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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 Blogs

Alcami Supporting Potential COVID-19 Treatment

WOODCLIFF LAKE, N.J.—April 16, 2020—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle”), a New Jersey-based pharmaceutical company, today announced that its product RYANODEX® (dantrolene sodium) for injectable suspension inhibited the growth of SARS-CoV-2, the virus causing the COVID-19 pandemic, in a controlled in vitro laboratory test. On Tuesday, April 14, Eagle submitted its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of RYANODEX in patients infected with SARS-CoV-2. Eagle has been in contact with the FDA’s Coronavirus Treatment Acceleration Program (“CTAP”) to request potential expedited review of the IND application and aims to begin the clinical trial as soon as possible.

Topics: News & Events Parenteral Manufacturing Blogs

Alcami Expands its Sterile Fill-Finish Capacity with Acquisition of TriPharm Services

Transaction Advances Alcami’s Strategic Plan by Adding Scale in Attractive and Growing Parenteral Markets

Alcami Investors Make Additional Equity Investment Alongside Ampersand Capital Partners to Fund Expansion

Durham, NC (USA) – January 17, 2020 – Alcami Corporation (“Alcami”), a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced it has acquired TriPharm Services (“TriPharm”), a new state-of-the-art sterile fill-finish manufacturing center located near Research Triangle Park, North Carolina. The acquisition of TriPharm follows the recently announced $17 million expansion of Alcami’s sterile fill-finish facility in Charleston, South Carolina.

Topics: News & Events Parenteral Manufacturing

Alcami Corporation Expanding Operations in Charleston County

Durham, NC (USA) – December 17, 2019 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced plans to expand the company’s current operations in Charleston County. The $17 million investment is expected to create 30 new jobs.

Topics: News & Events Parenteral Manufacturing

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

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

Understanding Biologics: Your Top 7 Questions Answered

The biologics market represents the leading edge of novel therapeutics and is the fastest growing cross-section of the pharmaceutical industry—by some accounts, increasing as much as eight percent annually, or twice the growth rate of small molecule therapeutics. With advancements in DNA technology and increasing investments in personalized medicine, the sky is the limit for the biologics industry. This Q&A with biologics expert, Cheryl Johnson, will address the most common questions asked about this rapidly growing therapeutic field.

Topics: Biologics Analytical Development Parenteral Manufacturing Blogs

Editorial: An Interview with Alcami

Sterile Fill Line 2Alcami parenteral experts recently contributed to an article in Pharmaceutical Outsourcing titled, "An Interview with Alcami."

As new parenteral products are introduced into the market, what are some of the challenges parenteral manufacturers have faced, and how do they solve these challenges?

If current trends hold, it is expected that new parenteral products will be increasingly complex, requiring nonstandard manufacturing technologies subjected to higher standards of regulatory scrutiny and market expectations. With the emphasis on precision medicine— an emerging approach of disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person— there will be a greater number of biologic drugs, multidrug combination products, drug device combinations, and targeted drug delivery systems introduced to the market. Parenteral manufacturing of these complex drug products will require special equipment, technologies, and control strategies. It will also require highly skilled process engineers, manufacturing operators, and quality assurance personnel. Furthermore, a greater number of new molecules will be highly potent requiring special containment facility, environmental controls, and operator training that is not commonly available in many of today’s manufacturing facilities.

Topics: Editorials Drug Product Formulations Parenteral Manufacturing

Video: Charleston Regional Development Alliance Features Alcami

Alcami's Charleston, South Carolina site is featured in a video produced by the Charleston Regional Development Alliance. Be sure to check out the video to see our facility, meet our team, and learn more about the growth in the Charleston area, and the role that Alcami plays.

Topics: News & Events Drug Product Videos Parenteral Manufacturing

Alcami Announces Completion of Site Investment and Expansion in Drug Product Manufacturing and Development Facilities

Wilmington, NC - September 8, 2016 - Alcami Corporation, a leading provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, today announces additional laboratory-scale capabilities to support prefilled syringes in Wilmington, NC and the successful completion of previously announced investments in Charleston, SC.

Alcami has invested in state of the art, semi-automated vacuum stopper equipment in Wilmington, NC, to generate prefilled syringe samples that can be used to screen & select components, complete compatibility studies, and conduct developmental stability studies.  With this equipment, Alcami can generate bench/pilot scale representative samples, minimizing the amount of Active Pharmaceutical Ingredient (API) required to generate this critical data.

Topics: News & Events Drug Product Parenteral Manufacturing