Thailand news Covid -19 Update

By Pharmaceutics International, Inc

Innovating During the COVID-19 Pandemic

We Are Grateful for the Continued Efforts and Dedication of Our Employees to Ensure Uninterrupted Supply of Medicines to Our Customers and Patients.

Pharmaceutics International, Inc., (Pii) is a premier CDMO, offering unparalleled scientific insight and depth of product knowledge, while supplying high-quality dosage forms that enhance the lives of patients worldwide. Pii provides customized and flexible solutions across several dosage forms and has experience with a broad range of compounds. For 25 years, Pii has been supporting its pharmaceutical partners (from virtual to multinational) with extensive technical capabilities, knowhow, and the highest level of customer service. With more than 400 development programs completed, Pii’s scientific team has extensive experience working with drug substances representing a range of physicochemical characteristics (and challenges). Pii’s specialized capabilities, multiproduct facilities, and in-depth knowledge allow them to work with potent compounds and hormones, develop complex dosage forms, and support varied manufacturing processes.

Continuous investment and innovation are core elements of Pii’s strategy, helping to ensure the company remains maximally relevant to prospective biopharmaceutical partners by delivering on all commitments. In addition to recruiting the industry’s best talent, Pii seeks avenues for further innovation, continues to build cuttingedge technology assets, and reinforces its existing pharmaceutics know-how to empower scientific advancement, to share knowledge, and to pursue excellence across the entire organization.

Pii continually monitors evolving industry trends and technical innovations to stay ahead of forthcoming challenges and proactively develop solutions and services to overcome potential issues. One major driver of change is the ongoing evolution toward increasingly personalized medicine, which in some instances translates into lower production demands or higher-value products. Processing costly drug substances — which often require further enhancements of containment procedures — increases the requirements for innovation in drug development and formulation. Pii is always investing in people and capabilities. One recent example is an expansion of sterile capabilities, including lyophilization and a new fully robotic filling line for small batch processing, in response to increased demand for sterile product processing.

Formulation expertise will become increasingly critical as new modalities enter commercialization and drug products become even more complex. Pii continues to track industry developments regarding biologics, microbiome therapeutics, and cell and gene therapy, expanding their expertise and capabilities where they can determine the best synergies.

In addition to the flexibility that Pii’s facilities offer customers, such as dedicated production suites, they have been able to adapt standard processing practices to accommodate some very unique programs. The company has a long history of problem-solving and, through close collaboration with customers, continues to innovate to progress product development.

Pii is currently in discussion with several existing and prospective customers to support product development initiatives related to COVID-19, including antiviral therapeutics and vaccines. Thus far, the COVID-19 crisis has not impacted Pii’s regular operations, as we have become adept at working in an increasingly “self-monitored” environment. We are grateful for the continued efforts and dedication of our employees to ensure uninterrupted supply of medicines to our customers and patients. From the beginning, Pii has been declared an essential business by our local government, allowing us to sustain full operation and employment for our teams. Our employees have worked diligently to assure continuity of supply and to keep all R&D projects on track.

Employee safety remains our number one priority. To help ensure the safety of our employees and partners and to protect supply to patients, we have taken extensive actions — in line with guidelines issued by the U.S. CDC, the WHO, and local authorities where we operate — including re-emphasizing good hygiene practices, severely r estricting visitor access to our sites, reorganizing our workflows to maximize social distancing, limiting employees to business-critical travel (where permitted by local government policy), facilitating safer commuting alternatives, and employing remote-working strategies. We continue to survey deep into our supply chain and have not identified any significant risk, delay, or concern that may have a substantial effect on delivery of any product or clinical trial supplies.

Our operations, procurement, business development, and project management professionals are dedicated to maintaining business as usual and ensuring any potential delays are mitigated. We wish to express our thanks to all our customers and partners for your trust, collaboration, and support. Pharmaceutics International, Inc., (Pii) is a premier CDMO, offering unparalleled scientific insight and depth of product knowledge, while supplying high-quality dosage forms that enhance the lives of patients worldwide. Pii provides customized and flexible solutions across several dosage forms and has experience with a broad range of compounds. For 25 years, Pii has been supporting its pharmaceutical partners (from virtual to multinational) with extensive technical capabilities, knowhow, and the highest level of customer service. With more than 400 development programs completed, Pii’s scientific team has extensive experience working with drug substances representing a range of physicochemical characteristics (and challenges). Pii’s specialized capabilities, multiproduct facilities, and in-depth knowledge allow them to work with potent compounds and hormones, develop complex dosage forms, and support varied manufacturing processes.

At Pharmaceutics International, Inc. (Pii), our motto is “challenges frame opportunities.” We are a contract development and manufacturing organization (CDMO) with a passion for problem-solving. Emphasizing collaboration, our experts complete projects on time with the highest quality standards, all from our Hunt Valley, Maryland campus.

