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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

Regulatory Requirements for Early Phase Drug Product Development

Supporting a compound from discovery to clinical phases and potentially commercial phases requires an immense amount of time, energy, and money. Regulatory management is paramount during the drug development pipeline funnel, and recognizing Current Good Manufacturing Practices (CGMPs) is the foundation of drug safety and efficacy.

Every country has its own regulatory authority, responsible for enforcing rules and regulations and issuing guidelines for drug development, licensing, registration, manufacturing, marketing, and labeling of pharmaceutical products.[1]

Topics: Thought Leadership Regulatory Compliance Drug Product Preclinical Studies

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

White Paper: Structural Characterization of Biologics Using High-Resolution Mass Spectrometry

Biopharmaceutical products represent up to 20 percent of the total pharmaceutical market and are growing at a rate of nearly eight percent annually. To keep up with this impressive growth rate, many contract development and manufacturing organizations (CDMOs) are making strategic investments in equipment and expertise to support analytical development and structural characterization of biopharmaceuticals in more economical and efficient ways.[1] Unlike small molecule active pharmaceutical ingredients (APIs) that exist as a single chemical entity, biologics nearly always exist as a mixture of molecules. Different molecules can arise from numerous sources including N-terminal variants, post-translation modifications (PTMs), glycoforms, and degradation products. Due to the potentially high amount of heterogeneity in the biologic, it is critical to demonstrate control over the drug substance (DS) manufacturing process from fermentation to purification and protein re-folding. Characterization of the various molecules is the first step in demonstrating process control. High-resolution mass spectrometry is a key component in the characterization of novel biologics and biosimilars.

Topics: Thought Leadership Resource Center Biologics Analytical Development

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: Thought Leadership Biologics Analytical Development Parenteral Manufacturing

eBook: Elemental Impurities

The US Pharmacopeia (USP) retired the existing wet chemistry heavy metals methods outlined in USP General Chapter <231> with an instrument-based approach on January 1, 2018. Though the existing wet chemistry methods have been in effect for nearly 100 years, the methods were non-specific and frequently failed to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredients. 

Throughout this guidebook, Alcami scientists will discuss heavy metal regulations, moving to a risk-based approach, the role of risk assessment in the manufacturing process, goals and accountability, and agency-accepted testing and filing strategy for elemental impurities

 


Topics: Thought Leadership Resource Center Elemental Impurities Analytical Development

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