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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: Thought Leadership HPAPI Editorials CDMO API Formulations API Containment HPAPI 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: Thought Leadership Regulatory Compliance Biologics Editorials CDMO Parenteral Manufacturing Cell and Gene Therapies

Editorial: Novel Therapies Roundtable Discussion

Alcami recently contributed to a roundtable discussion in Pharma's Almanac magazine, answering the question:

"What truly novel therapies in the earliest stages of discovery and development do you believe will have a significant impact in the future?" 

The article shares insights to this question from Alcami, along with other companies in the biologics space.

Topics: Thought Leadership Biologics Editorials Development

Editorial: Overcoming the Opioid Overdose Crisis

Alcami recently contributed to an article in the Greater Wilmington Business Journal titled, "Overcoming the Opioid Overdose Crisis."

Our community has come together, like many others, to combat the opioid crisis. Several local agencies have rallied to create impactful community resources. A 2016 survey by Castlight, which listed Wilmington, NC as the #1 city for opioid abuse in the United States, was a wake-up call to the level of severity this community has been affected by opioid-related fatalities and hardships. At Alcami, we work with our clients to develop abuse deterrence medicines to help combat this nationwide epidemic that hits home, even here in Wilmington.

Topics: Thought Leadership Abuse-Deterrence Editorials

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. 

Take a Virtual Tour of Our Sterile Fill Line 1

Topics: Thought Leadership Editorials Drug Product Formulations Parenteral Manufacturing

Editorial: Oral Solids Endure & Evolve

Alcami recently contributed to an article in Contract Pharma titled "Oral Solids Endure & Evolve."

Contract Pharma talks with several contract service providers about the state of the oral solid dose development and manufacturing market.

The oral solid dose (OSD) development through manufacturing pipeline of products is expanding at a robust rate—even while industry watches the investment, interest and demand for biologics and biosimilars growing rapidly. There are several reasons OSDs continue to be the most popular dosage form for getting drugs to patients. In addition to being cost effective and relatively easy to make compared to their large molecule counterparts, they are most importantly, patient friendly, especially among the pediatric and geriatric populations.

Take a Virtual Tour of Our Granulation Suite

Topics: Thought Leadership Editorials Oral Solid Dose

Editorial: HPAPIs - A CDMO View

Alcami recently contributed to an article in Specialty Chemicals Magazine titled "HPAPI's: A CDMO View."

Alcami has gained extensive knowledge on HPAPI manufacturing from building new suites at its US API development and manufacturing site

Over the course of 2016-2017, global CDMO Alcami built and qualified a new facility for highly potent compounds at its facility in Germantown, Wisconsin. During the design phase, says Adam Kujath, global senior director of manufacturing science & technology, the company put considerable thought into what was needed to match its existing capabilities – it has a very diverse customer base and works with many different molecules – to market needs.

Take a Virtual Tour of Our HPAPI Suites

Topics: Thought Leadership HPAPI Editorials HPAPI Manufacturing

Editorial: Fuelling Pharma's Innovation Engines

Alcami President & Chief Executive Officer Dr. Stephan Kutzer recently took part in an interview for Manufacturing Chemist titled "Fuelling Pharma's Innovation Engines." 

According to Stephan, small and mid-size pharma and biologics companies are the innovation engines of the industry. “Each year, the number of new INDs and NDAs increases and we anticipate this trajectory to continue. We see more than 5000 clinical introductions on an annual basis. Cancer treatments are a particular area of focus for many of our clients and we expect our pipeline for these therapies to grow within the next 5 years. Our target accessible market is around $8 billion.”

KR: How does Alcami plan to grow with the industry?

SK: We have strategically invested in capability extensions and operational excellence initiatives to better meet industry demand. At our Germantown (Wisconsin, USA) Center of Excellence for API development, scale-up and commercialisation, we have supplemented our existing pipeline with HPAPI suites and controlled substance capabilities.

Topics: Company News Thought Leadership Editorials

Editorial: Outsourcing Analytical Testing - The Gateway to Drug Manufacturing

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Outsourcing Analytical Testing: The Gateway to Drug Manufacturing."

Alcami: Customizing Programs to Meet Accelerated Product Timelines

Alcami is a CDMO that offers fully integrated, comprehensive analytical testing to support technologies for every stage of development. Its laboratory services platform is comprised of analytical testing and development services for small molecule and biologics drug products, as well as specialized offerings such as elemental impurities, abuse deterrence, and extractables and leachables. In addition, formulations development scientists address challenges related to new chemical entities.

Topics: Thought Leadership Editorials Analytical Testing

Editorial: A Practical Approach to Extractables & Leachables

Alcami recently authored an article featured in Drug Development & Delivery titled "A Practical Approach to Extractables & Leachables." 

INTRODUCTION

The study of extractables and leachables (E&L) has been evolving for many years. As pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it. Many of the case studies that initiated interest in extractables and leachables are based on primary packaging. In some cases, the secondary or tertiary packaging were identified as sources of leachables. As a result, the primary emphasis of extractables screens has been on the packaging systems. The approach to these screens is well established. The first iterations of regulatory guidance addressed the common packaging materials in the United States Pharmacopeia (USP) chapter <661>, which relied heavily on physiochemical testing to characterize the material of construction but did not directly address extractables testing of the final packaging materials in detail. With advancements in the manufacture of plastics and increasing variety of base polymers used for packaging systems, it became evident that more specific guidelines are needed.

Topics: Thought Leadership Extractables & Leachables Editorials