Newsletter | December 10, 2024

12.10.24 -- 2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality?

SPONSOR

Strong collaboration is vital to the Sponsor/CDMO relationship, and it can be facilitated through a four-step tech transfer strategy. This approach comprises a pre-transfer evaluation, creating a tech transfer plan, producing engineering and development batches, and lastly, manufacturing clinical trial product and registration batches. Learn more

INDUSTRY INSIGHTS

Best Practices In The Design Of A Pharmaceutical Manufacturing Facility

A well-designed manufacturing facility is critical to ensuring product quality and regulatory compliance. Let's examine the importance of the concept design review in achieving these goals.

Digitalization Of The Lab: Rethinking The Lab In A Digital World

Digitization alone does not enhance scientific insights, optimize lab processes, or deliver new outcomes. Learn about the digitalization journey for labs and a vision for the QC lab of the future.

Breaking The Misconceptions Of Maximum Compression Force

Explore maximum compression force as it relates to the type of tool steel being used and the properties of the tablet punch materials.

Harnessing Digitalization In Legacy Pharmaceutical Manufacturing

Digital technologies are revolutionizing cleaning validation in decades-old pharmaceutical facilities. Examine innovative non-intrusive methods to overcome the digital divide in legacy equipment.

Importance Of Chain Of Custody For Commercial Pharma Distribution

As more new biologics achieve market acceptance, the need for reliable, demonstrable temperature control during shipping has underscored the importance of a robust, reliable chain of custody.

The Critical Role Of Weight Uniformity In Tablet Manufacturing

For tablet manufacturers, tablet weight uniformity plays an essential role in ensuring pharmaceutical products deliver accurate amounts of key ingredients in a formulation.

How To Select A Tracer Gas Leak Detection Method And Technology

Here, we outline the best practices for leak testing of components in a broad range of applications and provide practical advice regarding the use of leak testing equipment.

Delivery Of RNAi Therapeutics Through Drug-Eluting Implants

Conventional delivery methods for RNA therapeutics face limitations. Implant devices deliver a higher concentration of the therapeutic and offer sustained release for improved efficacy.

21 CFR Part 11 Data Management Is The Basis Of Data Integrity

Learn about FDA regulation 21 CFR Part 11 and the critical role it plays in ensuring pharmaceutical and medical product manufacturers properly manage and track their data.

Effective Cleaning Strategies For Irregular Surfaces In Cleanrooms

Explore effective strategies and cleaning supplies to ensure irregular cleanroom surfaces, such as light switches, door handles, valves, and piping, maintain the same standards as more accessible areas.

Mixing Cannabis-Infused Products

Gain insights from a pharmaceutical equipment manufacturer on factors cannabis manufacturers should consider when they are looking to purchase a mixer.

Cleanroom Data Analytics To Consider When Setting Up EM

Discover innovative software that addresses the need of pharmaceutical manufacturing plants to centralize and trend data from various sources important to environmental monitoring (EM) systems.

Strategic Space Management

A pharmaceutical company facing storage space issues decided to outsource its reference samples to Q1 Scientific, a stability storage service provider, resulting in cost savings.

Re-Engineering A Complex Process For FDA Compliance

Examine the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

Are These 5 Misconceptions Keeping You From Modernizing QC?

Explore common misconceptions that obstruct progress and why overcoming these barriers early provides a competitive edge when preparing for commercialization.

Every Component Counts In Single-Use Systems For Storing And Shipping

The logistics of decoupling drug substance manufacturing from final drug product formulation is now possible using integrated single-use freeze-thaw assemblies that incorporate reliable components.

How Document Control Software Supports Digital Transformation Efforts

Embrace digital transformation in pharma manufacturing with advanced document control and quality management systems to enhance compliance, streamline processes, and accelerate time to market.

Continuous Flow — An Emerging Alternative

Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.

Navigating Your Holistic Approach To CCI For Biologic Drug Products

Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.

Considerations When Outsourcing Your Packaging Operations

Learn how outsourcing this key aspect of bringing products to market can benefit your organization and overall supply chain optimization.

FEATURED EDITORIAL

2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality?

The Pistoia Alliance conducted a survey as a pulse check on which technologies the pharma/biotech industry is investing in and companies' progress integrating new tech into the lab.

SPONSOR

The Pharmaceutical Manufacturing and Packaging Congress (PHARMAP) welcomes to celebrate the 5th anniversary together on 14-15 April 2025 in Berlin, Germany. The closed-door Congress invites top-level management of pharmaceutical companies including supply chain and procurement experts, key packaging specialists, as well as CMOs and CDMOs. Bayer, Merck, Takeda, Ferrer, F. Hoffmann-La Roche, Produlab Pharma, Johnson & Johnson Innovative Medicine are already registered for participation. Register now

SOLUTIONS

Affinity Chromatography Resin For Purifying Recombinant Proteins

Facilitate Compliance With 21 CFR Part 11

Fine Chemical Manufacturing Services: R&D From Concept To Commercial

Cleaning Hormone Residues

Biological Indicators To Fit Your Needs

Integrated Biotech Services: From Strain To Commercial Product

Early Drug Development Made Easy With Small Quantities

Improve The Bioavailability Of Poorly Soluble Drugs

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