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Component Selection Equates to Successful Sterile Fill-Finish Manufacturing

Excerpted from Drug Development & Delivery's Special Feature Section titled, "Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions."

As a contract manufacturer, Alcami provides experience in all aspects of the manufacturing process, including fill volume accuracy, plunger placement, material compatibility, and reduction in line loss. “Many of the prefilled syringe products in the contract manufacturing space are high value, low volume, so assessment of manufacturing capabilities with components selected by the client during the device design process is critical to ensuring our success during an individual manufacturing run or campaign,” says Jacquelyn Uribe, Vice President of Quality Operations at Alcami.

Topics: News & Events Editorials Parenteral Manufacturing

Editorial: Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas

Michael Reel, director of technical services at Alcami, and Quinn McGinnis, process engineer at Alcami, recently contributed to an article in Manufacturing Technology Insights titled Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas. In the article, Reel and McGinnis discuss solutions to pharmaceutical packaging challenges through straightforward case studies.

Topics: Editorials Packaging

Special Feature Editorial: Outsourcing Analytical Testing - Novel Services Elicit Consistent, Quantifiable, & Faster Results

Michael Freeman, associate director and business unit head for lab services at Alcami, recently contributed to an article in Drug Development & Delivery titled Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results. In the article, Freeman explains how Alcami's end-to-end analytical testing platform supports client programs through every stage of a product's lifecycle, from early phase development activities to commercial support for both small and large molecule products.

 

Topics: Editorials Analytical Testing Analytical Development

Editorial: High-Potency APIs -- Engineered for Safety

Mark Millar, director and business unit head for API at Alcami, recently participated in the high-potency APIs section of Speciality Chemicals Magazine. The write-up goes in-depth about investments being made in the high-potency API market and provides an overview into occupational health and safety challenges in manufacturing.

Topics: HPAPI Editorials

Editorial: The Changing R&D Landscape

Dr. Imran Ahmed, Head of Formulation Development at Alcami, recently published an article in Pharma Tech Outlook. The article, The Changing R&D Landscape: Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs), explains that as a result of pharmaceutical products becoming increasingly complex, new regulatory and manufacturing challenges are on the rise.

Excerpt from Ahmed: "The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. After a precipitous fall in new drug approvals during the last two decade of the 20th century, there has been a gradual recovery going into the second decade of the 21st century."

Topics: Regulatory Compliance Editorials Development

Editorial: How to Find Your Secret Source

Alcami recently contributed to a special feature in The Medicine Maker magazine, titled "How to Find Your Secret Source."

Excerpt from Alcami: “I have a point of contention with the titles  ‘one-stop shop' or 'specialist supply chain’ because they imply that you can’t have both! If you have independent API and drug product, you can bring these together. Being that we were founded by merging two specialized organizations, we have experts in each area, which we then over arch with a structured offering to make sure they are properly integrated. A key thing our clients tell us – especially smaller clients who don’t want to manage a big supply chain – is that they like the internal efficiencies you can get with a one-stop shop."

Topics: Supply Chain Editorials

Editorial: Considerations for Approval of Biosimilars

Alcami recently contributed to a special feature in the August / September issue of Chemicals Knowledge magazine, titled "Considerations for Approval of Biosimilars."

Biosimilars are sometimes incorrectly considered equivalent to a generic small molecule therapeutic, but for a biologic drug product, the clinical and regulatory pathways are quite different. Alcami Commercial Development Manager Cheryl Johnson explains the distinct differences in the FDA’s definition, development strategy, and regulatory approval pathways.

Topics: Regulatory Compliance Biologics Editorials Parenteral Manufacturing

eBook: Analytical Testing in Drug Development

Alcami recently contributed to an eBook produced by Drug Development and Delivery. The eBook, titled "Analytical Testing in Drug Development," features four companies and explains how they each help the pharmaceutical and biotech industries comply with drug development regulatory requirements. 

Angela Moore, abuse-deterrence studies subject matter expert at Alcami, contributed to the eBook. Her article focuses on considerations for abuse-deterrent Category 1 studies as well as standard syringeability studies.

Topics: Regulatory Compliance Abuse-Deterrence Editorials Development

Editorial: Enabling Technologies Advance Poorly Soluble Highly Potent APIs

Alcami recently contributed to a special feature in Pharmaceutical Technology magazine, titled "Enabling Technologies Advance Poorly Soluble Highly Potent APIs."

Excerpt from Alcami: In fact, challenges in containment can limit the technology that can be deployed for solubility enhancement, according to Adam Kujath, global senior director of manufacturing science and technology at Alcami. “Typical API approaches for solid dosage forms to improve solubility like micronization and spray drying are more difficult to outfit with appropriate containment systems. For instance, milling of solids, while not impossible to do in appropriate containment, poses a challenge since it tends to create dust in the breathing airspace for any worker. For parenteral formulations, lyophilization presents a similar challenge,” he says.

Topics: HPAPI Editorials API Formulations

Editorial: Designing a CMC Strategy for Accelerated Development of Biotherapeutics

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Designing a CMC Strategy for Accelerated Development of Biotherapeutics."

As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity. There are many drivers to accelerate development.

Topics: Regulatory Compliance Biologics Editorials Parenteral Manufacturing