Name: Bhadresh Nayee
Alcami Site: Edison, NJ

How long have you been with Alcami?
I have been with Alcami since 2007.

What is your role? 
I’m working as a microbiology analyst at our Edison, New Jersey site. My day-to-day activities involve antibiotic testing, container closure integrity testing, and isolating/creating cultures of bacteria to study the impact of these microorganisms in order to obtain information on types and levels of microbial contamination.

What is the most rewarding part of your job?
The most rewarding part of my job is our clients' satisfaction from my work.

Alcami’s St. Louis, Missouri Center of Excellence for advanced analytical testing was issued a Certificate of Compliance by the European Medicines Agency (EMA) Tuesday, April 23, 2019, following the facility’s recent successful Good Manufacturing Practice (GMP) inspection. Certification confirms the site is compliant with GMP laboratory storage and testing practices, and enables the laboratory to process more commercial products for the European Union (EU). The outcome reflects the company’s unwavering commitments to quality, reliability, responsible operations, and strict adherence to regulatory compliance.

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.

Alcami employees, their families, and friends celebrated Earth Day 2019 by cleaning up green spaces, beaches, waterways, sidewalks, and streets in the company’s local communities. More than 30 volunteers participated in this year’s preservation efforts, including cleanups at Wrightsville Beach, Carolina Beach, and Isle of Palms Beach, near Wilmington, North Carolina and Charleston, South Carolina; business park and nature trail litter removal in Germantown, Wisconsin; and growing new plant life in Durham, North Carolina. Combined, these efforts will protect native wildlife and enhance public gathering places for all to enjoy.

Solid state chemistry plays a major role in successfully developing a compound into a drug product. The physical and mechanical properties are important in selecting the most appropriate stable form with sufficient solubility. The occurrence of crystallization from a crude reaction mixture is the first step towards obtaining a pure drug substance.

For process chemists crystallization is an essential tool for isolation and purification of the compound in a robust and reproducible way. In addition, the crystallization conditions impact the crystal form or polymorph, particle habit, and its characteristics like stability and bio-availability. Optimized pharmaceutically-acceptable crystallization conditions are established by varying cooling profile and slurry conditions, by adding anti-solvent, or by applying seeding to obtain the preferred form, if needed.

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.

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.

Over the years, the US Pharmacopeia (USP), International Harmonisation (ICH), Product Quality Research Institute (PQRI), and several other industry consortia have developed guidelines and best practices for these extractables & leachables studies.

Alcami has specialized knowledge of the most common materials of construction such as platinum-cured silicon, halobutyl rubber, cyclic olefins, polyethylene terephthalate (PET), polyvinyl chloride (PVC), and other elastomers. Vial and stopper configurations, spray pumps, and intravenous (IV) bags are among the most common packaging system components we evaluate. We welcome all routes of administration, including the more challenging prefilled syringes, blow-fill sealed vials, and laminated cans.

Solid state chemistry is the study of the synthesis, crystal structure, and properties of solid phase materials. This area of inquiry and analysis is particularly relevant to explore the properties of oral solid dosage formulations.

In the graph provided below, the six pillars of solid state chemistry are illustrated with subcategories included to give further understanding of what solid state chemistry encompasses. Alcami fields this combined experimental and analytical capability through its own Center of Excellence (CoE) for solid state chemistry and crystallization, which is located in its active pharmaceutical ingredient (API) development facility in Weert, Netherlands.

Name: Czarina Carino
Alcami Site: Durham, NC

How long have you been with Alcami?
It will be my 11th year with Alcami in June.

What is your role? 
I am a scientist in the pharmaceutical development laboratory at our Durham, North Carolina site. I evaluate, develop, validate test methods, perform abuse deterrence studies, and train analysts in specialized analytical methods.

What is the most rewarding part of your job?
The most rewarding part of my job is completing and executing a test successfully– be it an evaluation, development, validation, or a special research project– because a successful execution entails a lot of things– company filing a new drug application (NDA) on time; a timely manufacture of a drug product; sharing experiences and knowledge; contributing to the site’s goals, and most of all, helping to ensure that a product delivered to the patient is safe, has integrity, and is of high quality.