-Concentration mAbs

See how a high-throughput microwell plate platform economically screens a model IgG1 mAb at 120 mg/ml across 96 formulations while minimizing protein use and maximizing data output.

De-Risking Your Bioconjugate's Path To Clinical Manufacturing

Explore the challenges when moving a bioconjugate candidate from early development to clinic, along with integrated solutions for navigating this growing area of the biopharmaceutical industry.

Partners For The Planet: Sustainability Review

In this report, we review concrete examples of projects across a global network that are contributing to the successful achievement of sustainability goals and aspirations.

How Does A CMO Define Legacies?

Partner with a CMO that combines expertise, innovation, and trusted global capabilities to bring life-changing therapies to patients faster and more reliably.

SOLUTIONS

Factors Which Impact mAb Process Scale-Up

Thinking about your mAb scale-up processes early on can help avoid common pitfalls. Cytiva’s Fast Trak scientists discuss factors that can influence a successful scale-up outcome.

Leveraging Advanced Technology And Proven Expertise

By leveraging our proprietary non-viral gene insertion technology, GPEx® Lightning ensures rapid development timelines and high-yield production, making it an ideal solution for complex biologics.

A Cell Line For Enhanced Antibody Effector Function

GS Effex® has been engineered to lack the enzyme responsible for the addition of fucose, α1,6-fucosyltransferase. This industrially relevant cell line produces antibodies free of fucose.

Achieve Your Commercialization Goals For Sterile Injectables

You can count on our extensive scientific and manufacturing expertise, stringent quality standards, and highly responsive customer service to ensure timely delivery of your life-changing products.

Capabilities Update October 2025: Analytical Services

We offer an end-to-end solution, covering every stage of biologic drug development, from early clone selection and small-scale manufacturing to process scale-up, large-scale production, and quality control.

Self-Administered Disposable Autoinjector

BD Physioject Disposable Autoinjector offers a proven, user-friendly platform for self-injection, enhancing patient comfort, safety, and adherence across multiple chronic disease treatments globally.

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. 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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