Pii’s campus includes four cGMP and FDA inspected facilities, 70 manufacturing suites with all the necessary analytical testing capabilities on site, and four integrated aseptic filling suites delivering quality, safety, and efficiency. Experienced with small and large molecule compounds, we have special expertise in developing and manufacturing complex parenteral products, extended release formulations, and non-aqueous injectable drug products. We can also overcome stability challenges with precision lyophilization cycle development and production.

Pii’s Pharmaceuticals Know-How™ can quickly and safely advance your drug from discovery through clinical testing to commercialization. Find out more at www.pharm-int.com

Article by sandvik Coromant

Heart and leg of a champion How Sandvik Coromant helped “Monster” Mike to create a truly life-changing innovation

Passion, determination and a large dose of entrepreneurial spirit have allowed Mike Schultz to thrive in his career despite the loss of a limb.

Life presents each of us with challenges from time to time, but rarely is the challenge the loss of a

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limb. In an instant, the ability to climb a staircase or tie a shoe – things that most people take for granted – can suddenly become far more difficult. This was the case with Mike Schultz, but he refused to let that event prevent him from making the most of his life. “Monster” Mike Schultz, a snowmobile racer since his high school days, went pro in 2003, and within five years was one of the top five snocross racers in the world. But an accident one winter day in 2008 changed everything.

“I had a bad start during the qualifying race and was pushing hard to catch up so I could make the finals,” says Schultz. “Coming down a hill, though, I got bucked off the sled and landed wrong. My knee basically blew apart.”

Things quickly went from bad to worse. A nearby snowstorm grounded all helicopter flights that day, so Schultz had to ride by ambulance to the nearest trauma centre. “It was five hours before I got to a trauma surgeon,” he says. “They tried to save it, but three days after the accident I’d gone through 47 units of blood and my kidneys were shutting down. The doctors woke me up to tell me they were amputating my leg.”

Schultz spent 13 days in hospital. “I rebounded pretty quickly because of my physical condition,” he says. “They sent me home on Christmas Day. Five weeks later I had my first prosthetic leg. To be able to walk again was an amazing feeling.” Despite this, Schultz thought his racing days were over. “I didn’t want to race if I couldn’t compete at the level I did before. I kind of wrote it off.”

But several months later, he heard about the X Games Supercross Adaptive sports competition and knew then that he had to give it a try. The problem was finding a suitable prosthetic, one that would not only help him compete, but actually win. In order to do so you need a great design and the best quality tooling to ensure a precision fit.

With an indefatigable spirit, help from friends in the racing community and Sandvik Coromant Mike Schultz soon designed and built one ideal for extreme sports.

“Sandvik Coromant supported in the machining process, the materials that are used in the medical field for prosthetics for joints and screws needs to stand up totough conditions. Sandvik Coromant has developed machining techniques and tooling to stand up to those materials. With Mikes hands and Sandvik Coromant tools hecan create groundbreaking innovations, truly life-changing innovations”, says Tiffany Long, Sales Engineer at Sandvik Coromant.

Sandvik Coromant is at the forefront of manufacturing tools, machining solutions and knowledge that drive industry standards and innovations. Since the start in 1942 Sandvik Coromant have been driven by a determination to solving problems and are currently represented in more than 150 countries with over 7,600 staff. The research and development team comprises more than 500 people working at several research and testing facilities around the world. The patent portfolio holds more than 520 patent families, and each year adding 30 to 40 new patents. And also adding some 2,500 new products to the market every year as well as new machining methods and machining concepts that reflect the demands and challenges of new materials and the industry.

Mike Schultz has not looked back since

Less than five months after the accident, Schultz and his new knee raced motocross at Michigan’s Extremity Games, qualifying him for the 2009 ESPN Summer X Games Supercross. “Participating in an event like that was a real eye-opener,” says Schultz. “It opened me up to relationships with other amputees, where I could learn stuff from them, and them from me. From that point on, it’s been a whole new world.” Over the past eleven years, Monster Mike has made a name for himself in the world of adaptive sports, taking home ten gold medals in the Motocross, Snocross, and Snow Bike categories at the X Games competition, as well as gold and silver at the 2018 Winter Paralympics.

Schultz’s name spread even further from his appearance on the American Edge Factor show about modern manufacturing and innovation, which was sponsored at the time by Sandvik Coromant. Sandvik Coromant offers a large of advanced tooling and machining solutions for medical devices: hip joints, bone screws, pedicle screws, dental implants and bone plates

“One of the best ways to share and gain knowledge is to collaborate with others. Sandvik Coromant is the global leader in metal-cutting technology and innovation, it’s part of our responsibility to help our customers be successful in their endeavors as well as to help people outside the industry to understand the value of metal cutting in modern life, By working together we drive continuous improvement and progress and at the same time meet the manufacturing challenges of today and the future.” says Senior Project Leader JoAnn Mitchell, Sandvik Coromant USA, about the sponsorship.

Apart from his passion for all things fast, Schultz has developed another love, this one a gift to athletes like himself. His work on high-performance prosthetics has led him to open his own manufacturing company, BioDapt, which now markets his high-impact, highly adjustable Moto Knee and the VF2 prosthetic sports foot.