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Framework to Biologics – Part Three

Part One: Biologics and the Problem with Residual DNA 

Part Two: Cell-Based Bioassays 

Part Three: Micro-Flow Imaging

In this final post of our biologics blog series, bioassay scientists will construct a guide to the components of micro-flow imaging: imaging, counting and sorting, plus sample requirements.

Imaging
Micro-Flow Imaging™, or MFI, couples microfluidics with digital microscopic imaging to determine particle size and concentration in biologics and injectables. The concept of Micro-Flow Imaging is very simple. If a particle moves through the flow cell, the particle is imaged and counted. The principles of flow cytometry, microfluidics, microscopy and digital imaging are combined into one instrument.

Sub-visible particles can be unintentionally present in parenterals as a byproduct of drug formulation and manufacturing. This type of analysis allows for the visual assessment of the types of particles present in a solution. Particles that can be present in biopharmaceutical preparations are silicone oil, air bubbles, protein aggregates, rubber pieces from closures and glass shards.

Topics: Thought Leadership Biologics

How to Run a Successful Clinical Study the First Time - Part Two

Adam Kujath, Site Director at Alcami’s API manufacturing and development facility in Germantown, Wisconsin, recently spoke about the business challenges clients face, and the circumstances that led to the successful resolution of this customer’s issues. In this second part of the series, Kujath addresses supply chain management and strategies involving the API process.

To recap, when an innovative New England-based biotech company needed a fresh batch of Active Pharmaceutical Ingredients (API) for a quickly approaching clinical trial, they turned to Alcami.The neuroscience pioneer company previously partnered with Alcami and the proposed work would help secure their next round of financing. The biotech company utilized other vendors for formulation, solid-state and analytical services, believing they had their process under control. They later realized a fragmented supply chain and non-integrated control strategy led to a six month delay, requiring a repeat of their clinical study. The company relied on Alcami next for rapid and robust API manufacturing support.

Topics: Thought Leadership

SCIENTIST SPOTLIGHT: August 2017

Name: Ari Ericson
Alcami Site: Germantown, WI

How long have you been with Alcami?
I joined Alcami in May 2015.


What is your role? 
I am a Process Engineer II in the manufacturing technology group and a development work cell lead at Alcami's Germantown, Wisconsin site.

What is the most rewarding part of your job?
The most rewarding part of my job is working with R&D and operations to manufacture a high quality product for our clients. I get to engage with R&D to develop a robust process for the plant, and then support operations during manufacture.  I strive to enhance the skills of others to provide the necessary efficiency to meet client and site manufacturing expectations.   

Topics: Alcami Voices

Executive Voice: Leading a Shift from Wilmington to RTP

Dr. Stephan Kutzer, CEO, President and Chairman of Alcami Corporation, sits down with the Triangle Business Journal to discuss the transition of Alcami's global headquarters to Research Triangle Park (RTP). 

From a business strategy perspective, why did Alcami decide to move its planned headquarters expansion from Wilmington to Durham?

Our Wilmington operation is an instrumental part of our service offering. Over the last three years, we have invested heavily in new laboratory and manufacturing capacities, and the site enjoys an excellent reputation with the regulatory authorities and our clients. As we continue to grow and expand into new technology platforms, for example HPAPI (highly potent active pharmaceutical ingredients), controlled substances and biologics, we learned that this expansion has to happen in a pharmaceutical hub. 

Topics: Company News

How to Run a Successful Clinical Study the First Time - Part One

When an innovative New England-based biotech company needed a fresh batch of Active Pharmaceutical Ingredients (API) for a quickly approaching clinical trial, they turned to Alcami. The neuroscience pioneer company previously partnered with Alcami and the proposed work would help secure their next round of financing. The biotech company utilized other vendors for formulation, solid-state and analytical services, believing they had their process under control. They later realized a fragmented supply chain and non-integrated control strategy led to a six month delay, requiring a repeat of their clinical study. The company relied on Alcami next for rapid and robust API manufacturing support.

Adam Kujath, Site Director at Alcami’s API manufacturing and development facility in Germantown, Wisconsin, recently spoke about the business challenges clients face, and the circumstances that led to the successful resolution of this customer’s issues.

Topics: Thought Leadership

Framework to Biologics – Part Two

Part Two: Cell-Based Bioassays

In part one of this biologics series, leading Alcami experts established the biologic challenges resulting from residual DNA. In this second part, we will build upon the fundamentals of bioassays.

Biological assays (bioassays) use biological substrates and entities to determine the critical quality attributes of a drug product. These applications are suitable to both small molecules and large molecules (i.e., biologics). While these assays typically exhibit more variability than chemical-based assays, bioassays provide vital tools in the assessment of product toxicity and potency.

Topics: Thought Leadership Biologics

Pitfalls of a Non-Integrated Drug Development Process

When your company decides to explore options to develop your drug product, there are endless possibilities. However, this excitement is often quickly followed by a daunting list of possible avenues to go from clinical to commercial.

The vision that allowed you to get this far has been realized, but now you face an entirely new challenge. You must decide between an integrated or a non-integrated drug development approach, determining whether to use multiple vendors for the API, solid state development on API, drug product and analytical services. Which approach will be the fastest, most cost-effective and ulitmaley reduce risk? With each choice, you must be weigh your priorities and adjust your risk tolerance.

Topics: Thought Leadership

Framework to Biologics – A Three Part Series

Part One: Biologics and the Problem with Residual DNA

In this three-part series, members of Alcami’s biotech team share their experiences working with biologics. This first section sets up a solid foundation for understanding host cell impurities in biopharmaceutical products.


As opposed to traditional drug production, the production of biological products (biologics) requires the involvement of human, animal or microbial cells. Biologics are some of the most effective and cutting-edge therapeutics, such as vaccines and antibodies that are produced through recombinant protein technologies. Biologics produced in cell culture contain unique impurities, including host cell proteins and host cell DNA. Therefore, the World Health Organization (WHO), the European Pharmacopoeia, and the US Food and Drug Administration (FDA) have established strict regulatory guidelines to guarantee product quality in the drug substance.  

Topics: Thought Leadership Biologics

ON-DEMAND WEBINAR: The Future State of Supply Chain Solutions

Join Alcami for a webinar to learn more about the future state of supply chain solutions.

From quality issues and drug shortages, to warning letters and natural disasters, today’s risks are significant and supply disruptions can be catastrophic. Therefore, having a secondary supply chain “on-call” is a must. When developing this innovative dual sourcing strategy, validation of processes with a reliable and flexible supplier protects against supply interruption. Alcami has designed Protect Your Brand™, a first-to-market initiative, to aid in the protection of supply chains.

Topics: Webinars Supply Chain

Open House: Join Us at Our New St. Louis, MO Site

Join Alcami for an open house at our brand new St. Louis, Missouri site, located in the Cortex Innovation Community- the Midwest’s leading center for bioscience and technology research, development and commercialization. The event will include tours of our new state-of-the-art facilities, a site overview presentation, and Q&A lunch with members of our leadership team. 

Topics: Events